Performance characteristics of the light-initiated chemiluminescent assay for quantitative determination of progesterone.

ABSTRACT

BACKGROUND: To study the performance of quantitative determination of progesterone by light-initiated chemiluminescent assay (LICA). METHODS: Clinical samples of serum were used for detection of progesterone by LICA. The precision study was performed according to Clinical and Laboratory Standards Institute (CLSI) EP15-A3, the linear range validation was performed according to CLSI EP06-A, accuracy was evaluated according to CLSI EP9-A3, and the performance of detection capability was confirmed according to CLSI EP17-A2. All data were analyzed using SPSS software. Function regression analysis was performed by OriginPro software. RESULTS: The LICA-800 system exhibited low coefficients of variation (CVs) and high reproducibility, and the calculated synthetic CV was 2.16%. The access progesterone assay showed excellent linearity in the assay measuring range (0.37-40 ng/mL) using the polynomial regression method in accordance with CLSI EP06-A. Bias assessment was used to verify accuracy, and the percentage deviation met the quality requirements of the laboratory's allowable deviation of 10.00%. In terms of the detection capability of LICA, the calculated limit of blank (LoB) was 0.046 ng/mL, limit of detection (LoD) was 0.057 ng/mL, and the limit of quantitation (LoQ) value was 0.161 ng/mL. CONCLUSIONS: The competitive LICA provided a highly sensitive, accurate and precise method for measuring serum progesterone level.