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

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

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 …

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

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

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

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 …

Hierarchy of reference interval models: advancing laboratory data interpretationThomas Streicherton October 28, 2025 at 10:00 am

Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-1234. Online ahead of print. ABSTRACT Accurate interpretation of laboratory data is a critical step in clinical decision-making. This requires the availability of reliable reference data for comparison. Reference data can be derived from various sources, including hospital or laboratory databases, groups of reference individuals, or an … Read more

Small-scale external quality assessment of methylated SHOX2 and RASSF1A detection in China: findings from 2023-2024Chengxiang Chuon October 28, 2025 at 10:00 am

Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-0846. Online ahead of print. ABSTRACT OBJECTIVES: DNA methylation in short homeobox gene 2 (SHOX2) and RAS association domain family protein 1 (RASSF1A) shows significant auxiliary diagnostic value for early-stage lung cancer. However, the detection accuracy is frequently compromised because of the complexity of the analytical procedures. … Read more

Development and validation of a machine learning model for accurate detection of wrong blood in tube errors in hospitalized patientsJordi Tortosa-Carrereson October 28, 2025 at 10:00 am

Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-0564. Online ahead of print. ABSTRACT OBJECTIVES: To develop and validate a machine-learning model based on routinely available biochemical and hematological parameters for detecting wrong blood in tube (WBIT) errors in hospitalized patients. METHODS: A retrospective multicenter study including one internal cohort (IC) and two external validation … Read more

Saliva sampling matters for salivary diagnostics of viral infectionsChuixi Kongon October 28, 2025 at 10:00 am

Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-0607. Online ahead of print. ABSTRACT Saliva, a non-invasive biofluid with a variety of biomolecules, has been increasingly recognized as a reliable specimen in the diagnostics of viral infections. Compared to the standard specimens represented by blood and nasopharyngeal swab, saliva is advantageous in non-invasive, simple collection, … Read more

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