Setting clinical performance specifications to develop and evaluate biomarkers for clinical use

Annals of Clinical Biochemistry International Journal of Laboratory Medicine

DOI: 10.1177/0004563219842265 Full text (OA) OpenAlex

Authors 0

Author list not loaded yet.

Cited by 7 stored of 35

Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics
2025 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access

12

citations
Is this test fit-for-purpose? Principles and a checklist for evaluating the clinical performance of a test in the new era of in vitro diagnostic (IVD) regulation
2025 Critical Reviews in Clinical Laboratory Sciences review Medicine Clinical Laboratory Practices and Quality Control Open access

13

citations
Developing an SI-traceable Lp(a) reference measurement system: a pilgrimage to selective and accurate apo(a) quantification
2023 Critical Reviews in Clinical Laboratory Sciences review Medicine Lipoproteins and Cardiovascular Health Open access

44

citations
Serum N-glycan profiles differ for various breast cancer subtypes
2021 Glycoconjugate Journal article Biochemistry, Genetics and Molecular Biology Glycosylation and Glycoproteins Research Open access

28

citations
Rational selection of a biomarker panel targeting unmet clinical needs in kidney injury
2021 Clinical Proteomics article Medicine Acute Kidney Injury Research Open access

23

citations
We need to talk about the analytical performance of our laboratory developed clinical LC-MS/MS tests, and start separating the wheat from the chaff
2020 Clinica Chimica Acta article Medicine Clinical Laboratory Practices and Quality Control Open access

11

citations
Mass spectrometry in clinical glycomics: The path from biomarker identification to clinical implementation
2020 Clinical mass spectrometry article Biochemistry, Genetics and Molecular Biology Glycosylation and Glycoproteins Research Open access

32

citations

7 results

Setting clinical performance specifications to develop and evaluate biomarkers for clinical use

Authors 0

Cited by 7 stored of 35

References 0