Analytical Validation of the IMMULITE® 2000 XPi Progesterone Assay for Quantitative Analysis in Ovine Serum

Monitoring circulating progesterone (P4) concentration is an important component of basic and applied reproduction research and clinical settings. IMMULITE (R) 2000 XPi (Siemens) is a newly upgraded fully automated immunoassay system marketed for human use to measure concentrations of different analytes including P4. Our objective was therefore to characterize the analytical performance of the IMMULITE (R) 2000 XPi P4 immunoassay across the reportable range in ovine serum. This validation of analytical performance included determining (1) linearity, (2) precision through within-run, and between-run coefficient of variation (CV) calculations, (3) accuracy through bias calculations for spiking-recovery bias and interlaboratory (range and average based) bias for two laboratories across the reportable range (0.2-40 ng/mL). The average within-run and between-run precision (CV%) across the reportable range of the IMMULITE (R) 2000 XPi P4 immunoassay for serum P4 concentration were both <5%, ranging between 2-8%. The average Observed Total Analytic Error (TEo) reported here for serum P4 concentration across the reportable range was similar to 30%, ranging from 14.8-59.4%, regardless of the considered bias. Based on these data we conclude that the automated IMMULITE (R) 2000 XPi P4 immunoassay provides a precise, accurate, reliable, and safe method for measuring P4 concentration in ovine serum.

Automated summary

This study aimed to evaluate the analytical performance of the newly upgraded fully automated immunoassay system IMMULITE (R) 2000 XPi P4 immunoassay and validate its accuracy and precision in measuring P4 concentration in ovine serum. The results showed that the system exhibited good precision and accuracy within the reportable range.