A rapid, single-use, point-of-care polymerase chain reaction (PCR) device, the Visby Medical Sexual Health Test (Visby Medical), which is used to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections in women, showed excellent agreement with other US Food and Drug Administration (FDA)-approved laboratory-based assays, according to study results published in the Lancet Infectious Diseases.
To measure the performance of the Visby Medical Sexual Health Test, researchers conducted a cross-sectional, single-visit study (ClinicalTrials.gov identifier: NCT03852316) of females ages 14 years and older at 10 clinics across 7 US states. Women provided self-collected vaginal swabs for testing with the Visby Medical Sexual Health Test, and an untrained operator used the specimen to run the device using the quick-start instructions. According to the protocol, the test needs to be run within 2 hours of collection, and the results are delivered in under 30 minutes.
To assess patient-infected status, the sensitivity and specificity of the Visby Medical Sexual Health Test was compared with 3 approved comparator assays using vaginal specimens collected by licensed healthcare providers: 1) Aptima Combo 2® Assay and Aptima® Trichomonas vaginalis Assay (Hologic); 2) BD ProbeTec™ CT/GC Qx Amplified DNA Assay and BD ProbeTec™ Trichomonas vaginalis Qx Assay (BD Molecular Diagnostics); and, 3) BD MAX™ CT/GC/TV (BD Molecular Diagnostics).
Of the 1585 women (mean age, 34.8 years) enrolled in the study, 1555 of participants had the test run using the Visby Medical Sexual Health Test with 92.9% and 5.7% having a valid result on the first and second try, respectively. When compared with patient-infected status, the sensitivity and specificity for the Visby Medical Sexual Health Test for each organism was as follows:
- C trachomatis, n=1457: sensitivity of 97.6% (95% CI, 93.2%-99.2%) and specificity of 98.3% (95% CI, 97.5%-98.9%)
- N gonorrhoeae, n=1468: sensitivity of 97.4% (95% CI, 86.5%-99.5%) and specificity of 99.4% (95% CI, 98.9%-99.7%)
- T vaginalis, n=1449: sensitivity of 99.2% (95% CI, 95.5%-99.9%) and specificity of 96.9% (95% CI, 95.8%-97.7%)
Results remained similar when the analysis was stratified by symptomatic and asymptomatic status. The Visby Medical Sexual Health Test also delivered an overall accuracy (agreement with patient-infected status) in 98.3% (95% CI, 97.5%-98.8%) of results for C trachomatis, 99.4% (95% CI, 98.8%-99.7%) for N gonorrhoeae, and 97.1% (95% CI, 96.1%-97.8%) for T vaginalis.
Limitations of this study included the moderate number of N gonorrhoeae cases. In addition, the Visby Medical Sexual Health Test will need to be validated with samples from all genders and anatomic sites, the researchers noted.
“Results from this study were used to support a regulatory submission and Clinical Laboratory Improvement Act (CLIA) waiver submission to the FDA for the first rapid, simple, molecular, point-of-care testing device for [sexually transmitted infections],” the researchers concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Morris SR, Bristow CC, Wierzbicki MR, et al. Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional study. Lancet Infect Dis. 2020;S1473-3099(20)30734-30739. doi:10.1016/S1473-3099(20)30734-9