(P105) (Withdrawn) BD ELIENCE POC CT/GC MOLECULAR ASSAYS FOR THE RAPID DETECTION OF CHLAMYDIA AND GONORRHEA INFECTIONS IN MALE AND FEMALE PATIENTS AT THE POINT-OF-CARE IN LESS THAN 20 MINUTES

Background:
In 2022, the CDC reported >2.3 million chlamydia and gonorrhea cases nationally. The BD Elience POC CT/GC – Urine and Vaginal Assays and instrument* are fully automated rapid molecular in vitro diagnostic tests utilizing Archaeal Polymerase Amplification for the qualitative detection of nucleic acids from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in point-of-care and clinical laboratory settings in under 20 minutes from male urine and vaginal swab specimens.

Methods:
In a prospective clinical simulation study, first catch male urine specimens were collected between November 2022 and March 2023 from symptomatic and asymptomatic participants at four collection sites and stored frozen. Aliquots were prepared to test with the BD Elience POC CT/GC Urine assays* and reference assays. The composite molecular comparator was calculated using the results from Cepheid Gene Xpert CT/NG, BD ProbeTec Qx CT and GC assays on Viper LT, and BD MAX CTGCTV2 (two out of three algorithm).

In a benchmarking study against other CT/GC assays, a contrived model was used leveraging frozen vaginal swabs from asymptomatic donors spiked with quantified CT and GC target stocks at four clinically relevant titers.

Results:
For BD Elience POC CT/GC Urine assays*, a PPA of 93.94% (CI 79.8-99.3%) and a NPA of 99.4% (CI 96.7-99.8%) were reported for CT, and a PPA of 96.6% (CI 82.2-99.99%) and NPA of 100% (CI 98.26-100%) were reported for GC.

For CT and GC detection, BD Elience POC Vaginal assay* achieved comparable performance to on-market POC platforms, Binx i/o CT/NG assay, and Visby Medical Sexual Health, with BD MAX CTGCTV2 assay as reference.

Conclusion:
The BD Elience POC CT/GC-Urine and Vaginal Assays and instrument* aim to provide clinically relevant results for CT and GC infections in male and female populations in less than 20 minutes.

*Note: The BD Elience POC platform is in development and not FDA-cleared