Using a Rapid Communication Approach to Improve a POC Chlamydia Test

Abstract

Chlamydia trachomatis is a common sexually transmitted infection (STI) in young women. Available point-of-care (POC) diagnostic tests perform poorly, but development of new devices can be costly and time consuming. We explored the feasibility (user friendliness) and test characteristics (sensitivity, specificity) of a new prototype device to detect Chlamydia in adolescent women by using small numbers of subjects and rapid communication with the manufacturer. We compared cervical POC test results to the gold standard (cervical nucleic acid amplification testing). We also assessed the accuracy of the POC test on self-collected vaginal swabs by comparing results to cervical NAAT and to the cervical POC test. We frequently reviewed user experience and test results with the manufacturer. RESULTS Feasibility Initial device malfunctions were identified and corrected. The device would be easy to use in a non-clinical setting, as it is self-contained and the color change for some specimens was dramatic and immediate. Accuracy Initial prototypes demonstrated low sensitivities (38%) for vaginal and cervical swabs. After feedback, the company developed new prototypes with improved sensitivity (80%). However, the increased sensitivity was accompanied by a high percentage of indeterminate results and false positives that lowered specificity.

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

“…Structured interview items have been previously used in other of our studies to examine attitudes toward POC devices. 5,6 Questionnaire items were slightly modified from previously validated items evaluating sexually transmitted infection (STI) testing. 7,8…”

The performance of non-NAAT point-of-care (POC) tests and rapid NAAT tests for chlamydia and gonorrhoea infections. An assessment of currently available assays

“…Other chlamydia assays reviewed but not used in the modelling were ACON,11 Handilab-C,12 13 Clearview,9 10 Biovei,21 Chlamydia Test Card,20 Quickview13 and Biorapid13 which had sensitivities and specificities ranging from 12%–80% and 25%–100% respectively. Other gonorrhoea assays reviewed and not used in the modelling were Biostar (OIA)8 and NOW 23.…”

Diagnosis and Management of UncomplicatedChlamydia trachomatisInfections in Adolescents and Adults: Summary of Evidence Reviewed for the 2015 Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines

“…Since the previous literature review [7], 4 studies have been published on the performance of investigational CT POC tests [64][65][66][67]. Hesse et al evaluated the performance of 4 novel CT POC prototypes in succession, each modified based on communication with the manufacturer, on vaginal and cervical swabs compared with SDA [64].…”

“…Hesse et al evaluated the performance of 4 novel CT POC prototypes in succession, each modified based on communication with the manufacturer, on vaginal and cervical swabs compared with SDA [64]. The final CT POC prototype improved earlier problems but still had difficulties with readability of test results.…”