Clin Chem. 2025 Oct 14:hvaf123. doi: 10.1093/clinchem/hvaf123. Online ahead of print. ABSTRACT The European Union (EU) In Vitro Diagnostic Regulation (IVDR) imposes stringent obligations on laboratories using in-house in vitro diagnostic devices (IH-IVDs), yet offers limited clarity on whether discrete work flow steps may be subcontracted while maintaining compliance with Article 5(5). This Special Report … Read more

Clin Chem. 2025 Oct 13:hvaf120. doi: 10.1093/clinchem/hvaf120. Online ahead of print. ABSTRACT BACKGROUND: Serum glial fibrillary acidic protein (GFAP) is a biomarker for astrocytic injury and astrogliosis. Concentrations are elevated in numerous neurological disorders, including a pronounced increase in Alzheimer disease (AD). However, GFAP levels in the serum also increase with age. Consequently, the integration … Read more

Clin Chem. 2025 Oct 13:hvaf114. doi: 10.1093/clinchem/hvaf114. Online ahead of print. ABSTRACT BACKGROUND: The past 2 decades have seen rapid advances in the development of the concept of personalized nutrition (PN) interventions, and in its application. PN has evolved from attempts to understand the well-recognized interindividual variability in response to dietary intervention that have been … Read more

Clin Chem. 2025 Oct 10:hvaf122. doi: 10.1093/clinchem/hvaf122. Online ahead of print. ABSTRACT BACKGROUND: External quality assessment (EQA) should strive to monitor and reflect variation across laboratories and measuring systems. We introduce a newly developed patient-based EQA program named Noklus Patient Median (NOPAM) that is freely available for the participants. The results from NOPAM enable laboratories … Read more

Clin Chem. 2025 Oct 10:hvaf110. doi: 10.1093/clinchem/hvaf110. Online ahead of print. ABSTRACT BACKGROUND: Estimated glomerular filtration rate (eGFR) using creatinine (eGFRcr), cystatin C (eGFRcys), or both (eGFRcr-cys) is not sufficiently accurate in many settings, often due to non-glomerular filtration rate (GFR) determinants of the filtration markers. In principle, using a panel of endogenous markers (panel … Read more

Clin Chem. 2025 Oct 3;71(10):1018-1022. doi: 10.1093/clinchem/hvaf062. NO ABSTRACT PMID:41038613 | DOI:10.1093/clinchem/hvaf062

Clin Chem. 2025 Oct 3;71(10):1095-1096. doi: 10.1093/clinchem/hvaf105. NO ABSTRACT PMID:41038612 | DOI:10.1093/clinchem/hvaf105

Clin Chem. 2025 Oct 3;71(10):1097-1098. doi: 10.1093/clinchem/hvaf089. NO ABSTRACT PMID:41038611 | DOI:10.1093/clinchem/hvaf089

Clin Chem. 2025 Oct 3;71(10):1022. doi: 10.1093/clinchem/hvaf104. NO ABSTRACT PMID:41038610 | DOI:10.1093/clinchem/hvaf104

Clin Chem. 2025 Oct 3;71(10):1023. doi: 10.1093/clinchem/hvaf091. NO ABSTRACT PMID:41038609 | DOI:10.1093/clinchem/hvaf091