(P467) Performance of the BD Vaginal Panel for BD COR™ System as compared to the BD Vaginal Panel for BD MAX™ System

Background

Vaginitis is a common complaint, traditionally diagnosed either empirically or using Amsel’s criteria and wet mount microscopy. However, molecular-based assays have shown good clinical performance for vaginitis detection. Here we determine the performance of the BD Vaginal Panel (VP) on the high-throughput BD COR™ (MX/GX) System (COR) when compared to VP on the BD MAX™ system (MAX).



Materials and Methods

To determine the agreement of VP results on the COR versus MAX systems, specimen-level compliant and platform-level reportable samples (either contrived or clinical) were prepared to yield test groups. Testing order on COR versus MAX alternated for the panels. Acceptance criteria for COR agreement to MAX was as follows: for BV, a point estimate for positive percent agreement (PPA) of ≥95% and a point estimate for negative percent agreement (NPA) of ≥98% was required; for Cgroup, C. glabrata, C. krusei, and TV, a PPA and NPA point estimate of ≥95% (with lower bound of 95% confidence interval [95% CI] ≥90%) was required. Replicates from individual samples were testing on three COR and three MAX platforms. Testing occurred across three sites and the study was reviewed and approved by relevant ethics committees prior to study-related activities.



Results

PPA was 99.5% [95% CI: 97.5-100] (n=516) and 97.9% [95% CI: 96.5-98.8] for contrived BV (n=516) and clinical BV (n=1,050) specimens, respectively. For Cgroup (clinical; n=724), C. glabrata (contrived; n=544), C. krusei (contrived; n=522), and TV (clinical; n=702), PPA was 99.4% [95%CI: 98.0-99.9], 100% [95%CI: 97.9-100 ], 100% [95%CI: 97.6-100], and 99.7 [95%CI: 98.3-100], respectively. NPA was >95% for BV contrived and for BV clinical specimens. For Cgroup, C. glabrata, C. krusei, and TV, NPA was ≥98.9%; the highest lower bound CI value was 97.3.



Conclusions

COR met acceptance criteria for all evaluated vaginitis targets and demonstrated equivalent performance to MAX. These results demonstrate equivalent performance of the VP assay on COR versus MAX systems.