Extent of Equivalence of Results for Urine Albumin among 3 Candidate Mass Spectrometry Reference Measurement Procedures.
Clin Chem
; 2024 Aug 29.
Article
en En
| MEDLINE
| ID: mdl-39206663
ABSTRACT
BACKGROUND:
Urine albumin (UA) is an important biomarker of chronic kidney disease. Current in vitro diagnostic medical devices (IVD-MDs) for measuring UA are not standardized, and median results among IVD-MDs differ by approximately 45%. Since fixed decision values are used to interpret UA, higher-order reference measurement procedures (RMPs) are needed for metrological traceability. Three candidate liquid chromatography-tandem mass spectrometry RMPs have been developed for UA.METHODS:
Eight single-donation human urine samples were measured by 3 candidate RMPs. Results were compared using t-test and variance component analysis.RESULTS:
The mean results for each urine sample from each RMP laboratory were not statistically different from the overall mean value by t-test. The median total CV including contributions from bias and imprecision among the 3 RMP laboratories was 6.23% using variance component analysis for each sample. The allowable bias to the RMP for an end-user IVD-MD was â¦9.0% or â¦3.0% based on the desirable or optimal total allowable error of 30% or 24%, respectively. A maximum allowable standard uncertainty for an RMP result was determined to be 4.3% or 3.3% for desirable or optimal performance, respectively. The standard uncertainties for all of the RMP laboratories meet the desirable and optimal standard uncertainty specifications.CONCLUSION:
The candidate RMPs for UA in these 3 laboratories have suitable agreement of results and uncertainties for use as higher-order RMPs in the metrological traceability of end-user IVD-MDs for measuring UA.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Idioma:
En
Revista:
Clin Chem
Asunto de la revista:
QUIMICA CLINICA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Estados Unidos