Validation of a New High-Throughput BD COR System Using the BD CTGCTV2 Assay

Abstract

This study determined the precision and reproducibility of results for the BD CTGCTV2 (CTGCTV2) assay on the BD COR System (COR). The clinical performance of the CTGCTV2 assay conducted on COR was compared with its performance on the BD MAX System (MAX) for detecting Chlamydia trachomatis, Neisseria gonorrhoeae, or Trichomonas vaginalis. The multiday precision and multisite reproducibility studies were conducted using contrived panels of positive and negative urine and PreservCyt specimens. A total of 433 panel members, generated from remnant clinical specimens, were tested in the clinical comparison study. Each panel member was tested three times on MAX and three times on COR. The results in the same testing group were compared for agreement by target. The cycle threshold scores from MAX and COR were analyzed by paired t-test and Deming regression. The CTGCTV2 assay on COR showed high reproducibility in the multiday and multisite precision analysis. The point estimates of positive percent agreement and negative percent agreement in the clinical comparison study for all three targets were greater than 95%, with all corresponding lower bounds of two-sided 95% CIs greater than 90%. Cycle threshold score comparison showed no systematic difference between the two systems. The results of this study show equivalent performance of the CTGCTV2 assay on the MAX and COR systems.