Analysis of the Operational Costs of Using Rapid Syphilis Tests for the Detection of Maternal Syphilis in Bolivia and Mozambique CAROL E. LEVIN, PHD,* MATTHEW STEELE, PHD, MPH,* DEBORAH ATHERLY, RPH, MPH,* SANDRA G. GARCı´A, SCM, SCD,† FREDDY TINAJEROS, MPH,‡ RITA REVOLLO, MD, MPH,‡ KARA RICHMOND, MPH,§ CLAUDIA Dı´AZ-OLAVARRIETA, PHD,† TOM MARTIN, MPH,  FLORENCIA FLORIANO,¶ ISABEL MASSANGO,** AND STEPHEN GLOYD, MD, MPH†† Objective: The objective of this study was to compare the costs of antenatal syphilis screening with the rapid plasma reagin (RPR) test and the immunochromatographic strip (ICS) test in low-resource settings. Goal: The goal of this study was to assess the costs of introducing rapid syphilis tests to reduce maternal and congenital syphilis. Study Design: Cost data were collected from participating study hospitals and antenatal clinics during 4 field visits to the 2 countries in 2003 and 2004. Health utilization outcome data on the number of women screened and treated routinely during the demonstration projects were used with unit cost data to estimate the incremental costs and average cost per woman screened and treated for maternal syphilis. Results: In Mozambique, the average cost per woman screened was U.S. $0.91 and U.S. $1.05 for the RPR and ICS tests, respectively. In Bolivia, the average cost of screening was U.S. $1.48 and U.S. $1.91 using the RPR and ICS test, respectively. In health centers without laboratories, the cost per woman screened using the ICS test ranged from U.S. $1.02 in Mozambique to U.S. $2.84 in Bolivia. Conclusions: It is feasible to introduce rapid syphilis testing in settings without laboratory services at a small incremental cost per woman screened. In settings with laboratories, the cost of ICS is similar to that of RPR. SYPHILIS IS A MAJOR CAUSE of adverse pregnancy outcomes in women and also an important cofactor for HIV acquisition and transmission in the developing world. Management of maternal syphilis relies on serologic screening in pregnancy and treatment with injectable penicillin. If left untreated, syphilis infection can lead to stillbirth, neonatal death, premature delivery, or congenital syphilis among newborns. Commonly, rapid plasma reagin (RPR) testing is carried out that identifies antibodies to phospholipid antigens on the surface of treponemes. This test is relatively easy to perform and has adequate sensitivity during early stages of infection. However, it does rely on basic laboratory equipment and may yield false-positive and -negative results depending on anti- body presentation, the stage of infection, and carriage of other treponemal infections. 1 In some cases, a positive screening test result with RPR will necessitate a second confirmatory test to prove that the treponemal infection is in fact syphilis. Rapid tests, those that can be performed with minimal equipment and skill and provide a result at the point of care, are now commonly available for screening pregnant women for syphilis. 2,3 These tests, which are based on lateral flow immunochromatographic strip (ICS) platforms, detect specific syphilis treponemal antibodies similar to those used in confirmatory tests such as Treponema pallidum hemagglutination assay (TPHA) or T. pallidum particle agglutina- tion (TPPA). 1 The advantages of these rapid tests are that they are generally inexpensive, require no laboratory instrumentation and little training, and can be administered at the point of care, which allows for rapid diagnosis and treatment. The disadvantages of these rapid syphilis tests are that they do not distinguish between recent/current or historical infection because the antibodies are long-lived in the human body. Both the RPR and ICS rapid tests represent strategies for screen- ing pregnant women for syphilis infections. It is unclear which strategy yields the most efficient diagnosis and treatment per unit investment given the monetary, human resource, and opportunity costs associated with each test. Recent studies in sub-Saharan Africa have shown that an antenatal syphilis screening and treat- ment program using the RPR test is a very cost-effective interven- tion and provides good value for the investment. In Tanzania, the cost-effectiveness of antenatal syphilis screening using RPR was $10.56 per disability-adjusted life-year (DALY) saved. Data from other studies conducted in Zambia and Kenya provided cost- effectiveness estimates of $3.97 per DALY averted in Zambia and between $9.57 and $9.84 per DALY averted in Kenya (all costs are presented in 2001 U.S. dollars). 4 Unfortunately, there are currently no published data on the cost-effectiveness of using rapid ICS tests as part of antenatal syphilis screening programs. Yet, there is an The authors thank Health Alliance International and the Population Council Regional Office for Latin America who made the collaboration possible as well as the Bill & Melinda Gates Foundation for their support of this work. The authors are grateful to the many individuals who contributed to the success of this project, including Pablo Montoya and Noe Nhantumbo in Mozambique and Monica Gironas, Nayrha Villazon, and Carolina Montes in Bolivia. Thanks also go to the many nurses and public health officials who provided information and insights on syphilis screening in antenatal settings in Bolivia and Mozambique. The authors also thank 3 anonymous reviewers for their valuable comments. Correspondence: Carol Levin, PhD, PATH, 1455 NW Leary Way, Seattle, WA 98107. E-mail: clevin@path.org. Received for publication May 11, 2006, and accepted September 6, 2006. From *PATH, Seattle, Washington; †The Population Council, Regional Office for Latin America and the Caribbean, Mexico City, Mexico; ‡The Population Council, Bolivia–La Paz, Bolivia; §Independent consultant, Albuquerque, New Mexico; the International Health Program, Department of Health Services. University of Washington, Seattle, Washington; ¶Health Alliance International, Beira, Mozambique; the **Ministry of Health, Division of Maternal and Child Health, Beira, Mozambique; and ††Health Alliance International, Seattle, Washington Sexually Transmitted Diseases, December 2006, Vol. 33, No. 12, p.000 – 000 DOI: 10.1097/01.olq.0000245986.62775.b6 Copyright © 2006, American Sexually Transmitted Diseases Association All rights reserved. 1