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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 …

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

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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

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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

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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

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