<i>In Vitro</i> Diagnostics Certification for Creatinine Assays in Korea over 7 Years: Achievements and Future Outlook.

ABSTRACT:

Background

: An international reference measurement laboratory network for creatinine (Cr) is lacking; therefore, Korea developed an independent evaluation and certification system. The in vitro diagnostics (IVD) certification program, launched in 2017, formed part of a broader Cr standardization initiative intended to enhance accuracy at the manufacturing stage.

Methods

: The program was designed to evaluate analytical systems, including all reagent lots, calibrators, and instrument models, twice annually. Bias, imprecision, total error (TE), and linearity were evaluated based on established acceptance criteria. A post-certification process allows submission for a second challenge and validation of corrective actions.

Results

: Between 2017 and 2023, 489 analy

SUBMITTER: Cho EJ 

PROVIDER: S-EPMC12370804 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature