C-149. Clinical Evaluation of the BD Viper™ System and the BD ProbeTec™ CTQx Amplified DNA Assay (CTQx) for the Direct Qualitative Screening of Chlamidia trachmonatis (CT) in Female Endocervical, Female Vaginal, and Female Urine Specimens

W. LeBar1, P. Fine2, D. Fuller3, E. Hook4, L. Mena5,6, B. VanDerPol7, S. Willis8, S. Taylor9;
1HCL-Providence Hosp., Southfield, MI, 2Planned Parenthood of Houston and Southeast Texas, Houston, TX, 3Wishard Hlth. Services, Indianapolis, IN, 4Univ. of Alabama, Birmingham, AL, 5Mississippi State Dept. of Hlth., Jackson, MS, 6Univ. of Mississippi Med. Ctr., Jackson, MS, 7Indiana Univ., Indianapolis, IN, 8San Joaquin Pub. Hlth., Stockton, CA, 9Louisiana State Univ. Hlth. Sci. Ctr., New Orleans, LA.

Background: The objective of the study was to examine the performance of female clinical specimens: endocervical swab, neat urine, Urine Preservative Transport (UPT) urine, and a self-collected vaginal swab on the BD Viper ™ System (in extracted mode) combined with the new CTQx assay vs. the patient infected status (PIS) for detection of CT. Methods: 511 female participants were enrolled from seven sites with both low and high chlamydial prevalence (1.5% - 19.2%). Both symptomatic and asymptomatic patients were included. Each participant was asked to provide a urine specimen, four endocervical swabs, and one self-collected vaginal swab. The first endocervical swab was either plated onto GC media for GC culture or was collected as the patient’s standard of care swab. The remaining three endocervical swabs were randomized. One endocervical swab and a urine specimen were tested using the BD ProbeTecTM ET System (PT), one endocervical swab and urine specimen was tested using the Gen-Probe APTIMA Combo2 (AC2) assay. The remaining endocervical swab, one vaginal swab, a UPT and a neat urine specimen were tested using the BD ViperTM System assay. For comparison, patient infected status was defined as positive when there was at least one positive test result from both FDA cleared assays (AC2 and PT) regardless of specimen type (endocervical or urine). Results: Following is the comparison of the CTQx Clinical Specimens vs. patient infected status Conclusions: The CTQx assay, using the BD ViperTM System, was highly sensitive and specific for the detection of CT in female clinical specimens when compared to patient infected status. Product not for sale, for investigational use only in the US.