Publisher: Sage Publications   (Total: 1166 journals)

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Showing 1 - 200 of 1166 Journals sorted alphabetically
AADE in Practice     Hybrid Journal   (Followers: 6)
Abstracts in Anthropology     Full-text available via subscription   (Followers: 29)
Academic Pathology     Open Access   (Followers: 6)
Accounting History     Hybrid Journal   (Followers: 18, SJR: 0.527, CiteScore: 1)
Acta Radiologica     Hybrid Journal   (Followers: 1, SJR: 0.754, CiteScore: 2)
Acta Radiologica Open     Open Access   (Followers: 2)
Acta Sociologica     Hybrid Journal   (Followers: 39, SJR: 0.939, CiteScore: 2)
Action Research     Hybrid Journal   (Followers: 53, SJR: 0.308, CiteScore: 1)
Active Learning in Higher Education     Hybrid Journal   (Followers: 395, SJR: 1.397, CiteScore: 2)
Adaptive Behavior     Hybrid Journal   (Followers: 9, SJR: 0.288, CiteScore: 1)
Administration & Society     Hybrid Journal   (Followers: 18, SJR: 0.675, CiteScore: 1)
Adoption & Fostering     Hybrid Journal   (Followers: 25, SJR: 0.313, CiteScore: 0)
Adsorption Science & Technology     Open Access   (Followers: 9, SJR: 0.258, CiteScore: 1)
Adult Education Quarterly     Hybrid Journal   (Followers: 259, SJR: 0.566, CiteScore: 2)
Adult Learning     Hybrid Journal   (Followers: 51)
Advances in Dental Research     Hybrid Journal   (Followers: 11, SJR: 1.791, CiteScore: 4)
Advances in Developing Human Resources     Hybrid Journal   (Followers: 35, SJR: 0.614, CiteScore: 2)
Advances in Mechanical Engineering     Open Access   (Followers: 156, SJR: 0.272, CiteScore: 1)
Advances in Methods and Practices in Psychological Science     Full-text available via subscription   (Followers: 20)
Advances in Structural Engineering     Full-text available via subscription   (Followers: 51, SJR: 0.599, CiteScore: 1)
AERA Open     Open Access   (Followers: 14)
Affilia     Hybrid Journal   (Followers: 6, SJR: 0.496, CiteScore: 1)
Africa Spectrum     Open Access   (Followers: 17)
Agrarian South : J. of Political Economy     Hybrid Journal   (Followers: 3)
Air, Soil & Water Research     Open Access   (Followers: 13, SJR: 0.214, CiteScore: 1)
Alexandria : The J. of National and Intl. Library and Information Issues     Full-text available via subscription   (Followers: 68)
Allergy & Rhinology     Open Access   (Followers: 5)
AlterNative : An Intl. J. of Indigenous Peoples     Full-text available via subscription   (Followers: 39, SJR: 0.194, CiteScore: 0)
Alternative Law J.     Hybrid Journal   (Followers: 12, SJR: 0.176, CiteScore: 0)
Alternatives : Global, Local, Political     Hybrid Journal   (Followers: 12, SJR: 0.351, CiteScore: 1)
Alternatives to Laboratory Animals     Full-text available via subscription   (Followers: 11, SJR: 0.297, CiteScore: 1)
American Behavioral Scientist     Hybrid Journal   (Followers: 26, SJR: 0.982, CiteScore: 2)
American Economist     Hybrid Journal   (Followers: 7)
American Educational Research J.     Hybrid Journal   (Followers: 259, SJR: 2.913, CiteScore: 3)
American J. of Alzheimer's Disease and Other Dementias     Hybrid Journal   (Followers: 23, SJR: 0.67, CiteScore: 2)
American J. of Cosmetic Surgery     Hybrid Journal   (Followers: 9)
American J. of Evaluation     Hybrid Journal   (Followers: 18, SJR: 0.646, CiteScore: 2)
American J. of Health Promotion     Hybrid Journal   (Followers: 35, SJR: 0.807, CiteScore: 1)
American J. of Hospice and Palliative Medicine     Hybrid Journal   (Followers: 47, SJR: 0.65, CiteScore: 1)
American J. of Law & Medicine     Full-text available via subscription   (Followers: 12, SJR: 0.204, CiteScore: 1)
American J. of Lifestyle Medicine     Hybrid Journal   (Followers: 7, SJR: 0.431, CiteScore: 1)
American J. of Medical Quality     Hybrid Journal   (Followers: 13, SJR: 0.777, CiteScore: 1)
American J. of Men's Health     Open Access   (Followers: 9, SJR: 0.595, CiteScore: 2)
American J. of Rhinology and Allergy     Hybrid Journal   (Followers: 11, SJR: 0.972, CiteScore: 2)
American J. of Sports Medicine     Hybrid Journal   (Followers: 247, SJR: 3.949, CiteScore: 6)
American Politics Research     Hybrid Journal   (Followers: 36, SJR: 1.313, CiteScore: 1)
American Review of Public Administration     Hybrid Journal   (Followers: 28, SJR: 2.062, CiteScore: 2)
American Sociological Review     Hybrid Journal   (Followers: 356, SJR: 6.333, CiteScore: 6)
American String Teacher     Full-text available via subscription   (Followers: 3)
Analytical Chemistry Insights     Open Access   (Followers: 26, SJR: 0.224, CiteScore: 1)
Angiology     Hybrid Journal   (Followers: 5, SJR: 0.849, CiteScore: 2)
Animation     Hybrid Journal   (Followers: 15, SJR: 0.197, CiteScore: 0)
Annals of Clinical Biochemistry     Hybrid Journal   (Followers: 10, SJR: 0.634, CiteScore: 1)
Annals of Otology, Rhinology & Laryngology     Hybrid Journal   (Followers: 20, SJR: 0.807, CiteScore: 1)
Annals of Pharmacotherapy     Hybrid Journal   (Followers: 58, SJR: 1.096, CiteScore: 2)
Annals of the American Academy of Political and Social Science     Hybrid Journal   (Followers: 51, SJR: 1.225, CiteScore: 3)
Annals of the ICRP     Hybrid Journal   (Followers: 4, SJR: 0.548, CiteScore: 1)
Anthropocene Review     Hybrid Journal   (Followers: 8, SJR: 3.341, CiteScore: 7)
Anthropological Theory     Hybrid Journal   (Followers: 48, SJR: 0.739, CiteScore: 1)
Antitrust Bulletin     Hybrid Journal   (Followers: 14)
Antiviral Chemistry and Chemotherapy     Open Access   (Followers: 2, SJR: 0.635, CiteScore: 2)
Antyajaa : Indian J. of Women and Social Change     Hybrid Journal   (Followers: 1)
Applied Biosafety     Hybrid Journal   (Followers: 1, SJR: 0.131, CiteScore: 0)
Applied Psychological Measurement     Hybrid Journal   (Followers: 21, SJR: 1.17, CiteScore: 1)
Applied Spectroscopy     Full-text available via subscription   (Followers: 27, SJR: 0.489, CiteScore: 2)
Armed Forces & Society     Hybrid Journal   (Followers: 25, SJR: 0.29, CiteScore: 1)
Arthaniti : J. of Economic Theory and Practice     Full-text available via subscription  
Arts and Humanities in Higher Education     Hybrid Journal   (Followers: 49, SJR: 0.305, CiteScore: 1)
Asia Pacific Media Educator     Hybrid Journal   (Followers: 1, SJR: 0.23, CiteScore: 0)
Asia-Pacific J. of Management Research and Innovation     Full-text available via subscription   (Followers: 3)
Asia-Pacific J. of Public Health     Hybrid Journal   (Followers: 15, SJR: 0.558, CiteScore: 1)
Asia-Pacific J. of Rural Development     Hybrid Journal   (Followers: 2)
Asian and Pacific Migration J.     Full-text available via subscription   (Followers: 8, SJR: 0.324, CiteScore: 1)
Asian Cardiovascular and Thoracic Annals     Hybrid Journal   (Followers: 2, SJR: 0.305, CiteScore: 0)
Asian J. of Comparative Politics     Hybrid Journal   (Followers: 5)
Asian J. of Legal Education     Full-text available via subscription   (Followers: 4)
Asian J. of Management Cases     Hybrid Journal   (Followers: 6, SJR: 0.101, CiteScore: 0)
ASN Neuro     Open Access   (Followers: 2, SJR: 1.534, CiteScore: 3)
Assessment     Hybrid Journal   (Followers: 19, SJR: 1.519, CiteScore: 3)
Assessment for Effective Intervention     Hybrid Journal   (Followers: 15, SJR: 0.578, CiteScore: 1)
Australasian J. of Early Childhood     Hybrid Journal   (Followers: 7, SJR: 0.535, CiteScore: 1)
Australasian Psychiatry     Hybrid Journal   (Followers: 18, SJR: 0.433, CiteScore: 1)
Australian & New Zealand J. of Psychiatry     Hybrid Journal   (Followers: 30, SJR: 1.801, CiteScore: 2)
Australian and New Zealand J. of Criminology     Hybrid Journal   (Followers: 546, SJR: 0.612, CiteScore: 1)
Australian J. of Career Development     Hybrid Journal   (Followers: 5)
Australian J. of Education     Hybrid Journal   (Followers: 51, SJR: 0.403, CiteScore: 1)
Australian J. of Management     Hybrid Journal   (Followers: 13, SJR: 0.497, CiteScore: 1)
Autism     Hybrid Journal   (Followers: 356, SJR: 1.739, CiteScore: 4)
Autism & Developmental Language Impairments     Open Access   (Followers: 16)
Avian Biology Research     Hybrid Journal   (Followers: 6, SJR: 0.401, CiteScore: 1)
Behavior Modification     Hybrid Journal   (Followers: 14, SJR: 0.877, CiteScore: 2)
Behavioral and Cognitive Neuroscience Reviews     Hybrid Journal   (Followers: 27)
Behavioral Disorders     Hybrid Journal   (Followers: 1)
Beyond Behavior     Hybrid Journal   (Followers: 1)
Bible Translator     Hybrid Journal   (Followers: 13)
Biblical Theology Bulletin     Hybrid Journal   (Followers: 24, SJR: 0.184, CiteScore: 0)
Big Data & Society     Open Access   (Followers: 55)
Biochemistry Insights     Open Access   (Followers: 7)
Bioinformatics and Biology Insights     Open Access   (Followers: 12, SJR: 1.141, CiteScore: 2)
Biological Research for Nursing     Hybrid Journal   (Followers: 7, SJR: 0.685, CiteScore: 2)
Biomarker Insights     Open Access   (Followers: 1, SJR: 0.81, CiteScore: 2)
Biomarkers in Cancer     Open Access   (Followers: 11)
Biomedical Engineering and Computational Biology     Open Access   (Followers: 13)
Biomedical Informatics Insights     Open Access   (Followers: 8)
Bioscope: South Asian Screen Studies     Hybrid Journal   (Followers: 4, SJR: 0.235, CiteScore: 0)
BMS: Bulletin of Sociological Methodology/Bulletin de Méthodologie Sociologique     Hybrid Journal   (Followers: 4, SJR: 0.226, CiteScore: 0)
Body & Society     Hybrid Journal   (Followers: 29, SJR: 1.531, CiteScore: 3)
Bone and Tissue Regeneration Insights     Open Access   (Followers: 2)
Brain and Neuroscience Advances     Open Access  
Brain Science Advances     Open Access  
Breast Cancer : Basic and Clinical Research     Open Access   (Followers: 12, SJR: 0.823, CiteScore: 2)
British J. of Music Therapy     Hybrid Journal   (Followers: 9)
British J. of Occupational Therapy     Hybrid Journal   (Followers: 251, SJR: 0.323, CiteScore: 1)
British J. of Pain     Hybrid Journal   (Followers: 31, SJR: 0.579, CiteScore: 2)
British J. of Politics and Intl. Relations     Hybrid Journal   (Followers: 39, SJR: 0.91, CiteScore: 2)
British J. of Visual Impairment     Hybrid Journal   (Followers: 14, SJR: 0.337, CiteScore: 1)
British J.ism Review     Hybrid Journal   (Followers: 18)
BRQ Business Review Quarterly     Open Access   (Followers: 1)
Building Acoustics     Hybrid Journal   (Followers: 4, SJR: 0.215, CiteScore: 1)
Building Services Engineering Research & Technology     Hybrid Journal   (Followers: 3, SJR: 0.583, CiteScore: 1)
Bulletin of Science, Technology & Society     Hybrid Journal   (Followers: 9)
Business & Society     Hybrid Journal   (Followers: 15)
Business and Professional Communication Quarterly     Hybrid Journal   (Followers: 9, SJR: 0.348, CiteScore: 1)
Business Information Review     Hybrid Journal   (Followers: 17, SJR: 0.279, CiteScore: 0)
Business Perspectives and Research     Hybrid Journal   (Followers: 3)
Cahiers Élisabéthains     Hybrid Journal   (Followers: 1, SJR: 0.111, CiteScore: 0)
Calcutta Statistical Association Bulletin     Hybrid Journal   (Followers: 1)
California Management Review     Hybrid Journal   (Followers: 37, SJR: 2.209, CiteScore: 4)
Canadian Association of Radiologists J.     Full-text available via subscription   (Followers: 2, SJR: 0.463, CiteScore: 1)
Canadian J. of Kidney Health and Disease     Open Access   (Followers: 8, SJR: 1.007, CiteScore: 2)
Canadian J. of Nursing Research (CJNR)     Hybrid Journal   (Followers: 15)
Canadian J. of Occupational Therapy     Hybrid Journal   (Followers: 166, SJR: 0.626, CiteScore: 1)
Canadian J. of Psychiatry     Hybrid Journal   (Followers: 28, SJR: 1.769, CiteScore: 3)
Canadian J. of School Psychology     Hybrid Journal   (Followers: 12, SJR: 0.266, CiteScore: 1)
Canadian Pharmacists J. / Revue des Pharmaciens du Canada     Hybrid Journal   (Followers: 3, SJR: 0.536, CiteScore: 1)
Cancer Control     Open Access   (Followers: 2)
Cancer Growth and Metastasis     Open Access   (Followers: 1)
Cancer Informatics     Open Access   (Followers: 4, SJR: 0.64, CiteScore: 1)
Capital and Class     Hybrid Journal   (Followers: 10, SJR: 0.282, CiteScore: 1)
Cardiac Cath Lab Director     Full-text available via subscription   (Followers: 1)
Cardiovascular and Thoracic Open     Open Access   (Followers: 1)
Career Development and Transition for Exceptional Individuals     Hybrid Journal   (Followers: 10, SJR: 0.44, CiteScore: 1)
Cartilage     Hybrid Journal   (Followers: 6, SJR: 0.889, CiteScore: 3)
Cell Transplantation     Open Access   (Followers: 5, SJR: 1.023, CiteScore: 3)
Cephalalgia     Hybrid Journal   (Followers: 8, SJR: 1.581, CiteScore: 3)
Cephalalgia Reports     Open Access   (Followers: 4)
Child Language Teaching and Therapy     Hybrid Journal   (Followers: 34, SJR: 0.501, CiteScore: 1)
Child Maltreatment     Hybrid Journal   (Followers: 11, SJR: 1.22, CiteScore: 3)
Child Neurology Open     Open Access   (Followers: 6)
Childhood     Hybrid Journal   (Followers: 19, SJR: 0.894, CiteScore: 2)
Childhood Obesity and Nutrition     Open Access   (Followers: 12)
China Information     Hybrid Journal   (Followers: 9, SJR: 0.767, CiteScore: 2)
China Report     Hybrid Journal   (Followers: 11, SJR: 0.221, CiteScore: 0)
Chinese J. of Sociology     Full-text available via subscription   (Followers: 5)
Christian Education J. : Research on Educational Ministry     Hybrid Journal   (Followers: 1)
Chronic Illness     Hybrid Journal   (Followers: 6, SJR: 0.672, CiteScore: 2)
Chronic Respiratory Disease     Hybrid Journal   (Followers: 12, SJR: 0.808, CiteScore: 2)
Chronic Stress     Open Access  
Citizenship, Social and Economics Education     Full-text available via subscription   (Followers: 6, SJR: 0.145, CiteScore: 0)
Cleft Palate-Craniofacial J.     Hybrid Journal   (Followers: 8, SJR: 0.757, CiteScore: 1)
Clin-Alert     Hybrid Journal   (Followers: 1)
Clinical and Applied Thrombosis/Hemostasis     Open Access   (Followers: 32, SJR: 0.49, CiteScore: 1)
Clinical and Translational Neuroscience     Open Access   (Followers: 1)
Clinical Case Studies     Hybrid Journal   (Followers: 3, SJR: 0.364, CiteScore: 1)
Clinical Child Psychology and Psychiatry     Hybrid Journal   (Followers: 45, SJR: 0.73, CiteScore: 2)
Clinical EEG and Neuroscience     Hybrid Journal   (Followers: 8, SJR: 0.552, CiteScore: 2)
Clinical Ethics     Hybrid Journal   (Followers: 13, SJR: 0.296, CiteScore: 1)
Clinical Medicine Insights : Arthritis and Musculoskeletal Disorders     Open Access   (Followers: 3, SJR: 0.537, CiteScore: 2)
Clinical Medicine Insights : Blood Disorders     Open Access   (Followers: 1, SJR: 0.314, CiteScore: 2)
Clinical Medicine Insights : Cardiology     Open Access   (Followers: 8, SJR: 0.686, CiteScore: 2)
Clinical Medicine Insights : Case Reports     Open Access   (Followers: 1, SJR: 0.283, CiteScore: 1)
Clinical Medicine Insights : Circulatory, Respiratory and Pulmonary Medicine     Open Access   (Followers: 4, SJR: 0.425, CiteScore: 2)
Clinical Medicine Insights : Ear, Nose and Throat     Open Access   (Followers: 2)
Clinical Medicine Insights : Endocrinology and Diabetes     Open Access   (Followers: 33, SJR: 0.63, CiteScore: 2)
Clinical Medicine Insights : Oncology     Open Access   (Followers: 3, SJR: 1.129, CiteScore: 3)
Clinical Medicine Insights : Pediatrics     Open Access   (Followers: 3)
Clinical Medicine Insights : Psychiatry     Open Access   (Followers: 10)
Clinical Medicine Insights : Reproductive Health     Open Access   (Followers: 1, SJR: 0.776, CiteScore: 0)
Clinical Medicine Insights : Therapeutics     Open Access   (Followers: 1, SJR: 0.172, CiteScore: 0)
Clinical Medicine Insights : Trauma and Intensive Medicine     Open Access   (Followers: 4)
Clinical Medicine Insights : Urology     Open Access   (Followers: 3)
Clinical Medicine Insights : Women's Health     Open Access   (Followers: 4)
Clinical Nursing Research     Hybrid Journal   (Followers: 34, SJR: 0.471, CiteScore: 1)
Clinical Pathology     Open Access   (Followers: 5)
Clinical Pediatrics     Hybrid Journal   (Followers: 25, SJR: 0.487, CiteScore: 1)
Clinical Psychological Science     Hybrid Journal   (Followers: 16, SJR: 3.281, CiteScore: 5)
Clinical Rehabilitation     Hybrid Journal   (Followers: 78, SJR: 1.322, CiteScore: 3)
Clinical Risk     Hybrid Journal   (Followers: 5, SJR: 0.133, CiteScore: 0)
Clinical Trials     Hybrid Journal   (Followers: 22, SJR: 2.399, CiteScore: 2)
Clothing and Textiles Research J.     Hybrid Journal   (Followers: 28, SJR: 0.36, CiteScore: 1)
Collections : A J. for Museum and Archives Professionals     Full-text available via subscription   (Followers: 3)
Common Law World Review     Full-text available via subscription   (Followers: 17)
Communication & Sport     Hybrid Journal   (Followers: 8, SJR: 0.385, CiteScore: 1)
Communication and the Public     Hybrid Journal   (Followers: 2)
Communication Disorders Quarterly     Hybrid Journal   (Followers: 15, SJR: 0.458, CiteScore: 1)
Communication Research     Hybrid Journal   (Followers: 24, SJR: 2.171, CiteScore: 3)
Community College Review     Hybrid Journal   (Followers: 8, SJR: 1.451, CiteScore: 1)
Comparative Political Studies     Hybrid Journal   (Followers: 291, SJR: 3.772, CiteScore: 3)
Compensation & Benefits Review     Hybrid Journal   (Followers: 8)
Competition & Change     Hybrid Journal   (Followers: 12, SJR: 0.843, CiteScore: 2)

