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THP 77 Comparative Test Performance of Seven Treponemal Tests for Diagnosis of Syphilis

Thursday, September 22, 2016
Galleria Exhibit Hall
Ina Park, MD, MS1, Yetunde Fakile, PhD2, Susan Novak, PhD3, Jeffrey Schapiro, MD4, Anthony Tran, DrPH, MPH5, Katie Gustafson, BA6, Jim Nomura, MD7, Karen Hoover, MD8 and Joan Chow, MPH, DrPH1, 1Sexually Transmitted Disease Control Branch, California Department of Public Health, Richmond, CA, 2Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 3Kaiser Permanente Southern California Regional Laboratory, 4Kaiser Permanente Northern California (KPNC) Regional Laboratory, Berkeley, CA, 5New York City Department of Health and Mental Hygiene, 6California Department of Public Health STD Control Branch, 7Kaiser Permanente Los Angeles Medical Center, 8Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA

Background:  Newer enzyme or chemiluminescence immunoassays (EIA/CIAs) are increasingly used for syphilis screening, and are often confirmed with traditional treponemal tests (Treponema pallidum particle agglutination assay, TP-PA, or fluorescent treponemal antibody absorbed test, FTA-ABS).  Test performance of treponemal EIA/CIAs compared to traditional tests is not well understood.   

Methods:  We conducted a cross-sectional analysis comparing sensitivity and specificity of five treponemal immunoassays (Trep-Sure EIA, Advia Centaur Syphilis, Bioplex 2200 Syphilis, LIAISON Treponema, INNO-LIA Syphilis) and two traditional treponemal tests (TP-PA, FTA-ABS).    Specimens were obtained from Kaiser Permanente Southern California, Kaiser Permanente Northern California and San Francisco Department of Public Health from 5/2012-1/2013.  Gold-standard case definitions were determined utilizing serology and chart review data and included: 1) current syphilis:  clinical diagnosis based on history, signs/symptoms, and laboratory findings, 2) prior syphilis: prior history documented but no current syphilis, 3) not syphilis: no current or prior syphilis in last 2 years, no prior positive syphilis serology, and at least 5/7 serology tests negative. 

Results:  Among 855 participants, 262 had current syphilis, 328 had prior syphilis, and 265 did not have syphilis. Among the seven assays, TP-PA had the highest specificity, (100 %, 98.6-100).  Trep-Sure EIA was the most sensitive at detecting current syphilis (98.5%, 96.1-99.6), but had significantly lower specificity than the other assays (76.1%, 70.4-81.1).  The FTA-ABS was the least sensitive (90.8%, 86.7-94.0) but was highly specific (97.4%, 94.6-98.9).  TP-PA, Bioplex 2200, INNO-LIA, and Centaur demonstrated both sensitivities and specificities >95%. 

Conclusions:  Among traditional treponemal tests, TP-PA demonstrated superior sensitivity and specificity to FTA-ABS and would be preferred to confirm reactive EIA/CIA results.  Utilizing a second EIA/CIA with high sensitivity and specificity (>95%) would be a reasonable alternative approach to using a traditional treponemal test.  These data have implications for laboratories to inform selection of treponemal assays for syphilis screening and diagnosis. 

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