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Using a Rapid Communication Approach to Improve a POC Chlamydia Test

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4 Author(s)
Hesse, E.A. ; Cincinnati Children''s Hosp. Med. Center, Cincinnati, OH, USA ; Patton, S.A. ; Huppert, J.S. ; Gaydos, C.A.

Chlamydia trachomatis is a common sexually transmitted infection 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 and 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 nucleic acid amplification test and to the cervical POC test. We frequently reviewed user experience and test results with the manufacturer. The results showed the feasibility and accuracy of the device. Feasibility - initial device malfunctions were identified and corrected. This device would be easy to use in a nonclinical 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.

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Biomedical Engineering, IEEE Transactions on  (Volume:58 ,  Issue: 3 )