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Similar Journals
Journal Cover
Annals of Clinical Biochemistry
Journal Prestige (SJR): 0.634
Citation Impact (citeScore): 1
Number of Followers: 10  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 0004-5632 - ISSN (Online) 1758-1001
Published by Sage Publications Homepage  [1166 journals]
  • Machine learning predictive models of LDL-C in the population of eastern
           India and its comparison with directly measured and calculated LDL-C

    • Free pre-print version: Loading...

      Authors: Anudeep P P, Suchitra Kumari, Aishvarya S Rajasimman, Saurav Nayak, Pooja Priyadarsini
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundLDL-C is a strong risk factor for cardiovascular disorders. The formulas used to calculate LDL-C showed varying performance in different populations. Machine learning models can study complex interactions between the variables and can be used to predict outcomes more accurately. The current study evaluated the predictive performance of three machine learning models—random forests, XGBoost, and support vector Rregression (SVR) to predict LDL-C from total cholesterol, triglyceride, and HDL-C in comparison to linear regression model and some existing formulas for LDL-C calculation, in eastern Indian population.MethodsThe lipid profiles performed in the clinical biochemistry laboratory of AIIMS Bhubaneswar during 2019–2021, a total of 13,391 samples were included in the study. Laboratory results were collected from the laboratory database. 70% of data were classified as train set and used to develop the three machine learning models and linear regression formula. These models were tested in the rest 30% of the data (test set) for validation. Performance of models was evaluated in comparison to best six existing LDL-C calculating formulas.ResultsLDL-C predicted by XGBoost and random forests models showed a strong correlation with directly estimated LDL-C (r = 0.98). Two machine learning models performed superior to the six existing and commonly used LDL-C calculating formulas like Friedewald in the study population. When compared in different triglycerides strata also, these two models outperformed the other methods used.ConclusionMachine learning models like XGBoost and random forests can be used to predict LDL-C with more accuracy comparing to conventional linear regression LDL-C formulas.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-10-06T10:33:11Z
      DOI: 10.1177/00045632211046805
       
  • A UK national audit of the laboratory investigation of phaeochromocytoma
           and paraganglioma

    • Free pre-print version: Loading...

