Annals of Clinical Biochemistry

Is there utility in testing IgA-endomysial antibodies in patients with weak-positive or equivocal IgA-tissue transglutaminase antibodies in the diagnosis of coeliac disease? A critique of current NICE guidance (NG20)​Samuel D Brown, Jacqueline Hitchins, Newton ACS Wong, Amy Hayes, Alice Ogden, Adrian Heaps, Philip Bright1Clinical Biochemistry, Royal Sussex County Hospital, Brighton, UK2Clinical Biochemistry, 1984University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK3Department of Cellular Pathology, 1982North Bristol NHS Trust, Bristol, UK4Department of Immunology & Immunogenetics, 1982North Bristol NHS Trust, Bristol, UKon June 11, 2025 at 9:03 am

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Annals of Clinical Biochemistry, Ahead of Print. BackgroundCurrent coeliac disease (CD) NICE guidelines recommend testing IgA-endomysial antibodies (EMA) following a weak-positive IgA-tissue transglutaminase antibody (tTGA). Outside of patients with very high IgA-tTGA results, a positive IgA-EMA …

Detection of urinary SERPINA4 by electrochemiluminescence immunoassay and development of a diagnostic model for diabetic nephropathy​LiMei Yang, Huan Li, Fei Chen, Hui Zhang, Feng Wang, WenQian Guo, Ying Shen, ZiJie Liu1Yunnan Key Laboratory of Laboratory Medicine, Kunming, China2Department of Clinical Laboratory, 71240The First Affiliated Hospital of Kunming Medical University, Kunming, China3Department of Nephrology, 74621The First People’s Hospital of Yunnan Province, Kunming, China436657Department of Nephrology, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Chinaon June 11, 2025 at 9:13 am

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Annals of Clinical Biochemistry, Ahead of Print. Background and objectivesSERPINA4 has been identified as a potential diagnostic biomarker for diabetic nephropathy (DN) in our previous research. This study aims to develop electrochemiluminescence immunoassay (ECLIA) methods for the detection of SERPINA4 …

Relationships of serum levels of tocilizumab to interleukin-6 and endogenous markers of CYP3A activity in patients with rheumatoid arthritis​Takashi Mochizuki, Kaito Shibata, Takafumi Naito, Kumiko Shimoyama, Noriyoshi Ogawa, Junichi Kawakami1Department of Hospital Pharmacy, 12793Hamamatsu University School of Medicine, Hamamatsu, Japan2Department of Pharmacy, 118108Shinshu University Hospital, Nagano, Japan3Department of Internal Medicine Ⅲ, 12793Hamamatsu University School of Medicine, Hamamatsu, Japanon June 26, 2025 at 1:45 am

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Annals of Clinical Biochemistry, Ahead of Print. BackgroundTocilizumab co-administration and inflammatory conditions potentially alter the activity of cytochrome P450 (CYP) 3A4 by modulating the interleukin-6 (IL-6) signaling pathway in patients with rheumatoid arthritis (RA). This study aimed to …

A method comparison of the Roche intact PTH method versus the Roche whole PTH (1-84) method: Examining the differences based on eGFR​Byrne E, Twomey PJ, Crowley RK, McKenna MJ, Kilbane M1Department of Clinical Chemistry, 58038St. Vincent’s University Hospital, Dublin, Ireland2Department of Endocrinology, 58038St. Vincent’s University Hospital, Dublin, Irelandon June 24, 2025 at 4:55 am

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Annals of Clinical Biochemistry, Ahead of Print. AimThird-generation whole PTH (1-84) parathyroid hormone (PTH) assays do not recognize the PTH 7-84 fragment whereas second-generation (intact) assays detect both 1-84 and 7-84 PTH fragments. This study aimed to compare the second-generation Roche intact …

Establishment of a reference interval for calculated globulin on the Roche platform​Colleen Flannery, Alison Griffin, John Quinn, Clodagh Loughrey, Shari Srinivasan1Department of Chemical Pathology, 57978Beaumont Hospital, Dublin, Ireland2Department of Haematology, 57978Beaumont Hospital, Dublin, Ireland3School of Medicine, Royal College of Surgeons in Ireland, Dublin, Irelandon July 29, 2025 at 3:41 am

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Annals of Clinical Biochemistry, Ahead of Print. BackgroundCalculated globulin, based on direct measurement of total protein and albumin, can be a useful addition to the routinely requested liver profile. However, a reference interval, established using CLSI EP28-A3c recommended direct methods, is …

Analysis of first-trimester maternal serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels as a potential non-invasive biomarker for fetal aneuploidy and NTDs​Karthick E, Sathya Selvarajan, Dhivya Senthil Kumar, Sowmya K, Sridharan K S1Department of Biochemistry, 204733Sri Ramachandra Institute of Higher Education and Research, Chennai, India2Clinical Biochemistry and Quality Manager, 653410MGM Healthcare, Chennai, India3Department of Laboratory Medicine, 204733Sri Ramachandra Institute of Higher Education and Research, Chennai, Indiaon July 29, 2025 at 3:40 am

