Objectives To quantify detection of syphilis with the DETERMINE^® Syphilis test versus single or combined treponemal/cardiolipin tests in a Primary Care setting.

Methods The 107 positive DETERMINE^® syphilis results obtained in 1898 samples were compared to combined RPR/VDRL and FTA results. True positives were defined as either serological confirmation by either cardiolipin and/or specific treponemal positive results at diagnosis or at 1 week follow-up, or signs and symptoms classically compatible with syphilis which resolved completely and rapidly on administration of single dose benzathine penicillin G. All positive cases showed a sustained positive result in the DETERMINE^® Syphilis test at follow-up. False positive tests with DETERMINE^® Syphilis test were defined as being non-confirmed by combined cardiolipin and specific treponemal positive tests at baseline and negativity in the follow-up period.

Results Of all positive results with the DETERMINE^® Syphilis test 14.0% were shown to be true positive results by fulfilling one or more of the aforementioned criteria, compared to combined conventional tests. Compared to the use of single cardiolipin tests, the DETERMINE^® test detected 27.1% more cases. False positive tests with DETERMINE Syphilis TP test occurred 0.26% of those patients tested.

Conclusions The DETERMINE^® syphilis test is superior to treponemal and cardiolipin tests alone or in combination in the detection of syphilis in Primary Care.