Evaluation of seven rapid tests for syphilis available in Brazil using defibrinated plasma panels

Maria Luiza Bazzo, Leonardo Rapone da Motta, Renata Cristina Messores Rudolf-Oliveira, Alisson Bigolin, Lisléia Golfetto, Fábio Mesquita, Adele Schwartz Benzaken, Pamela Cristina Gaspar, Ana Flavia Nacif P Coelho Pires, Orlando da Costa Ferreira Júnior, Miriam Franchini
2017 Sexually Transmitted Infections  
Objectives In 2012, the WHO estimated that 6 million new cases of syphilis per year would occur worldwide, including 937 000 in Brazil. Early diagnosis and treatment of syphilis are essential to reduce morbidity and prevent transmission. The availability of rapid tests (RTs) for this diagnosis means that testing can be performed more quickly, as a point-of-care test, even in non-laboratory environments and requires only simple technical training to antibodies detection. The objective of this
more » ... dy was to evaluate the performance and operational aspects of seven commercially available RTs for syphilis in Brazil. Methods Seven rapid treponemal tests were evaluated for sensitivity, specificity, accuracy and Kappa value, according to a panel composed of 493 members. The operational performance of the assay was also determined for these tests. results The seven RTs showed sensitivity ranging from 94.5% to 100% when compared with the reference tests and specificity of between 91.5% and 100%. All the RTs evaluated presented good operational performance, and only one failed to present the minimum specificity as defined by Brazil's Ministry of Health. conclusion All the tests presented good operational performance, and the professionals who performed them considered them to be easy to use and interpret. This evaluation is important for making informed choices of tests to be used in the Brazilian Unified Health System. IntrOductIOn Syphilis constitutes a major public health problem. In 2012, the WHO estimated that six million new cases of syphilis per year would occur worldwide. 1 Between 2014 and 2015, Brazil experienced an increase of 32.7% in acquired syphilis and 21.0% in congenital syphilis. 2 arly diagnosis and treatment of syphilis are essential to reduce morbidity and prevent vertical transmission (congenital syphilis), sexual transmission and further spread of the disease. 3 However, the complexity of the natural history of syphilis and the absence in many cases of specific clinical manifestations are barriers to the implementation of surveillance programme in developing countries. 4 onventional syphilis testing is usually based on serological tests, including antibodies detection by treponemal and non-treponemal tests, performed in laboratories. These tests require the training of laboratory teams. 5 In contrast, rapid tests (RTs), often referred as point-of-care tests, can be conducted by staff with minimal training at a community setting, rather than sending the sample to a laboratory. The WHO's worldwide policy to eradicate the vertical transmission of syphilis has emphasised the importance of RTs in enabling pregnant women to access diagnosis. 3 Therefore, the use of treponemal RTs is advocated for screening populations in less developed settings. The RTs can be used in a variety of situations, such as in difficult-to-reach places, for diagnosing key HIV and indigenous populations and especially for priority testing and assisting pregnant women. The availability of RTs has made it possible for syphilis testing to be done in non-laboratory environments by professionals with no laboratory experience. The objective of this study was to evaluate the performance and operational aspects of seven RTs for syphilis that are commercially available in Brazil.
doi:10.1136/sextrans-2017-053177 pmid:29223962 fatcat:kjtapq63nrf33bduok7qufipke