      Authors: Christopher Boot, Barry Toole, Sharman Harris, Lisa Tetlow, Wassif S Wassif
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundPhaeochromocytomas and paragangliomas (PPGL) are catecholamine secreting tumours associated with significant morbidity and mortality. Timely diagnosis and management are essential. A range of laboratory tests can be utilised in the investigation of PPGL. There is scope for significant variation in practice between centres. We aimed to investigate how the laboratory investigation of PPGL is performed in laboratories across the United Kingdom.MethodsA questionnaire consisting of 21 questions was circulated to Clinical Biochemistry laboratories in the United Kingdom via the Association for Clinical Biochemistry and Laboratory Medicine office. The survey was designed to allow audit against Endocrine Society Guidelines on the Investigation and Management of PPGL and to obtain information on other important aspects not included in these guidelines.ResultsResponses were received from 58 laboratories and the data were compiled. The majority of laboratories use either urine or plasma metanephrines in first-line testing for PPGL, although a number of different combinations of biochemistry tests are utilised in different centres. All laboratories measuring metanephrines or catecholamines in-house use LC or LC-MS/MS methods. There are some marked differences between laboratories in urine metanephrines reference ranges used and sample requirements.ConclusionsThere is evidence of good practice in UK laboratories (as assessed against Endocrine Society Guidelines) such as widespread use of urine/plasma metanephrines and appropriate analytical methodologies used. However, there is also evidence of variations in practice in some areas that should be addressed.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-10-02T02:25:24Z
      DOI: 10.1177/00045632211046759
       
  • Samples spiked with pituitary-derived thyroid-stimulating hormone may
           disguise the extent of differences between thyroid-stimulating hormone
           assays

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      Authors: Tejas Kalaria, Jonathan Fenn, Hayley Sharrod-Cole, Anna Sanders, Clare Ford, Rousseau Gama
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundA large discordance in the diagnosis and potential management of hypothyroidism using Abbott and Roche thyroid assays has been reported recently. The difference in Abbott and Roche thyroid-stimulating hormone (TSH) results in these studies was larger than anticipated from the external quality assessment (EQA) reports.MethodsAbbott and Roche TSH method means in UK NEQAS for thyroid hormones distributions 430 to 454 were compared against the amount of TSH spiked. A TSH deplete serum pool was spiked with various concentrations of pooled high TSH serum and 3rd WHO International Standard for TSH (WHO-IS). Four serum pools with TSH close to clinical decision limits were spiked with two concentrations of WHO-IS.ResultsOn review of EQA data, median (IQR) Roche: Abbott TSH ratio was lower (p < 0.001) in 48 pools spiked with TSH (1.11 (1.07–1.16)) compared to 41 pools not spiked (1.29 (1.25–1.31)) and the decrease was proportionate to the contribution of spiked TSH to total TSH in the samples (ρ=−0.908, p < 0.001). In spiking experiments, the relationship of Roche and Abbott TSH was different in TSH deplete pool spiked with WHO-IS (RocheTSH=1.13*AbbottTSH–0.52) and high TSH serum (RocheTSH=1.43*AbbottTSH–0.50), respectively. The Roche: Abbott TSH ratio decreased and the method agreement improved on spiking serum pools with WHO-IS.ConclusionAbbott and Roche TSH assays are not in harmony in human serum samples but the agreement was better in samples spiked with WHO-IS which contains pituitary-derived TSH. Use of pituitary-derived TSH spiked samples, such as provided by EQA schemes, may mask clinically significant between-assay differences.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-09-17T03:15:56Z
      DOI: 10.1177/00045632211042560
       
  • Comparison of ultra-performance liquid chromatography and ARKTM
           immunoassay for therapeutic drug monitoring of voriconazole

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      Authors: Diego Peña-Lorenzo, Noemí Rebollo, José Germán Sánchez-Hernández, Aranzazu Zarzuelo-Castañeda
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundTherapeutic drug monitoring (TDM) of voriconazole is recommended for personalizing doses. The objective of this study was to compare the enzyme immunoassay developed by ARKTM Diagnostics Inc. for the quantification of voriconazole adapted to the Architect C4000 autoanalyzer (Abbott®) with ultra-performance liquid chromatography using ultraviolet detector (UPLC-UV) method.MethodsLinearity, precision and accuracy of both methods were validated according to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The limit of quantification (LOQ) of the UPLC-UV method was determined experimentally. Both methods were applied to the analysis of 62 samples from patients. Correlation was evaluated by Passing–Bablok analysis and the concordance by the Bland–Altman method. Dosage recommendations were generated; the discordances according to the technique were evaluated.ResultsAll validation parameters determined for UPLC-UV met the criteria set out and LOQ of 0.1 μg/mL was established. However, when the enzyme immunoassay was used to determine concentrations ≤1 µg/mL, CVs were>20%.A linear correlation between both methods was found. However, an overestimation of immunoassay (systematic error of 0.39 μg/mL) was detected. In 11.3% of the samples, the differences in concentrations when they were determined by different techniques would imply a different therapeutic regime. These samples had concentrations close to 1 μg/mL.ConclusionAlthough both techniques can be used for TDM of voriconazole, when a value close to the lower limit of the therapeutic range is determined by the ARKTM immunoassay, it would be better to verify the result by a non-automated technique to avoid possible underdosing.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-09-04T08:16:13Z
      DOI: 10.1177/00045632211041887
       
  • Reducing the number of unnecessary laboratory tests within hospital
           through the use of educational interventions

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      Authors: Michael Thurm, Helen Craggs, Merlin Watts, Anthony Brooks
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThe growing number of laboratory investigation requests is placing an increased burden upon NHS resources. Around a quarter of all tests are unnecessary repeats, and almost a third have no impact on patient management. Doctors recognise that tests should only be performed when clinically indicated, but a culture persists of undertaking unnecessary repeat investigations.MethodsA cohort study was undertaken at a district general hospital to observe the impact of introducing educational interventions in the form of a poster and a series of educational lectures, encouraging clinicians to consider whether an investigation was clinically indicated. Data was collected from nine different sites across the hospital run by different medical teams regarding the number of tests undertaken and the impact on patient care.ResultsData from over 13,000 tests and over 2000 patients was analysed from nine different sites across the hospital. There was a significant reduction (33%, p = 0.0001) in the number of blood tests performed. This reduction in testing saved £7006 over the course of 1 month, in addition to other benefits. There was a reduction in testing in eight out of the nine sites in which the study was undertaken, demonstrating good generalisability of results. There was no significant increase in length of admission or mortality.ConclusionEducational interventions to doctors have a significant and safe impact in reducing the number of unnecessary investigations, providing cost saving benefits to the NHS.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-09-01T11:14:28Z
      DOI: 10.1177/00045632211040670
       
  • Lithium heparin interference in the Abbott enzymatic creatinine assay: the
           significance of under-filled tubes

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      Authors: Maria Squires, Helen Wise, Heather Holmes, Katie Hadfield
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundSpuriously high results using the Abbott Architect enzymatic creatinine assay were noted to be particularly associated with very small sample volumes. This led us to query the effect of under-filling lithium heparin tubes on the measured enzymatic creatinine result.MethodsBlood was provided by 5 laboratory personnel and then decanted into 5 x1.2 mL Sarstedt S-Monovette tubes, giving final blood volumes of 200, 400, 600, 800 and 1200 μL. Plasma was analysed using Abbott Architect Jaffe, enzymatic creatinine, Beckman Coulter (AU500) enzymatic creatinine and Roche (Cobas c702) enzymatic creatinine assays. Saline was also added to Sarstedt 1.2 mL and Teklab 2 mL tubes and analysed using the Abbott Jaffe and enzymatic creatinine methods.ResultsIncreasing degrees of under-fill were associated with greater over-estimation of creatinine using the Abbott enzymatic assay, but no difference was noted using Jaffe methodology on the same platform or enzymatic assays provided by Roche or Beckman. On average, creatinine was 40.6% (+27.7 μmol/L) higher when only 200 μL of blood was present in the tube. Small volumes of saline added to lithium heparin tubes measured significant creatinine concentrations using the Abbott enzymatic method.ConclusionsLithium heparin directly interferes in the Abbott Architect enzymatic creatinine assay. Under-filling lithium heparin tubes can lead to clinically significant over-estimation of creatinine results by this assay. Users of this assay should be aware of the potential for spurious results in small sample volumes collected into lithium heparin tubes and implement robust procedures for identifying and reporting results on these samples.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-31T09:49:42Z
      DOI: 10.1177/00045632211040673
       
  • Tumour markers in prostate cancer: The post-prostate-specific antigen era

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      Authors: Manuel M Garrido, Rui M Bernardino, José C Marta, Stefan Holdenrieder, João T Guimarães
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      Although prostate-specific antigen-based prostate cancer screening had a positive impact in reducing prostate cancer mortality, it also led to overdiagnosis, overtreatment and a significant number of unnecessary biopsies. In the post-prostate-specific antigen era, new biomarkers have emerged that can complement the information given by prostate-specific antigen, towards a better cancer diagnostic specificity, and also allowing a better estimate of the aggressiveness of the disease and its clinical outcome. That means those markers have the potential to assist the clinician in the decision-making processes, such as whether or not to perform a biopsy, and to make the best treatment choice among the new therapeutic options available, including active surveillance in lower risk disease. In this article, we will review several of those more recent diagnostic markers (4Kscore®, [-2]proPSA and Prostate Health Index, SelectMDx®, ConfirmMDx®, Progensa® Prostate Cancer Antigen 3, Mi-Prostate Score, ExoDx™ Prostate Test, the Stockholm3 test and ERSPC risk calculators) and prognostic markers (OncotypeDX® Genomic Prostate Score, Prolaris®, Decipher® and ProMark®). We will also address some new liquid biopsy approaches – circulating tumour cells and cell-free DNA – with a potential role in metastatic castration-resistant prostate cancer and will briefly give some future perspectives, mostly outlooking epigenetic markers.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-31T09:28:17Z
      DOI: 10.1177/00045632211041890
       
  • LC-MS/MS the First 20 years: A Personal View

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      Authors: Brian G Keevil
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-28T02:32:56Z
      DOI: 10.1177/00045632211040059
       
  • A rapid liquid chromatography-tandem mass spectrometry method for the
           analysis of urinary 5-hydroxyindoleacetic acid (5-HIAA) that incorporates
           a 13C-labelled internal standard

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      Authors: Kirsten M Grant, Craig Livie, Karen Smith, Chui Ha Leung, Susan Johnston
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundUrinary 5-hydroxyindoleacetic acid (5-HIAA) is a first-line investigation for gastrointestinal neuroendocrine tumours that secrete serotonin. It also has clinical utility for monitoring disease progression and therapeutic response.AimTo develop and validate a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for urinary 5-hydroxyindoleacetic acid that incorporates a supported liquid extraction and 13C-labelled internal standard.MethodsSamples were diluted in ammonium acetate containing a 13C-labelled internal standard (5-hydroxyindole-3a,4,5,6,7,7a-13C6-3-acetic acid). Supported liquid extraction was performed followed by chromatographic separation using the 2.1 × 30 mm CORTECS® UPLC® T3 column. Mass spectrometry detection (Waters Xevo TQ-XS) was performed in electrospray positive mode using the transitions 192.3 > 146.4 m/z (quantifier) and 192.3 > 118.4 m/z (qualifier) for 5-hydroxyindoleacetic acid and 198.2 > 152.4 m/z for 13C-5-HIAA.ResultsA well-defined 5-hydroxyindoleacetic acid peak was observed at 0.8 min with a run time of 2.4 min. The assay was linear (r2 > 0.99) to 382 µmol/L, with a lower limit of quantification of 5.3 µmol/L (CV
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-14T07:39:11Z
      DOI: 10.1177/00045632211038021
       
  • Clinical performance of the Elecsys® anti-SARS-CoV-2 combined in an
           algorithm with two specific anti-IgG immunoassays for the evaluation of
           the serological response of patients with COVID-19 in a population with a
           high prevalence of infection

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      Authors: Xavier Gabaldó-Barrios, Simona Iftimie, Anna Hernández-Aguilera, Isabel Pujol, Frederic Ballester, Luis Fernández, Sara Cladellas, Antoni Castro, Jorge Joven, Jordi Camps, Josep M Simó
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundAnti-SARS-CoV-2 antibodies have been used in the study of the immune response in infected patients. However, differences in sensitivity and specificity have been reported, depending on the method of analysis. The aim of the present study was to evaluate the diagnostic accuracy of an algorithm in which a high-throughput automated assay for total antibodies was used for screening and two semi-automated IgG-specific methods were used to confirm the results, and also to correlate the analytical results with the clinical data and the time elapsed since infection.MethodsWe studied 306 patients, some hospitalized and some outpatients, belonging to a population with a high prevalence of COVID-19. One-hundred and ten patients were classified as SARS-CoV-2 negative and 196 as positive by polymerase chain reaction.ResultsThe algorithm and automated assay alone had a specificity and a positive predictive value of 100%, although the sensitivity and negative predictive value of the algorithm was higher. Both methods showed a good sensitivity from day 11 of the onset of symptoms in asymptomatic and symptomatic patients. The absorbance of the total antibodies was significantly higher in severely symptomatic than in asymptomatic or mildly symptomatic patients, which suggests the antibody level was higher. We found 15 patients who did not present seroconversion at 12 days from the onset of symptoms or the first polymerase chain reaction test.ConclusionThis study highlights the proper functioning of algorithms in the diagnosis of the immune response to COVID-19, which can help to define testing strategies against this disease.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-11T11:29:57Z
      DOI: 10.1177/00045632211038038
       
  • Repeat measurements on patient samples identifies unpredictable and poorly
           reproducible cardiac troponin results with a high-sensitivity cardiac
           troponin assay

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      Authors: Simone Drummond, Ching-Tong Mark, Nadia Caruso, Lorna Clark, Peter A Kavsak
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-11T11:29:32Z
      DOI: 10.1177/00045632211035804
       
  • Serum GP88 as a predictive biomarker for hepatocellular carcinoma in
           patients with viral hepatitis C after direct-acting antiviral agents

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      Authors: Hidekazu Ishida, Masao Takemura, Atsushi Suetsugu, Takafumi Naiki, Takuji Tanaka, Tomita Eiichi, Ginette Serrero, Hidetoshi Matsunami, Yasuko Yamamoto, Kuniaki Saito
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundProgranulin (GP88) is an 88-kDa glycoprotein growth factor with important biological effects in tumorigenesis and tumour survival. We investigated the usefulness of measuring serum GP88 concentrations as a predictive biomarker for hepatocellular carcinoma in patients with viral hepatitis C after treatment with direct-acting antiviral agents. MethodsWe measured the serum GP88 concentrations by using a sandwich enzyme-linked immunoassay from 67 healthy control subjects and 29 patients (20 patients who did not develop hepatocellular carcinoma and 9 patients who developed hepatocellular carcinoma after treatment) with viral hepatitis C after treatment with asunaprevir and daclatasvir.ResultsThe serum GP88 concentrations of patients with chronic hepatitis C prior to antiviral treatment were significantly higher than those of healthy control subjects. After antiviral treatment, the serum GP88 concentrations of patients who eventually developed hepatocellular carcinoma were significantly higher than those who did not develop hepatocellular carcinoma. The changes in the serum GP88 concentrations before and after treatment in patients who developed hepatocellular carcinoma were significantly lower than those in patients who did not develop hepatocellular carcinoma. The cumulative incidence of hepatocellular carcinoma was significantly higher in either patients with high serum GP88 concentrations after treatment or those with small changes of serum GP88 concentrations pre- and post-treatment.ConclusionsSustained high concentrations of serum GP88 in patients treated with direct-acting antiviral agents are correlated with the risk of developing hepatocellular carcinoma.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-11T11:29:02Z
      DOI: 10.1177/00045632211036723
       
  • Monitoring motherhood: Monitoring and optimizing glycaemia in women with
           pre-existing diabetes in pregnancy

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      Authors: Claire L Meek
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      Despite recent advances in care, women with diabetes in pregnancy are still at increased risk of multiple pregnancy complications. Offspring exposed to hyperglycaemia in utero also experience long-term health sequelae, affecting neurocognitive and cardiometabolic status. Many of these adverse consequences can be prevented or ameliorated with good medical care, specifically to optimize glycaemic control. The accurate assessment of glycaemia in pregnancy is therefore vital to safeguard the health of mother and child. However, there is no consensus about the best method of monitoring glycaemic control in pregnancy. Short-term changes in insulin dosage and lifestyle, with altered appetite, insulin sensitivity and red cell turnover create difficulties in interpretation of standard laboratory measures such as HbA1c. The ideal marker would provide short-term feedback on daily or weekly glycaemic control, with additional capability to predict pregnancies at high risk of suboptimal outcomes. Several novel biochemical markers are available which allow assessment of dynamic changes in glycaemia over weeks rather than months. Continuous glucose monitoring devices have advanced in accuracy and provide new opportunities for robust assessment of glycaemia in pregnancy. Recent work from the continuous glucose monitoring in pregnant women with type 1 diabetes trial (CONCEPTT) has provided information about the ability of different markers of glycaemia to predict pregnancy outcomes.The aim of this review is to summarize the care for women with pre-existing diabetes in pregnancy and to highlight the important role of glycaemic monitoring in pregnancy.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-08-03T01:23:13Z
      DOI: 10.1177/00045632211035815
       
  • A rapid LC-MS/MS assay for the measurement of serum methotrexate in
           patients who have received high doses for chemotherapy

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      Authors: Malcolm P McTaggart, Brain G Keevil
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundMethotrexate is used in high doses to treat a number of cancers, particularly certain haematological malignancies. Monitoring of serum methotrexate concentration is important due to the potential toxicity of methotrexate and the variation in methotrexate pharmacokinetics in different patients on the same treatment regimen.ObjectiveTo develop a rapid liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for monitoring serum methotrexate in patients on high-dose chemotherapy.MethodIsotopically labelled internal standard was added to sample prior to protein precipitation with methanol. Diluted supernatant was injected into a Waters Acquity UPLC system linked to a TQS-Micro mass spectrometer. Separation by chromatography was achieved with a Waters Phenyl Vanguard with a retention time of approximately 0.5 min. The quantifier and qualifier transitions for methotrexate were 455.2>134.1 and 455.2>175.2, respectively.ResultsMean recovery was 111% for three different concentrations of methotrexate spiked into seven different patient samples, with ion suppression
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-16T07:36:41Z
      DOI: 10.1177/00045632211031284
       
  • Identifying mislabelled samples: Machine learning models exceed human
           performance

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      Authors: Christopher-John Farrell
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundIt is difficult for clinical laboratories to identify samples that are labelled with the details of an incorrect patient. Many laboratories screen for these errors with delta checks, with final decision-making based on manual review of results by laboratory staff. Machine learning models have been shown to outperform delta checks for identifying these errors. However, a comparison of machine learning models to human-level performance has not yet been made.MethodsDeidentified data for current and previous (within seven days) electrolytes, urea and creatinine results was used in the computer simulation of mislabelled samples. Eight different machine learning models were developed on 127,256 sets of results using different algorithms: artificial neural network, extreme gradient boosting, support vector machine, random forest, logistic regression, k-nearest neighbours and two decision trees (one complex and one simple). A separate test data-set (n = 14,140) was used to evaluate the performance of these models as well as laboratory staff volunteers, who manually reviewed a random subset of this data (n = 500).ResultsThe best performing machine learning model was the artificial neural network (92.1% accuracy), with the simple decision tree demonstrating the poorest accuracy (86.5%). The accuracy of laboratory staff for identifying mislabelled samples was 77.8%.ConclusionsThe results of this preliminary investigation suggest that even relatively simple machine learning models can exceed human performance for identifying mislabelled samples. Machine learning techniques should be considered for implementation in clinical laboratories to assist with error identification.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-16T07:36:08Z
      DOI: 10.1177/00045632211032991
       
  • Reducing neonatal phlebotomy blood losses through the accurate calculation
           of minimum test volume requirements

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      Authors: Eric S Kilpatrick, Elicia L Ginn, Ben H Lee
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundRepeated phlebotomy for laboratory diagnostic testing is a known cause of iatrogenic anaemia and in critically ill neonates often leads to blood transfusion being required. This study has developed a spreadsheet clinical decision support tool to allow neonatal staff to determine the true minimum blood volume required to analyse groups of blood tests and modelled its potential benefit compared with the existing system in use.MethodsThe tool calculates the minimum blood volume accounting for novel factors including the current patient haematocrit for plasma/serum samples, instrument minimum test and dead volumes (including those where shared) and sharing of samples within/between laboratory departments. A year of neonatal unit laboratory requests were examined comparing the volumes and containers of blood recommended by the hospital information system with both the amount actually collected by staff and that recommended by the tool.ResultsA total of 463 patients had 8481 blood draws for 23,899 tests or test profiles over the year. The hospital information system recommended collecting 11,222 mL of blood into 18,509 containers, while 17,734 containers were actually received (10,717 mL if fully filled). The tool recommended collecting 4915 mL of blood into 15,549 containers.ConclusionsThis tool allows neonatal intensive care unit staff to objectively determine the minimum blood volume required for a combination of tests and is generalizable between laboratory instruments. Compared with the hospital information system, use of the minimum blood volume clinical decision support tool could maximally reduce the volume of blood collected from this neonatal unit by more than a half. Neonatal intensive care unit staff had apparently already gone some way to determining their own minimum volumes required.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-14T06:05:50Z
      DOI: 10.1177/00045632211030953
       
  • Paired sensitivity analysis of four SARS-CoV-2 serological immunoassays in
           a longitudinal cohort of convalescent hospital staff

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      Authors: Marcus Sim, Christopher Cockcroft, Denise Darby, Clare R Ellis, Adrian Heaps, Jonathan Scargill, Tomaz Garcez
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundSARS-CoV-2 serological testing has seen extensive academic and clinical use from investigating correlates of immunity to seroprevalence, convalescent plasma and vaccine trials. Interpretation of these studies will depend on robust validation of the longitudinal sensitivities of these assays, especially in the context of mild disease which makes up the majority of the Coronavirus Disease 2019 (COVID-19) caseload.MethodsHospital staff (n = 94) returning to work following polymerase chain reaction confirmed COVID-19 were offered antibody testing to assist with laboratory verification. Initial specimens were collected at median 29 days post-symptom onset and run on the Roche, Abbott, Siemens and DiaSorin platforms. Re-sampling occurred at median 142 days from a subset of the initial cohort (n = 62) that had volunteered to provide further serum samples to assist in longitudinal sensitivity analysis. Samples that were not run across all four platforms were excluded from analysis.ResultsComparative sensitivity analysis was conducted on 89/94 of the initial specimens and 55/62 of the repeat specimens. Sensitivity at initial sampling ranged from 78 to 87% across platforms. At re-sampling, sensitivities were: 100% (Roche), 45% (Abbott), 100% (Siemens), and 80% (DiaSorin). Paired analysis using the longitudinal cohort (n = 55) demonstrated stable or increasing median assay values on three platforms, with a clear reduction seen only on the Abbott platform (4.78 to 1.34) with corresponding sensitivity drop-off (81.8% to 45.4%).ConclusionThe Abbott assay demonstrated sensitivity drop-off and decrease in median assay signal below detection threshold at four to five months. This has implications on the interpretation and design of future studies.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-14T06:05:33Z
      DOI: 10.1177/00045632211030957
       
  • Analytical characterization and clinical performance evaluation of a new
           point-of-care testing system for high-sensitivity cardiac troponin I assay
           

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      Authors: Rui Zhang, Yueyu Hong, Jie Shi, Rui Zhao, Yichuan Song, Ziyao Li, Qingtao Wang
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundWe aimed to evaluate the analytical performance and clinical diagnostic accuracy of the SuperFlex point-of-care testing (POCT) high-sensitivity cardiac troponin I (hs-cTnI) assay system.MethodThe imprecision, the limit of blank, the limit of detection, the limit of quantitation, linearity and comparability were assessed as per the Clinical and Laboratory Standards Institute guidelines. Also, the 99th-percentile reference value and diagnostic accuracy were evaluated.ResultsThe reproducibility and total imprecision were 1.52–1.92% and 2.69–2.92%, respectively. Limit of blank and limit of detection were 1 ng/L and 1.8 ng/L, respectively, and limit of quantitation was 12 ng/L at 10% coefficient of variation (CV). The results met the requirements of linearity, and the correlation coefficient was 0.996. The SuperFlex POCT results had good agreement with those obtained by the Siemens Advia 2400. The CV% was 7.24% at the 99th percentile concentration (p99th) of 25.6 ng/L (95% confidence interval: 22.0–33.3 ng/L) from 620 healthy subjects. The sex-partitioned CV% and p99th were 7.15% at 27 ng/L (males; n = 308) and 7.35% at 24 ng/L (females; n = 312), respectively (P 
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-09T04:59:44Z
      DOI: 10.1177/00045632211027604
       
  • A rare case of persistent hyperkalaemia

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      Authors: Thomas Lewis, Gareth Roberts, Soha Zouwail
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      Hyperkalaemia is a common biochemical finding that can allude to preanalytical or truly pathological causes. Here, we present a case of a 41-year-old female patient who has regularly presented with incidences of isolated hyperkalaemia since 2012, with otherwise normal renal function and no other associated symptoms. Investigations into the patient’s family history revealed similar biochemical findings in her brother and eldest son. Familial causes of hyperkalaemia were investigated and an eventual diagnosis of pseudo-hypoaldosteronism type 2C was established. This is a rare congenital renal tubular disorder – also known as Gordon syndrome – that can cause a characteristic triad of symptoms that include hyperkalaemia, metabolic acidosis and hypertension. The presence and severity of each of these symptoms is dependent upon the disease-causing mutation that occurs in WNK4, WNK1, CUL3 or KLHL3 genes. These mutations alter the regulation of sodium/chloride co-transporter (NCC) expression on the luminal membrane of the principal cells of the distal convoluted tubule, disrupting normal homeostatic regulation of electrolyte reabsorption and excretion. The resolution for treating this condition is the administration of a thiazide diuretic, which directly counteracts the effects of NCC co-transporter overexpression and consequently aims to resolve the symptoms that arise as a result of this aberrant signalling. The case described here uniquely presents an extremely rare pathogenic variant in the conserved acidic motif of WNK1 resulting in a clear electrolyte phenotype with no hypertension.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-05T04:53:36Z
      DOI: 10.1177/00045632211028614
       
  • A survey of the reactivity of in vitro diagnostic bilirubin reagents
           developed in Japan using artificially prepared bilirubin materials: A
           comparison of synthetic delta, unconjugated, and taurine-conjugated
           bilirubin

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      Authors: Sachiko Kiuchi, Hiroshi Ihara, Susumu Osawa, Midori Ishibashi, Kiyoko Kinpara, Kazuko Ohtake, Takehisa Ida, Yoshinori Miura, Yoshiyuki Fujimura, Shigeru Ueda, Yuuki Hirano, Kensuke Watahiki, Daiichiro Takada, Akihiro Shinzaki, Kazuhito Tanimoto, Hiroshi Adachi, Tetsuya Nejime, Masayuki Totani, Susumu Itoh
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundIn vitro diagnostic bilirubin reagents based on oxidation with bilirubin oxidase or vanadic acid for total and direct-reacting bilirubin are widely used in Japan; however, their reactivity to unconjugated and conjugated bilirubin and delta bilirubin has not been completely disclosed by manufacturers. We used artificially prepared bilirubin materials to investigate the reactivity with four in vitro diagnostic bilirubin reagents.MethodsPorcine unconjugated bilirubin solution, chemically synthesized ditaurobilirubin solution, and chemically synthesized delta bilirubin solution were used as surrogates of naturally occurring unconjugated bilirubin, conjugated bilirubin, and delta bilirubin, respectively. The total bilirubin and direct-reacting bilirubin concentrations were measured by three bilirubin oxidase methods and one vanadic acid method, and the observed concentrations were compared with those obtained by the diazo-based reference measurement procedure.ResultsThe unconjugated bilirubin and delta bilirubin concentrations were similar when any of the four in vitro diagnostic bilirubin reagents were used during total bilirubin measurement. This was consistent with reference measurement procedure and exhibited a converged inter-method variation. Compared with reference measurement procedure, significantly low ditaurobilirubin concentrations were observed by the in vitro diagnostic bilirubin reagents despite the converged inter-method variation. In delta bilirubin measurement, some reagents reacted doubtfully with unconjugated bilirubin, while showed lower ditaurobilirubin concentrations than its corresponding total bilirubin concentration. Reactivity with delta bilirubin was different for each method including reference measurement procedure. Some reagents were developed to react less with delta bilirubin and others to strongly react with delta bilirubin.ConclusionsWe revealed the reactivity of IVD-TB and IVD-DB reagents to artificially prepared bilirubin materials, and their consistency with reference measurement procedure. The delta bilirubin data results vary depending on the reagents used.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-05T04:53:17Z
      DOI: 10.1177/00045632211026699
       
  • The effect of paraprotein polymerisation on quantitation by capillary zone
           electrophoresis and Hevylite®

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      Authors: Helen Valentine, Anne Dawnay
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      ObjectivesUp to 3% of patients with monoclonal gammopathies have multiple serum paraproteins. This article investigates whether multiple isotype-matched paraproteins, as seen on capillary zone electrophoresis, are truly biclonal.MethodsSerum samples containing multiple isotype-matched paraproteins were treated with the reducing agent dithiothreitol, and capillary zone electrophoresis was performed pre- and post-treatment. Band resolution and effect of resolution on quantitation of paraprotein burden were assessed. The Hevylite® turbidimetric assay was also evaluated for ability to quantify such paraproteins.ResultsAmong patients with biclonal isotype-matched paraproteins, 23/24 (96%) IgA paraproteins resolved into a single band following treatment with dithiothreitol compared with only 1/12 (8%) IgG paraproteins. Daratumumab therapy accounted for the second band in 5/9 non-resolving IgGκ paraproteins. Where initially quantified as a single IgA ‘complex’ (multiple bands in close proximity), the single postdithiothreitol band averaged 2.8 g/L less (P
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-05T04:53:01Z
      DOI: 10.1177/00045632211029327
       
  • Uninterpretable cerebrospinal fluid absorbance scans caused by antibiotic
           therapy

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      Authors: Jan Miller
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThe revised national guidelines for analysis of cerebrospinal fluid for bilirubin in suspected subarachnoid haemorrhage (UK) provide an objective means of assessing cerebrospinal fluid samples to determine the risk of subarachnoid haemorrhage. The guidelines are intended for general use, but samples rendered uninterpretable due to the presence of the antibiotic doxycycline have been described. Here, further cases of antibiotic-based interference, and their implications, are presented.MethodsAn archival search of cerebrospinal fluid spectra performed at Hallands County Hospital Halmstad was performed for the years 2011 and 2016–2019 in an attempt to locate instances of interference. Each case of suspected interference was further investigated with in vitro reproduction experiments as a means of confirmation and assessment of potential clinical impact.ResultsA total of 10 cases of cerebrospinal fluid curve interference were discovered: six due to doxycycline, three due to metronidazole and one due to tetracycline. Interference caused by the tetracycline class was revealed through in vitro experimentation to cause an apparent decrease in the sample’s net bilirubin absorbance; the presence of xanthochromia on visual inspection was, however, conserved.ConclusionsThe problem of cerebrospinal fluid absorbance curve interference might be more common than previously suspected. Due to the potential net bilirubin absorbance-lowering effect of tetracyclines, the author recommends visual examination of cerebrospinal fluid samples in every case.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-07-02T06:33:47Z
      DOI: 10.1177/00045632211027612
       
  • Serum carbohydrate antigen 72-4 concentrations decrease with age in
           females but not in males in Beijing, China

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      Authors: Tongmei Duan, Xun Chen, Jing Wu, Ronghai Li, Huijuan Guo, Juan Du, Jie Guo
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      ObjectiveCarbohydrate antigen 72-4 (CA72-4) is widely used in the diagnosis and monitoring of many cancers. However, there are few studies on the differences of CA72-4 concentrations in terms of age and gender.MethodsA total of 10,957 healthy subjects were divided into two groups according to gender and three age groups. The serum CA72-4 were detected. Statistical analysis was performed by SPSS.ResultsThe CA72-4 concentration in female group was significantly higher than that in male group. The concentration of CA72-4 gradually decreased with age. Compared with the age>60 group, the CA72-4 concentrations were increased in the age 46–60 group and 16–45 group (P>0.05, respectively). To better observe the age difference, the age 16–45 and 46–60 groups were combined into the age 16–60 group. In comparison to the age>60 group, the CA72-4 concentration of age 16–60 group was significantly increased (P = 0.000). In the age>60 group, there was no difference between genders. Nevertheless, the difference between the sexes in the age 16–60 group was significant (P = 0.023).ConclusionsThe reference interval of CA72-4 for local healthy population was established. CA72-4 concentrations gradually decreased with the increase of age, and CA72-4 concentration in females aged 16–60 years (0–18.0 U/mL) was higher than in males (0–14.5 U/mL); however, there was no gender difference in the age group above 60 years old (0–14.5 U/mL). Moreover, in male CA72-4 there was no significant difference among all age groups, while the potential mechanism of female changes with age needs further study.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-30T04:37:36Z
      DOI: 10.1177/00045632211026961
       
