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Clinical and Diagnostic Laboratory Immunology, January 2004, p. 98-101, Vol. 11, No. 1
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.1.98-101.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Evaluation of the Determine Rapid Syphilis TP Assay Using Sera

Theresa Diaz,^1,2* Maria de Gloria Bonecini Almeida,² Ingebourg Georg,³ Suely de Carvalho Maia,³ Rogerio Valls de Souza,⁴ and Lauri E. Markowitz⁵

Global AIDS Program,¹ Division of STD Prevention, National Center for HIV, STD, TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia,⁵ Pan American Health Organization, Brasilia,² Immunology Service,³ Department of Infectious Diseases, Evandro Chagas Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil⁴

Received 20 May 2003/ Returned for modification 6 August 2003/ Accepted 4 November 2003

The Abbott Determine Rapid Syphilis TP assay is a treponemal test that can be used in resource-poor settings that lack laboratory facilities. However, this test has not been extensively evaluated. We measured its sensitivity and specificity by using stored serum specimens (n = 567) from all persons who tested Treponema pallidum hemagglutination assay (TPHA) positive (n = 250) or TPHA indeterminate (n = 17) in the year 2001 and the first 300 patients in 2001 who tested TPHA negative at the Evandro Chagas Research Institute in Rio de Janeiro, Brazil. This rapid assay was independently interpreted by three different observers. With TPHA results as the reference, sensitivity ranged between readers from 95.6 to 98.4% and specificity ranged from 97.3 to 95.7%. There was little interreader variability in the interpretation of results, with approximately 98% agreement for all reader combinations. Of samples from persons with human immunodeficiency virus (HIV) infection (n = 198), sensitivity was 96.9 to 99.2% and it was 94.4 to 96.3% among HIV-negative persons (n = 127). Specificity was 92.4 to 95.5% among HIV-positive persons and 97.2 to 100% among HIV-negative persons. We found this test to have high sensitivity and specificity and little interreader variability, indicating that it may be easily used in resource-poor settings without laboratory facilities. Further studies are needed using this test on whole blood and under the clinical conditions for which it is intended.

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* Corresponding author. Mailing address: Centers for Disease Control and Prevention, NCSTP, GAP, MS E30, 1600 Clifton Rd., Atlanta, GA 30333. Phone: (404) 498-2754. Fax: (404) 639-8114. E-mail: txd1{at}cdc. gov.

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Clinical and Diagnostic Laboratory Immunology, January 2004, p. 98-101, Vol. 11, No. 1
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.1.98-101.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

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