Performance of the Atlas Genetics Rapid Test for Chlamydia trachomatis and Women's Attitudes Toward Point-Of-Care Testing.

PURPOSE

This study compared performance of the Atlas io polymerase chain reaction-based, point-of-care (POC) assay for Chlamydia trachomatis (CT), to Aptima Combo 2, a standard of care nucleic acid amplification assay, and evaluated patient attitudes toward POC testing.

METHODS

Women 14 years or older undergoing CT screening/testing were recruited from Teen Health Center and a sexually transmitted disease clinic. Participants provided self-obtained vaginal swabs for testing with the Atlas io and Aptima Combo 2, and completed questionnaires assessing attitudes toward POC testing.

RESULTS

Of 296 women recruited, 284 (192 from sexually transmitted disease clinic, 92 from Teen Health Center) had Aptima Combo 2 and Atlas io results available; 273 completed the questionnaire. Average age was 27.4 years (SD, 10.8 years). Sensitivity and specificity of the Atlas io test were 83.9% (26/31 specimens; 95% confidence interval [CI], 70.9-96.8%) and 98.8% (250/253 specimens; 95% CI, 97.5-100%), respectively. When specimens with discrepant results were included in the analyses, adjudicated sensitivity and specificity were 92.9% (26/28 specimens; 95% CI, 83.3 to 100%) and 98.8% (253/256 specimens; 95% CI, 97.5 to 100%), respectively.A majority (70%) of women preferred to collect vaginal self-swab if a POC test were available. Most (61%) were willing to wait up to 20 minutes, and 26% were willing to wait up to 40 minutes for results, if they could be treated before leaving clinic.

CONCLUSIONS

A POC polymerase chain reaction test detecting CT had high sensitivity and specificity when testing prospective, vaginal swab samples. Availability of CT results during patients' visits may decrease time to treatment.