In Vitro Diagnostics Certification for Creatinine Assays in Korea over 7 Years: Achievements and Future Outlook
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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 manufactur- ing 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 analytical systems were evaluated. Average ac- ceptance rates for bias, imprecision, TE, and linearity were 70.8%, 95.9%, 87.7%, and 87.8%, respectively. The lowest acceptance rate for bias evaluation was 8.7% for the ki- netic Jaffe method without compensation in 2018. Over the 7-year period, the mean abso- lute percentage bias (absBias%), coefficient of variation (CV), and TE were 4.62%, 1.37%, and 7.29%, respectively. The highest absBias% (7.94%) was observed in the 0.0≤Cr<1.0 target value range. Since 2019, a consistent reduction in absBias% has been observed. Conclusions: This program is a pioneering response to the absence of a global certifica- tion program for Cr assays. It offers significant advantages, including comprehensive eval- uations, fee-free participation, and a robust post-certification process. Continuous partici- pation and improvement efforts by manufacturers have contributed to enhanced accuracy in Cr assays.
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 manufactur- ing 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 analytical systems were evaluated. Average ac- ceptance rates for bias, imprecision, TE, and linearity were 70.8%, 95.9%, 87.7%, and 87.8%, respectively. The lowest acceptance rate for bias evaluation was 8.7% for the ki- netic Jaffe method without compensation in 2018. Over the 7-year period, the mean abso- lute percentage bias (absBias%), coefficient of variation (CV), and TE were 4.62%, 1.37%, and 7.29%, respectively. The highest absBias% (7.94%) was observed in the 0.0≤Cr<1.0 target value range. Since 2019, a consistent reduction in absBias% has been observed. Conclusions: This program is a pioneering response to the absence of a global certifica- tion program for Cr assays. It offers significant advantages, including comprehensive eval- uations, fee-free participation, and a robust post-certification process. Continuous partici- pation and improvement efforts by manufacturers have contributed to enhanced accuracy in Cr assays.