  • Authors’ reply to ‘Is there a role for C-reactive protein during and
           after labour'’

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      Authors: Caroline M Joyce, Paula M O’Shea, Keelin O’Donoghue
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-08T05:45:15Z
      DOI: 10.1177/00045632211020774
       
  • Is there a role for C-reactive protein during and after labour'

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      Authors: Samuel Dockree, Jennifer Brook, Brian Shine, Tim James, Manu Vatish
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-08T05:44:48Z
      DOI: 10.1177/00045632211018710
       
  • Participant case marks for identical comments in UK-NEQAS for
           interpretative comments have good precision

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      Authors: Tejas Kalaria, Clare Ford, Rousseau Gama
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-29T11:17:26Z
      DOI: 10.1177/00045632211016025
       
  • Age- and sex-related reference interval for free thyroxine: An indirect
           approach

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      Authors: Ruggero Dittadi, Paolo Carraro
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-29T11:17:02Z
      DOI: 10.1177/00045632211020027
       
  • Reportable range of quantitative assays for SARS-CoV-2 antibodies
           determination: An overlooked issue'

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      Authors: Ruggero Dittadi, Isabella Bertoli, Paolo Carraro
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-29T11:17:01Z
      DOI: 10.1177/00045632211020047
       
  • Use of eGFR instead of creatinine in exclusion criteria for derivation of
           calcium adjustment equation

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      Authors: N Jassam, D Turnock, JH Barth
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-21T12:34:43Z
      DOI: 10.1177/00045632211016504
       
  • Serum biomarkers for prediction of mortality in patients with COVID-19

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      Authors: Rohit S Loomba, Enrique G Villarreal, Juan S Farias, Gaurav Aggarwal, Saurabh Aggarwal, Saul Flores
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThere is limited information regarding the role of biomarker levels at predicting mortality in patients with the coronavirus disease (COVID-19) pandemic. The purpose of this study is to determine the differences in serum biomarker levels in adults with COVID-19 who survived hospitalization from those who did not.MethodsA comprehensive search was completed on PubMed, EMBASE and Cochrane libraries to identify studies of interest. Endpoints of interest were blood counts, hepatic function test, acute phase reactants, cytokines and cardiac biomarkers.ResultsA total of 10 studies with 1584 patients were included in the pooled analyses. Biomarkers that were noted to be significantly higher in those who died from coronavirus disease included: white blood cell count, neutrophil count, C-reactive protein, high sensitivity C-reactive protein, procalcitonin, ferritin, D-dimer, interleukin-6, lactate dehydrogenase, creatine kinase, prothrombin time, aspartate aminotransferase, alanine aminotransferase, total bilirubin and creatinine. Lymphocyte count, platelet count and albumin were significantly lower in patients who died.ConclusionThis pooled analysis of 10 studies including 1584 patients identified significant differences in biomarkers on admission in patients who survived from those who did not. Further research is needed to develop risk stratification models to help with judicious use of limited health-care resources.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-15T02:10:20Z
      DOI: 10.1177/00045632211014244
       
  • Health economic evaluations of medical tests: Translating laboratory
           information into value – A case study example

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      Authors: Paul Jülicher, Maurice O’Kane, Christopher P Price, Robert Christenson, Andrew St John
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      Health-care providers and funders are focused on identifying value in all their services and that includes laboratories. This means that in order to gain a share of scarce resources, laboratory professionals must also understand and assess the value of tests and that includes their economic impact. This can be assessed using health economic modelling tools which, when used in conjunction with a detailed value proposition for the test, can translate laboratory information into value. While a variety of health economic assessment tools are available, this review will focus on the use of decision analytic models which essentially compare the outcomes from pathways with and without the new test, the value of which is being assessed. A step-by-step framework is provided to guide laboratory professionals through the essential steps of conducting the evaluation. Initial steps include mapping the clinical pathway, understanding the goal of the evaluation, identifying the key stakeholders and their needs and determining a suitable analytical model. Following collection of the actual data, the validity of the model must be checked, and the robustness of the outcomes tested through sensitivity analysis. The last step is to translate the findings into measures of value which can then inform appropriate decisions by the stakeholders. This review of basic health economic modelling should enable laboratory professionals to have an understanding of how modelling can be applied to tests in their own environment and help deliver their potential value.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-15T02:09:44Z
      DOI: 10.1177/00045632211013852
       
  • Prevalence of paraprotein interference in three clinical chemistry
           analytes in a routine biochemistry laboratory

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      Authors: Lindsay Graham, Dinesh Talwar, Neil R Syme
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-05T04:49:25Z
      DOI: 10.1177/00045632211013862
       
  • Authors’ reply to ‘Plasma clearance and lipaemic index of lipid
           emulsion used for lipid emulsion treatment’

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      Authors: Jun Guan Tan, Moh Sim Wong
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-13T05:08:48Z
      DOI: 10.1177/00045632211007158
       
  • SARS-CoV-2 (Covid-19): A short update on molecular biochemistry,
           pathology, diagnosis and therapeutic strategies

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      Authors: Adel AA Ismail
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      The ongoing coronavirus (covid-19) pandemic highlights the need for global scientific cooperation to advance our understanding of the immunological, molecular and biochemical mechanisms causing infection by this virus. Better understanding of key processes has allowed the development of vaccines in record time, and of agents with the potential to treat and neutralize current and future coronavirus outbreaks. To date, clinically effective agents for prevention and treatment of covid-19 infections are limited. This review provides a brief synopsis regarding the molecular biology, pathology and laboratory tests commonly used in the diagnosis and prognosis of covid-19, as well as the development of vaccines and therapeutic strategies to manage its current and future mutations.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-02-11T04:59:39Z
      DOI: 10.1177/0004563221992390
       
  • Urolithiasis: Don’t forget the rarities

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      Authors: EJ Kim, MA Crook
      First page: 392
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-28T04:39:23Z
      DOI: 10.1177/00045632211018711
       
  • Negative values and variance functions: Implications for statistical
           analysis

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      Authors: William A Sadler
      First page: 395
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      When reporting concentrations of substances in biological specimens it has been virtually universal practice to suppress negative results, initially by left-censoring negative results to zero and more recently by left-censoring to values such as limit of blank, limit of detection or even limit of quantification. Negative concentrations are obviously nonsensical and current reporting practices place proper emphasis on assisting the clinician. However, it is easily overlooked that negative concentrations are merely artefacts of data reduction and while adjusting them is sensible clinical practice there are potentially adverse consequences for statistical analysis, in particular for those parametric summaries and analyses which rely on reliable estimates of low-end uncertainty. This article puts a case for the availability of negative results, describes complications with respect to estimating variance functions and discusses practical workarounds.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-01-12T04:31:56Z
      DOI: 10.1177/0004563220985546
       
  • HPLC with spectrophotometric or mass spectrometric detection for
           quantifying very-long chain fatty acids in human plasma and its
           association with cardiac risk factors

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      Authors: Rojeet Shrestha, Zhen Chen, Zijun Gao, Yifan Chen, Emiko Okada, Shigekazu Ukawa, Takafumi Nakagawa, Koshi Nakamura, Akiko Tamakoshi, Hitoshi Chiba, Shu-Ping Hui
      First page: 400
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundWe developed and compared two liquid chromatography methods, one with UV/Visible spectrophotometric detection (HPLC) and the other with mass spectrometric detection (LC-MS), for quantifying very-long chain fatty acids (VLCFA) in human plasma. Association of VLCFA with various cardiovascular risk factors were evaluated.MethodFasting blood samples were collected from 541 human volunteers (242 men and 299 women; mean age ±SD, 58.9 ± 12.4 years), including 429 and 112 individuals with and without hypertriglyceridemia, respectively. Esterified VLCFA were saponified and derivatized with 2-nitrophenylhydrazine. Separation of VLCFA species was achieved with C4 Mightysil column (HPLC) and Ascentis Express Phenyl-Hexyl column (LC-MS) followed by spectrophotometric and selected-reaction monitoring mode of mass spectrometric detection, respectively.ResultsThe HPLC assay of VLCFA was precise with intra-assay imprecision of 2.5% to 6.9% and inter-assay imprecision of 3.2% to 9.5%. Moreover, there was an excellent correlation (r > 0.96) between HPLC and LC-MS methods. The 95 percentile reference intervals (RI; upper limit) of VLCFA were determined to be 41.3 µmol/L in healthy volunteers. Plasma VLCFA were significantly correlated with triglycerides (Spearman’s ρ = 0.306, P 
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-12T05:12:01Z
      DOI: 10.1177/00045632211007157
       
  • The use of whole blood capillary samples to measure 15 analytes for a
           home-collect biochemistry service during the SARS-CoV-2 pandemic: A
           proposed model from North West London Pathology

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      Authors: Saleem Ansari, Mariana Abdel-Malek, Julia Kenkre, Sirazum M Choudhury, Sophie Barnes, Shivani Misra, Tricia Tan, Jaimini Cegla
      First page: 411
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThe COVID-19 pandemic has drastically changed the delivery of secondary care services. Self-collection of capillary blood at home can facilitate the monitoring of patients with chronic disease to support virtual clinics while mitigating the risk of SARS-CoV-2 infection and transmission.ObjectiveTo investigate the comparability of whole blood capillary and plasma venous samples for 15 routinely used biochemical analytes and to develop and pilot a user-friendly home-collection kit to support virtual outpatient clinical services.MethodsTo investigate the comparability of whole blood capillary and plasma venous samples for 15 routinely requested biochemical analytes, simultaneous samples of venous and capillary blood were collected in EDTA and lithium-heparin plasma separation tubes that were of 4–6 mL and 400–600 µL draw volume, respectively. Venous samples were analysed within 4 h of collection while capillary samples were kept at ambient temperature for three days until centrifugation and analysis. Analyte results that were comparable between the matrices were then piloted in a feasibility study in three outpatient clinical services.ResultsHbA1c, lipid profile and liver function tests were considered comparable and piloted in the patient feasibility study. The home-collect kit demonstrated good patient usability.ConclusionHome collection of capillary blood could be a clinically-useful tool to deliver virtual care to patients with chronic disease.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-13T05:08:32Z
      DOI: 10.1177/00045632211004995
       
  • An LC-MS/MS assay for analysis of equilibrium angiotensin II in human
           serum

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      Authors: Laura Bernstone, Joanne E Adaway, Brian G Keevil
      First page: 422
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThe current first-line screening test for primary hyperaldosteronism is the plasma aldosterone:renin ratio; however, renin assays have several disadvantages and the ARR is affected by medications and physiological factors. Angiotensin II is a key biologically active hormone in the renin-angiotensin-aldosterone system. It has been suggested that measurement of equilibrium levels of this peptide, involving an in vitro incubation of serum prior to analysis, may provide a better marker of renin-angiotensin-aldosterone system activity than renin.MethodsAn eqAng II LC-MS/MS assay was developed, optimized and validated. Serum samples were incubated at 37°C for 45 min prior to stabilization with cold EDTA solution, solid phase extraction and LC-MS/MS analysis. Stability in whole blood and the effect of cryoactivation were assessed. For comparison to the current screening test, 150 anonymized patients’ samples were analysed for eqAng II, renin activity and aldosterone (all by LC-MS/MS).ResultsThe assay had good precision, minimal bias and acceptable recovery. EqAng II did not change significantly when whole blood samples were stored for up to 72 h, and cryoactivation was only observed for pregnant patients. EqAng II was significantly correlated with renin, and the aldosterone:eqAng II ratio had a strong positive correlation with the aldosterone:renin ratio.ConclusionsAn LC-MS/MS assay for eqAng II has been developed which shows promise as an alternative screening test for primary hyperaldosteronism. Compared to renin assays, it is quicker, simpler and less likely to be affected by anti-hypertensive medications. Further clinical validation in hypertensive patients would be required prior to implementation.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-20T05:01:15Z
      DOI: 10.1177/00045632211008923
       