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Annals of Clinical Biochemistry, Ahead of Print. ObjectivesChromosomal abnormalities and congenital anomalies have huge impact on infant mortality and morbidity. The combined incidence affects approximately 1 per 1000 pregnancies. Current diagnostic modalities include ultrasonography and biomarkers like …

The missing piece: Who is responsible for ensuring clinical chemistry assays used in the UK are fit for purpose?​Rachel Marrington, Gordon Sinclair, Finlay MacKenzie1Birmingham Quality (UK NEQAS), University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK24904School of Human Sciences, London Metropolitan University, London, UKon July 29, 2025 at 3:33 am

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Annals of Clinical Biochemistry, Ahead of Print. Over the past 50 years, External Quality Assessment (EQA) Schemes in the UK have changed from being overseen by the Department of Health and Social Security (DHSS) to a self-funding model post-1990, increasing competition among schemes. Despite reforms, …

Validation of the Japan Society of Clinical Chemistry (JSCC) recommended reference measurement procedure for glycated albumin determination​Shu Meguro, Yusuke Iwasaki, Junpei Ueda, Mikiko Okahashi, Yukio Kume, Takuji Kohzuma, Eri Shimizu, Hiroko Takeda, Satoshi Hirayama, Emiko Hosoba, Terumichi Nakagawa, Asako Sato1Division of Nephrology, Endocrinology, and Metabolism, Department of Internal Medicine, Keio University School of Medicine, Internal Medicine, Tokyo, Japan2Department of Analytical Chemistry, Hoshi University School of Pharmacy and Pharmaceutical Sciences, Tokyo, Japan3Clinical Laboratory, 34787Keio University Hospital, Tokyo, Japan4Japan Reference Measurement Institute, Kawasaki, Japan5Department of Clinical Laboratory, 13143The University of Tokyo Hospital, Tokyo, Japan6IVD Kit Product Dept. Diagnostics Division, Nagase Diagnostics, Tokyo, Japan7Reference Material Institute for Clinical Chemistry Standards, Yokohama, Japan8Clinical Laboratory Department, 38562Tokyo Saiseikai Central Hospital, Tokyo, Japan9Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan10Health Service Center, 13135Tokyo Gakugei University, Tokyo, Japan11Department of Transplant Immunology, 36595Tokyo Women’s Medical University Hospital, Tokyo, Japan12Department of Clinical Laboratory, Tokyo Women’s Medical University, Tokyo, Japanon July 29, 2025 at 3:38 am

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Annals of Clinical Biochemistry, Ahead of Print. BackgroundTo clarify the fundamental characteristics of the Japan Society of Clinical Chemistry reference measurement procedure (JSCC RMP) for glycated albumin (GA), an additional performance study was performed and the correlation between the HPLC method …

Elevated CA19-9 in IgG4-related disease​Derrick HY Chong, Andre Mattman, Aaron Dou, Anthony So, Howard J Lim, Junyan Shi, Richard Cleve, David F Schaeffer, Eric CS Lam, Jennifer J Telford, Luke YC Chen, Mollie N Carruthers1Temerty Faculty of Medicine, 7938University of Toronto, Toronto, ON, Canada2Department of Pathology and Laboratory Medicine, 8156St. Paul’s Hospital, Vancouver, BC, Canada3Artus Health Centre, Vancouver, BC, Canada4Division of Medical Oncology, 8144BC Cancer, Vancouver, BC, Canada5Department of Pathology and Laboratory Medicine, 8167Vancouver General Hospital, Vancouver, BC, Canada6Department of Laboratory Medicine and Pathology, Fraser Health Authority, Surrey, BC, Canada7Division of Gastroenterology, 8166University of British Columbia, Vancouver, BC, Canada8Division of Hematology, 8166University of British Columbia, Vancouver, BC, Canada9Division of Hematology, Dalhousie University, Halifax, NS, Canada10258853Arthritis Research Canada, Vancouver, BC, Canadaon August 8, 2025 at 6:34 am

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Annals of Clinical Biochemistry, Ahead of Print. BackgroundIgG4-related disease (IgG4-RD) is an inflammatory disease that can clinically mimic pancreatic and hepatobiliary cancer. Serum carbohydrate antigen 19-9 (CA19-9) is a tumour marker that is frequently used to aid in the diagnosis of biliary …

The early diagnostic value of C-reactive protein (CRP) in deep sternal wound infection after cardiac surgery​Shanshan Jia, Jie Zhao, Jixun Zhang, Duyin Jiang1The Second Clinical College of Shandong University, Jinan, China2Department of Plastic and Burns Surgery, 531675The Second Hospital of Shandong University, Jinan, China3Department of Emergency Medicine Center, 531675The Second Hospital of Shandong University, Jinan, Chinaon June 11, 2025 at 9:32 am

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Annals of Clinical Biochemistry, Ahead of Print. BackgroundThis study aimed to evaluate the early diagnostic value of C-reactive protein (CRP), procalcitonin (PCT), white blood cell count (WBC), neutrophil ratio (NEUT%), and neutrophil-to-lymphocyte ratio (NLR) in patients with deep sternal wound …

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