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Use of automated testing in syphilis diagnosis and its impact on surveillance – Connecticut, 2010 Kelley Bemis CDC/CSTE Applied Epidemiology Fellowship STD Control Program Connecticut Department of Public Health [email protected] Background National Plan to Eliminate Syphilis implemented Graph: Together We Can SEE: The National Plan to Eliminate Syphilis, CDC, 2006 Primary and Secondary Syphilis Cases 2002 - 2010 Connecticut Incidence 2010 Goal for National Incidence National Incidence Crude Incidence Per 100,000 5.00 4.50 National elimination plan reframed 4.00 3.50 3.00 2.50 2.00 1.50 +177% from 2008 to 2010 1.00 0.50 0.00 2002 2003 2004 2005 2006 Years 2007 2008 2009 2010 Syphilis Surveillance Crucial for syphilis elimination • • Identify infectious patients (laboratory confirmed) for partner notification Identify outbreaks and target interventions Mainly laboratory reporting • • Labs must report positive tests in 48 hours Mail reports to DPH Understanding laboratory testing is necessary for accurate surveillance Syphilis Diagnosis Usually two serologic tests Non-specific test • e.g. rapid plasma reagin test (RPR), Venereal Disease Research Laboratory test (VDRL) • Detects antibodies against host lipoidal antigens • Indicates active infection • Inexpensive, simple, manual Specific test • • • e.g. T. pallidum particle agglutination (TPPA), fluorescent treponemal antibody absorption assay (FTA-ABS) Detects antibodies against treponemal antigens Indicates infection, past or present Traditional Screening Algorithm Non-specific test (RPR or VDRL) - + Specific test (TPPA or FTAABS) + Syphilis Syphilis unlikely Syphilis unlikely Challenge for Surveillance #1 Positive test ≠ Active infection One positive doesn’t confirm infection • Surveillance must monitor for two positives Non-specific titers vary with age and stage of infection • Surveillance must consider past test results and likelihood of infectiousness Challenge for Surveillance #2 A shift in testing paradigm: Automated treponemal tests for screening Treponemal EIAs and CIAs gaining popularity More expensive but less manual labor needed Still can’t distinguish between active and past infection Photo credit: Reverse Sequence Syphilis Screening Webinar, CDC, 2011 Reverse Sequence Screening Algorithm EIA or CIA - + Non-specific test (RPR or VDRL) Syphilis unlikely Not identified with traditional algorithm - + Specific test (TPPA) Syphilis + Syphilis (old or new) Syphilis unlikely (or do another specific test) 1. 2. 3. False positive EIA or CIA Previously treated syphilis Early primary syphilis Challenge for Surveillance #2 Increased testing volume New questions for surveillance • • How should EIAs and CIAs be reported? Should discordant results be investigated? Increased DPH workload Objectives To conduct a laboratory-focused evaluation of syphilis surveillance in Connecticut Determine type and volume of syphilis testing performed by Connecticut laboratories Determine if current surveillance procedures adequately monitors reported tests for infectious cases Methods, Part 1 Laboratory Survey Web survey emailed to all hospital and commercial labs in Connecticut (n=30) • • • Number of tests performed in 2010 Testing algorithm Reporting practices Responses analyzed with descriptive statistics Methods, Part 2 Laboratory Audit Requested records from two commercial laboratories • All patients with a positive test in 2010 Compared against records in state’s surveillance database Investigated selection of tests missing from state’s database Laboratory Survey Results 30 of 30 (100%) labs completed the survey 28 of 30 (93%) perform syphilis testing Over 196,700 screening tests performed in 2010 Uptake of Automated Tests Number of Laboratories 30 25 20 15 24 10 5 0 4 Using automated Using manual tests tests Number of Laboratories Referring Samples is Common 16 14 12 10 8 9 15 6 4 4 2 0 Refers samples for confirmatory testing Labs Using Automated Tests Does not refer samples Labs Using Manual Tests Number of laboratories Reporting Results 16 14 12 10 8 11 13 6 4 2 3 1 0 Reports both test results* Labs Using Automated Tests Does not report both test results Labs Using Manual Tests Laboratory Audit Results Lab A Lab B Screens with a VDRL Screens with an EIA Confirms with a FTAABS RPR and FTA-ABS reported RPR and TPPA reported 693 (56%) of 1241 positive reportable tests were not in the state’s database 372 (29%) of 1299 positive reportable tests were not in the state’s database Confirms all +’s with RPR and TPPA Laboratory Audit Results Small sample of missing tests investigated from both labs Lab A Lab B • Random sample (n=35 patients) representing different months, tests, and titers • All patients with both RPR and TPPA missing (n=13) Most patients did not merit field investigation We concluded that entry into state database is not consistent for these tests Conclusions Uptake of automated tests is moderate, but increasing Automated testing algorithms are variable Referring specimens is common Labs do not always report both types of tests used for diagnosis Standard protocols for entering lab tests do not exist or are not enforced Recommendations Create protocols for entering tests into the surveillance database • • • All non-specific tests are entered Treponemal results may be entered only once Negative tests will be entered if reported Recommendations Establish provisional procedures for monitoring EIA/CIA’s and discordant results • • EIA/CIA’s do not need to be reported unless a manual treponemal test was not performed Discordant results will not be investigated Recommendations Offer training on interpretation of EIA/CIA’s • • Internal meetings with DPH Disease Intervention Specialists (DIS) Newsletters to local health epidemiologists and clinicians Recommendations Offer training on reporting requirements to laboratories • Newsletter to Laboratory Response Network Acknowledgments Virginia Kristie, MT ASCP Mark Lobato, MD Lynn Sosa, MD Connecticut laboratories This study was supported in part by an appointment to the Applied Epidemiology Fellowship Program administered by the Council of State and Territorial Epidemiologists (CSTE) and funded by the Centers for Disease Control and Prevention (CDC) Cooperative Agreement Number 5U38HM000414. Extra Slides Reporting of Referral Samples From the OLC-15 Reporting Form: From the Public Health Code: Test Sensitivity and Specificity Credit: Seña, A.C., White, B.L. & Sparling, P.F. Novel Treponema pallidum Serologic Tests: A Paradigm Shift in Syphilis Screening for the 21st Century. CID 51, 700-708 (2010). EIA/CIA Algorithms in Connecticut EIA + RPR & TPPA EIA + RPR - TPPA & EIA x2 CIA CIA + + RPR RPR - TPPA Sero-reactivity in Syphilis Tests Credit: Peeling et al. / Bulletin of the World Health Organization / 2004 / Vol. 82 / No. 6 via CDC Reverse Sequence Screening Webinar