  • A composite risk model predicts disease progression in early stages of
           COVID-19: A propensity score-matched cohort study

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      Authors: Jianjun Xu, Yang Gao, Shaobo Hu, Suzhen Li, Weimin Wang, Yuzhe Wu, Zhe Su, Xing Zhou, Xiang Cheng, Qichang Zheng
      First page: 434
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundRecently, studies on COVID-19 have focused on the epidemiology of the disease and clinical characteristics of patients, as well as on the risk factors associated with mortality during hospitalization in critical COVID-19 cases. However, few research has been performed on the prediction of disease progression in particular group of patients in the early stages of COVID-19.MethodsThe study included 338 patients with COVID-19 treated at two hospitals in Wuhan, China, from December 2019 to March 2020. Predictors of the progression of COVID-19 from mild to severe stages were selected by the logistic regression analysis.ResultsCOVID-19 progression to severe and critical stages was confirmed in 78 (23.1%) patients. The average value of the neutrophil-to-lymphocyte ratio (NLR) was higher in patients in the disease progression group than in the improvement group. Multivariable logistic regression analysis revealed that elevated NLR, LDH and IL-10 were independent predictors of disease progression. The optimal cut-off value of NLR was 3.75. The values of the area under the curve, reflecting the accuracy of predicting COVID-19 progression by NLR was 0.739 (95%CI: 0.605–0.804). The risk model based on NLR, LDH and IL-10 had the highest area under the ROC curve.ConclusionsThe performed analysis demonstrates that high concentrations of NLR, LDH and IL-10 were independent risk factors for predicting disease progression in patients at the early stage of COVID-19. The risk model combined with NLR, LDH and IL-10 improved the accuracy of the prediction of disease progression in patients in the early stages of COVID-19.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-22T04:50:24Z
      DOI: 10.1177/00045632211011194
       
  • Personalising laboratory medicine in the ‘real world’: Assessing
           clinical utility, by clinical indication, of serum total B12 and
           Active-B12® (holotranscobalamin) in the diagnosis of vitamin B12
           deficiency

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      Authors: Michael J Murphy, Fiona Brandie, Mildred Ebare, Michelle Harrison, Ellie Dow, William A Bartlett, David Craig
      First page: 445
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundAssessing the pre- and post-test probability of disease in the context of routine health care is challenging. We wished to study how test performance parameters relating to clinical utility vary by clinical indication in a ‘real-world’ setting.MethodsThe diagnostic accuracy of serum total B12 and Active-B12® (holotranscobalamin) was evaluated in a primary care population, using serum methylmalonic acid as the reference standard. We used electronic requesting to establish the clinical indication for each request. Routine requests from primary care for serum total B12 were included if creatinine was also measured and estimated glomerular filtration rate was at least 60 mL/min/1.73 m2.ResultsClinical indications included peripheral neuropathy (n = 168), anaemia (n = 168), cognitive decline (n = 125), suspected dietary deficiency (n = 76), other (n = 362). For peripheral neuropathy, the area under the receiver operator curve ± 95% confidence interval (AUC ± CI) was 0.63 (0.54–0.71) (P = 0.002) for total B12 and 0.68 (0.60–0.77) (P 
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-24T04:34:45Z
      DOI: 10.1177/00045632211003605
       
  • Reference values for C-reactive protein and procalcitonin at term
           pregnancy and in the early postnatal period

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      Authors: Caroline M Joyce, Shane Deasy, Hala Abu, Yoke Yin Lim, Paula M O’Shea, Keelin O’Donoghue
      First page: 452
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundEarly recognition of sepsis and prompt treatment improves patient outcome. C-reactive protein is a sensitive marker for tissue damage and inflammation, but procalcitonin has greater specificity for bacterial infection. Limited research exists regarding the use of C-reactive protein and procalcitonin at term pregnancy and the immediate postpartum period.AimThis study sought to define reference values for C-reactive protein and procalcitonin at term and the early postnatal period.MethodsA prospective cross-sectional study was performed in a university teaching hospital. Venous blood was collected from healthy women (n = 196), aged between 19 and 45 years with an uncomplicated singleton pregnancy, at term (37–40 weeks’ gestation) and on day 1 and day 3 postpartum for the measurement of C-reactive protein and procalcitonin.ResultsThe reference population comprised of 189 participants: term pregnancy (n = 51), postpartum day 1 vaginal delivery (n = 70) and caesarean section (n = 38) and day 3 (caesarean section, n = 30). The maximum procalcitonin value at term pregnancy was 0.1 μg/L. On day 1 postpartum, 90% and 86.8% of procalcitonin results for vaginal delivery and caesarean section, respectively, were below the decision-threshold of 0.25 μg/L. The specificity of procalcitonin to rule out infection in the reference population was 91.5%.ConclusionsReference values for procalcitonin were established in a well-characterized population of healthy pregnant women at term and immediately postpartum. The variability of C-reactive protein limits its clinical utility in the assessment of systemic sepsis. Application of the procalcitonin cut-off of 0.25 μg/L in this population will be a valuable adjunct to clinicians ruling out infection in pregnancy and postpartum.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-24T04:34:28Z
      DOI: 10.1177/00045632211005807
       
  • Measurement of vitamin D in dried blood spots stored under different
           temperature conditions

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      Authors: Mads Nybo, Palle N Fruekilde, Karen Andersen-Ranberg
      First page: 461
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundAs part of the Survey of Health, Ageing and Retirement in Europe (SHARE) study, dried blood spot samples were obtained for measurement of potential biological biomarkers, among those vitamin D. Unfortunately, no studies describe the impact of high temperatures on dried blood spot samples and vitamin D measurements.Materials and methodsCapillary samples were collected on dried blood spot cards from 40 outpatients (median age 78 years) along with venous blood samples. To mimic the different environmental and temporal challenges during collection and shipment until final storage in the SHARE study, dried blood spot cards were stored at different temperatures, at time span and with/without freeze-thaw. Vitamin D concentrations in venous plasma samples were measured by conventional immunoassay (on Architect i2000SR), while vitamin D concentrations in dried blood spot samples were measured using LC-MS/MS with a well-described extraction method and with relevant calibration and comparison with a reference method.ResultsVitamin D measured in dried blood spot samples did not differ significantly from venous plasma measurements under the different storage conditions tested. The optimal vitamin D correlation between the two matrices was by storage at either 21°C or 35°C for four days (r = 0.9060 and 0.9026, respectively). Freeze-thaw of the dried blood spot samples did not have any significant effect.ConclusionWe find that vitamin D measured in dried blood spot samples do not differ significantly from venous plasma measurements despite storage at different temperatures and freeze-thaw, which enables the use of dried blood spot in multicentre studies taking place under alternating temperature conditions.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-05T04:49:40Z
      DOI: 10.1177/00045632211013870
       
  • Evaluation of the quick-clotting serum separator tube, VQ-Tube™, for
           clinical chemistry and thyroid hormone assays

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      Authors: Sung Jin Jo, Hyojin Chae, Yong-Wha Lee, Jong Do Seo, Sang Hoon Song, Jehoon Lee
      First page: 468
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThe type of blood collection tube affects specimen quality and laboratory results. Because plasma specimens have a shorter processing time compared with serum specimens, emergency biochemistry tests use plasma. However, serum specimens remain stable after centrifugation and show more accurate results than plasma. Therefore, a quick-clotting serum separator tube is expected to be useful for shorter turnaround times and accurate results. We evaluated a new quick-clotting serum separator tube VQ-Tube™ (AB Medical, Korea) for clinical chemistry and thyroid hormone assays.MethodsOne hundred volunteers from four university hospitals were recruited, and peripheral blood samples were collected in quick-clotting serum separator tube VQ-Tubes™ and the commonly used serum separator tube V-Tubes™. The obtained specimens were used for 16 clinical chemistry assays and three thyroid hormone assays.ResultsThe differences (%) in the test results obtained from the samples in each tube satisfied the allowable difference ranges (19 assays). The differences in the test results between the tubes satisfied the desired specifications for accuracy except for the glucose results (2.75%). The paired t-test revealed significant differences between the results of six assays, but each set of results showed a good correlation. Samples were visually inspected for serum clarity and gel barrier integrity, and incomplete clotting reactions and haemolysed serum were not observed.ConclusionsThe new quick-clotting VQ-Tube™ demonstrated reliable test results compared with the commonly used serum separator tube V-Tube™. This quick-clotting tube will provide fast test results with adequately separated serum specimens, especially for patients who need fast tests.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-26T05:32:59Z
      DOI: 10.1177/00045632211018245
       
  • Drug dosing using estimated glomerular filtration rate: Misclassification
           due to metamizole interference in a creatinine assay

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      Authors: Luana Bojko, Gustavo de Paula Ripka, Laura Mattana Dionísio, Celso Luiz Borges, Danielle Cristyane Kalva Borato, Mariane de Faria Moss
      First page: 474
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThe estimated glomerular filtration rate is a rather important measurement for patients under intensive care, since they often receive several drugs, and impaired renal function may result in misleading dosing. The estimated glomerular filtration is derived from mathematical models using serum creatinine, a measurement that suffers interference of some drugs, such as metamizole. This study intended to evaluate the impact on patient stratification for dose adjustment of two antimicrobials (meropenem and vancomycin) caused by metamizole interference in creatinine measurement by dry chemistry.MethodsA cross-sectional study was conducted with a group of 108 hospitalized patients under metamizole prescriptions at fixed intervals. Serum creatinine concentrations were determined by enzymatic dry chemistry and Jaffé assays, and the estimated glomerular filtration rate was calculated through the CKD-EPI equation. Patients were stratified in groups according to their estimated glomerular filtration rate for drug dosing of vancomycin and meropenem.ResultsCreatinine values were significantly lower in measurements performed by the dry chemistry method in comparison to Jaffé assay (P 
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-05-29T11:17:24Z
      DOI: 10.1177/00045632211020029
       
  • Routine use of natriuretic peptides: Lessons from a big data analysis

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      Authors: FX Goudot, S Msadek, T Boukertouta, PO Schischmanoff, C Meune
      First page: 481
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundNatriuretic peptides have broad indications during heart failure and the detection of left ventricular dysfunction in high-risk patients. They can also be used for the diagnosis/management of other cardiac diseases. However, very little is known regarding their use in routine practice.MethodsWe examined all biological tests performed from February 2010 to August 2015 in two districts from the French Brittany, covering 13,653 km2 and including 22,265 physicians. We report the settings and conditions of N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurements (the only locally natriuretic peptide available).ResultsFrom a total of 3,606,432 tests requested in 557,650 adult (older than 20 years) patients, only 56,653 (1.6%) included at least one NT-proBNP measurement. NT-proBNP measurements gradually increased, from 9188 in 2011 to 12,938 in 2014 (P 
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-03T05:55:27Z
      DOI: 10.1177/00045632211020779
       
