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Background: Screening with nucleic acid amplification tests (NAATs) is recommended to decrease the Chlamydia trachomatis epidemic in young women, however NAATs are costly and time consuming.
Objectives: To assess the performance of two point-of-care (POC) prototype test devices (A or B) to detect Chlamydia on vaginal and cervical samples.
Methods: Women (age 15-30 years) presenting for a pelvic exam were recruited. For each subject, a self-collected vaginal swab and a clinician-obtained cervical swab were tested with the same POC device. Chlamydia infection was defined as a positive cervical NAAT (strand displacement assay). Sensitivity, specificity, 95% confidence intervals (CI), and agreement between vaginal and cervical swabs were calculated.
Results: Of the first 128 subjects, 30 completed testing with device A and 98 with device B. Of these, 22 (17%) were Chlamydia NAAT positive. Device A was 38% sensitive (CI: 8-76%) compared to NAAT for both cervical and vaginal samples, while specificity was 77% (CI: 54-92%) for cervical and 64% (CI: 40-83%) for vaginal swabs. Compared to NAAT, Device B for cervical swabs was 43% sensitive (CI: 18-71%) and 99% specific (CI: 93-90%). For vaginal swabs, device B was 7% sensitive (CI: 0.2-34%) and 95% specific (CI: 88-99%). Agreement between vaginal and cervical swab results was moderate for device A (kappa 0.62), but only fair for device B (kappa 0.29).
Conclusions: Preliminary results showed disappointing sensitivities for both POC devices for cervical and vaginal samples. Specificity of device A was poor, but was very good for device B. A larger sample size would provide more reliable estimates of test performance in high and low risk women.
Implications for Programs, Policy, and/or Research: Sensitive POC tests are needed for CT screening, and highly specific POC tests could hasten diagnosis in infected women. Accurate vaginal swab POC tests would be important for non-clinical settings.