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P188 Field Evaluation of Dried Tube Specimens for Syphilis Rapid Point of Care Test Proficiency in Suba District, Kenya

Wednesday, March 14, 2012
Hyatt Exhibit Hall
Kathryn Lupoli, BS1, Jared Oremo2, Tun Ye, MBBS, PhD3, Mary Kamb, MD, MPH1, Steve Kola2, Maureen Kelley4 and Sadumah Ibrahim5, 1Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 2Safe Water and Aids Project, Kisumu, Kenya, 3Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, 4School of Nursing, Emory University, Atlanta, GA, 5Great Lakes University of Kisumu Kenya, Kisumu, Kenya

Background:  Point-of-care rapid syphilis tests are especially useful in low-income countries. A national proficiency testing program for syphilis rapid tests is essential to ensure accurate diagnosis and prompt treatment of syphilis.

Objectives:  To assess the feasibility of  implementing a proficiency testing program using dried tube specimens (DTS) to ensure the quality of rapid syphilis testing.

Methods:  RPR and TP-PA characterized syphilis reactive serum was used to make dilutions yielding strong, medium, and faint reactivities. For each, 20µL aliquots were allowed to air dry overnight. DTS panels were created by blinding each reactivity group. DTS panel kits were distributed to 21 hospital, clinic, and dispensary sites. The 40 participants tested the panel samples using the SD Bioline Syphilis 3.0 rapid test and recorded the reactivity strength of each specimen. Participant results were scored using the Reference Laboratory DTS Panel ID key.

Results:  For strongly reactive panels, 80% (32/40) of participants correctly identified the panel strength, with 1 participant misidentifying the serum as negative and 7 as either medium or faint. For the moderately reactive panels, 65% (26/40) of participants correctly identified the medium strength, and none reported it as negative. For the faintly reactive panels, 68% (27/40) of participants correctly identified the panel strength as faint with 8% (3/40) identifying it as negative. For the negative panels, 63% (25/40) of participants correctly identified the panel strength, with the remaining 37% reporting it as either strong, medium, or faint. 

Conclusions:  Overall, the positive predictive value of the DTS was high with 88% of the strong, moderate, or faintly reactive panels read as positive; however, the negative predictive value was low (26%).

Implications for Programs, Policy, and Research:  Implementing a national proficiency testing program for syphilis rapid tests using DTS is feasible; however, ongoing training and oversight on negative tests could further aid the program.

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