  • Comparison of four high-throughput, automated immunoassays for the
           detection of SARS-CoV-2 antibodies

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      Authors: Jane Oakey, Shonagh Haslam, Andrew Brown, Janet Eglin, Brittany Houghton, Dawn Singleton
      First page: 487
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundA number of immunoassays have been developed to measure antibodies specific to SARS-CoV-2. More data is required on their comparability, particularly among those with milder infections and in the general practice population. The aim of this study was to compare four high-throughput automated anti-SARS-CoV-2 assays using samples collected from hospitalized patients and healthcare workers with confirmed SARS-CoV-2 infection. In addition, we collected general practice samples to compare antibody results and determine seroprevalence.MethodsSamples were collected from 57 hospitalized patients and nine healthcare workers at 14 days and at 28 days following confirmed SARS-CoV-2 infection. Samples were also collected from 225 patients presenting to general practice. Four assays were used: Abbott Architect IgG, Beckman Coulter DxI 800 IgG, Roche Cobas e801 total antibody and Siemens Advia Centaur XPT total antibody.ResultsAll four assays showed concordance at 14 days in 83.9% of hospitalized patients and in 66.7% of healthcare workers. All four assays showed concordance at 28 days in 88.4% of hospitalized patients and 77.8% of healthcare workers. The sensitivity to detect recent infection was higher for the IgG assays than the total assays. All four assays showed concordance of 95.1% in the general practice population. Seroprevalence ranged from 4.9 to 5.8% depending on the assay used.ConclusionsAll four assays showed excellent comparability, but it may be possible to obtain a negative result for any of the anti-SARS-CoV-2 assays in patients with confirmed previous SARS-CoV-2 infection. An equivocal range would be useful for all anti-SARS-CoV-2 assays.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-03T05:55:47Z
      DOI: 10.1177/00045632211015711
       
  • Performance characteristics of five SARS-CoV-2 serological assays:
           Clinical utility in health-care workers

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      Authors: Emma Heffernan, Lisa Kennedy, Margaret M Hannan, Navneet Ramlaul, Stephanie Denieffe, Garry Courtney, Alison Watt, John Hurley, Maureen Lynch, Maria Fitzgibbon
      First page: 496
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      Study objective:SARS-CoV-2, which causes coronavirus disease (COVID-19), continues to cause significant morbidity and mortality. The diagnosis of acute infection relies on reverse transcription-polymerase chain reaction (RT-PCR)-based viral detection. The objective of this study was to evaluate the optimal serological testing strategy for anti-SARS-CoV-2 antibodies which provides an important indicator of prior infection and potential short-term immunity.MethodsThe sensitivity and specificity of four different ELISA assays (Euroimmun IgG, Euroimmun NCP-IgG, Fortress and DIAsource) and one CLIA assay (Roche ELECSYS) were evaluated in 423 samples; 137 patients with confirmed RT-PCR COVID-19 infection (true positives), and 100 pre-pandemic samples collected prior to October 2019 (true negatives). A further 186 samples were collected from health-care staff and analysed by all five assays.ResultsThe Fortress ELISA assay demonstrated the highest sensitivity and specificity followed by the Roche ECLIA assay. The highest overall sensitivity came from the assays that measured total antibody (IgM–IgG combined) and the three assays that performed the best (Fortress, Roche, Euroimmun IgG) all have different antigens as their target proteins which suggests that antigen target does not affect assay performance. In mildly symptomatic participants with either a negative RT-PCR or no RT-PCR performed, 16.76% had detectable antibodies suggesting previous infection.ConclusionsWe recommend a combined testing strategy utilizing assays with different antigenic targets using the fully automated Roche ECLIA assay and confirming discordant samples with the Fortress Total Antibody ELISA assay. This study provides an important indicator of prior infection in symptomatic and asymptomatic individuals.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-03T05:56:08Z
      DOI: 10.1177/00045632211012728
       
  • Time-resolved fluorescence immunoassay for urine retinol-binding protein
           is more sensitive than polyclonal and monoclonal assays

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      Authors: Rashim Salota, Marta Lapsley, Ekramun Nabi, Simon Packer, Steve Hyer, Mark Dockrell
      First page: 505
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundRetinol-binding protein4 (RBP) assays using polyclonal antibodies (pRBP) have major problems of non-linearity of dilution and a very small useable dynamic range. Our objective was to develop a specific assay with a wider dynamic range to detect tubular proteinuria.MethodsmRBP (monoclonal capture and second antibody with colorimetric detection) and fluoroimmunoassays for RBP (fRBP) (polyclonal capture and monoclonal second antibody with fluorescence detection) were developed and compared with pRBP. Four hundred and eighty-eight patient samples were collected; 290 samples were analysed by mRBP and 198 samples with fRBP and compared with pRBP.ResultsmRBP assay has the advantages of better linearity on dilution and wider analytical range over pRBP. It is limited by poor signal in the patients with albuminuria and glomerular proteinuria and inferior discrimination between patient groups. fRBP had an intra-assay and inter-assay CV of
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-12T11:18:33Z
      DOI: 10.1177/00045632211020034
       
  • Elevated procalcitonin concentrations in severe Covid-19 may not reflect
           bacterial co-infection

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      Authors: Randeep S Heer, Amit KJ Mandal, Jason Kho, Piotr Szawarski, Peter Csabi, Dawn Grenshaw, Ian AL Walker, Constantinos G Missouris
      First page: 520
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundThe variability of Covid-19 severity between patients has driven efforts to identify prognosticating laboratory markers that could aid clinical decision-making. Procalcitonin is classically used as a diagnostic marker in bacterial infections, but its role in predicting Covid-19 disease severity is emerging. We aimed to identify the association between procalcitonin and Covid-19 disease severity in a critical care setting and whether bacterial co-infection is implicated.MethodsWe retrospectively reviewed Covid-19 patients with procalcitonin concentrations measured in a critical care setting at our institution between February and September 2020. Laboratory markers including peak procalcitonin values and a range of bacterial culture results were analysed. Outcomes were the requirement and duration of invasive mechanical ventilation as well as inpatient mortality.ResultsIn total, 60 patients were included; 68% required invasive mechanical ventilation and 45% died as inpatient. Univariate analysis identified higher peak procalcitonin concentrations significantly associated with both the requirement for invasive mechanical ventilation (OR: 3.2, 95% CI 1.3–9.0, P = 0.02) and inpatient mortality (OR: 2.6, 95% CI 1.1–6.6, P = 0.03). Higher peak procalcitonin concentrations was an independent predictor of mortality on multivariate analysis (OR 3.7, 95% CI 1.1–12.4, P = 0.03). There was a significant positive correlation between increased peak procalcitonin concentrations and duration on invasive mechanical ventilation. No significant difference was found between peak procalcitonin concentrations of patients with positive and negative bacterial cultures.ConclusionsElevated procalcitonin concentrations in Covid-19 patients are associated with respiratory failure requiring prolonged invasive mechanical ventilation and inpatient mortality. This association may be independent of bacterial co-infection.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-18T07:55:51Z
      DOI: 10.1177/00045632211022380
       
  • Assessing bone formation in patients with chronic kidney disease using
           procollagen type I N-terminal propeptide (PINP): The choice of assay makes
           a difference

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      Authors: Andreas Tridimas, Anna Milan, Eileen Marks
      First page: 528
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundMeasurement of procollagen type I N-terminal propeptide (PINP) concentration in serum reflects the rate of type I collagen synthesis and can therefore be used as a bone formation marker. There are two methods of PINP quantification; the first measures the trimeric propeptide (intact PINP) and the second measures both the trimeric and monomeric propeptides (total PINP). Trimeric PINP is excreted via hepatic endothelial cells, whereas monomeric PINP is cleared renally. Therefore, in renal failure, the total assay has a positive bias with respect to the intact assay, due to monomeric PINP accumulation. The aim of this study was to compare the performance of both assays across all stages of chronic kidney disease.MethodsSerum was taken from male (n = 111) and female (n = 105) patients attending a metabolic bone clinic, and these were partitioned into stages of chronic kidney disease 1–5. Each serum sample was analysed using the Roche electrochemiluminescence immunoassay for total PINP and the Immunodiagnostic Systems chemiluminescence immunoassay for intact PINP.ResultsPassing-Bablok regression analysis comparing both methods showed that with advancing chronic kidney disease there was a proportional positive bias affecting the total assay when compared with the intact assay. This proportional positive bias was statistically significant for chronic kidney disease stages 3b, 4 and 5.ConclusionsBased on this method comparison study, usage of the total PINP assay should be avoided in chronic kidney disease stages 3b, 4 and 5 (eGFR ≤44 mL/min/1.73 m2) and instead an intact assay used as the total assay overestimates PINP concentrations due to monomeric PINP accumulation.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-25T06:40:09Z
      DOI: 10.1177/00045632211025567
       
  • Method-dependent variation in TSH and FT4 reference intervals in
           pregnancy: A systematic review

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      Authors: Onyebuchi E Okosieme, Medha Agrawal, Danyal Usman, Carol Evans
      First page: 537
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.
      BackgroundGestational TSH and FT4 reference intervals may differ according to assay method, but the extent of variation is unclear and has not been systematically evaluated. We conducted a systematic review of published studies on TSH and FT4 reference intervals in pregnancy. Our aim was to quantify method-related differences in gestation reference intervals, across four commonly used assay methods, Abbott, Beckman, Roche and Siemens.MethodsWe searched the literature for relevant studies, published between January 2000 and December 2020, in healthy pregnant women without thyroid antibodies or disease. For each study, we extracted trimester-specific reference intervals (2.5–97.5 percentiles) for TSH and FT4 as well as the manufacturer-provided reference interval for the corresponding non-pregnant population.ResultsTSH reference intervals showed a wide range of study-to-study differences with upper limits ranging from 2.33 to 8.30 mU/L. FT4 lower limits ranged from 4.40 to 13.93 pmol/L, with consistently lower reference intervals observed with the Beckman method. Differences between non-pregnant and first trimester reference intervals were highly variable, and for most studies, the TSH upper limit in the first trimester could not be predicted or extrapolated from non-pregnant values.ConclusionsOur study confirms significant intra- and intermethod disparities in gestational thyroid hormone reference intervals. The relationship between pregnant and non-pregnant values is inconsistent and does not support the existing practice in many laboratories of extrapolating gestation references from non-pregnant values. Laboratories should invest in deriving method-specific gestation reference intervals for their population.
      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-06-26T06:24:18Z
      DOI: 10.1177/00045632211026955
       
  • Plasma clearance and lipaemic index of lipid emulsion used for lipid
           emulsion treatment

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      Authors: Ju-Tae Sohn
      First page: 547
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-02-02T04:24:12Z
      DOI: 10.1177/0004563221990686
       
  • Analytical method comparisons do not consider the comparison of reference
           ranges which may lead to differences in diagnosis and patient management:
           A case for clinical discordance checks

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      Authors: Tejas Kalaria, Anna Sanders, Jonathan Fenn, Clare Ford, Rousseau Gama
      First page: 549
      Abstract: Annals of Clinical Biochemistry, Ahead of Print.

      Citation: Annals of Clinical Biochemistry
      PubDate: 2021-04-21T04:32:04Z
      DOI: 10.1177/00045632211009920
       
 
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