Quantification of Difference in Nonselectivity Between In Vitro Diagnostic Medical Devices.

ABSTRACT: Correct measurement results from in vitro diagnostic (IVD) medical devices (MD) are crucial for optimal patient care. The performance of IVD-MDs is often assessed through method comparison studies. Such studies can be compromised by the influence of various factors. The effect of these factors must be examined in every method comparison study, for example, nonselectivity differences between compared IVD-MDs are examined. Historically, selectivity or nonselectivity has been defined as a qualitative term. However, a quantification of nonselectivity differences between IVD-MDs is needed. This paper fills this need by introducing a novel measure for quantifying differences in nonselectivity (DINS) between a pair of IVD-MDs. Assuming one of the IVD-MDs involved in the comparison exhibits high s

SUBMITTER: Fauskanger PK 

PROVIDER: S-EPMC11695778 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature