Journal

Short- and medium-term pre-analytical stability of human serum insulin-like growth factor-1Jaco C Louwon October 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 31. doi: 10.1515/cclm-2025-0868. Online ahead of print. ABSTRACT OBJECTIVES: Insulin-like growth factor-1 (IGF-1) is a peptide hormone currently lacking data surrounding its pre-analytical stability. This study aimed to investigate the impact of delaying centrifugation and analysis at different storage temperatures on the in vitro stability of IGF-1. METHODS: The … Read more

A robust ddPCR assay for the absolute quantification of miR-192-5p in hepatocellular carcinoma liquid biopsiesXinmiao Liuon October 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 31. doi: 10.1515/cclm-2025-0824. Online ahead of print. ABSTRACT OBJECTIVES: MicroRNA-192-5p, a liver-enriched miRNA downregulated in hepatocellular carcinoma (HCC), is a promising biomarker, but its clinical use is limited by technical challenges in detecting low-abundance plasma miRNAs. This study innovatively uses droplet digital PCR (ddPCR) with locked nucleic acid (LNA)-modified … Read more

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 …

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