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      Performance of rapid syphilis tests in venous and fingerstick whole blood specimens.

      Sexually Transmitted Diseases
      Adult, Ambulatory Care Facilities, Female, Hemagglutination Tests, Humans, Male, Predictive Value of Tests, Reagent Kits, Diagnostic, San Francisco, Sensitivity and Specificity, Syphilis, blood, diagnosis, prevention & control, Syphilis Serodiagnosis, methods

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          Abstract

          Rapid syphilis screening could facilitate case-identification during U.S. outbreaks. The goal of this study was to determine the performance of 3 rapid syphilis tests in whole blood specimens in the laboratory and in patients at a sexually transmitted disease (STD) clinic. We tested whole blood samples from STD clinic patients with 3 rapid tests and compared results with the serum treponemal pallidum particle agglutination (TP-PA) test. We evaluated the best performing of the 3 rapid tests on fingerstick specimens from STD clinic patients. The Abbott Determine TP (n = 127) had the highest sensitivity (88%; 95% confidence interval [CI], 81-96%) and lowest rate of indeterminate tests (0.8%), followed by Guardian Biosciences One Step (n = 116) (sensitivity 72%; 95% CI, 60-84%; indeterminate 6.5%), and Phoenix Biotech Trep-Strip IV (n = 71) (sensitivity 70%; 95% CI, 54-85%; indeterminate 30.3%). All 3 tests were 100% specific. The Abbott Determine TP showed excellent performance on fingerstick specimens (n = 99), exhibiting 100% sensitivity (95% CI, 93-100%), 100% specificity, and 2.9% indeterminate. The Abbott Determine TP test was an easy and accurate test that could facilitate rapid detection of syphilis in at-risk patients.

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