RESUMEN
INTRODUCTION: Globally, the incidence of HIV and syphilis can be reduced by the use of validated point of care tests (POCTs). As part of the WHO PRoSPeRo Network, we aimed to evaluate the performance, acceptability, and operational characteristics of two dual HIV/syphilis POCTs (Bioline HIV/Syphilis Duo (Abbott) and DPP® HIV-Syphilis assay (Chembio) for the screening of HIV and syphilis amongst men who have sex with men (MSM). METHOD AND ANALYSES: A cross sectional study of 2,577 MSM in Italy, Malta, Peru, and the United Kingdom (UK) presenting to seven clinic sites, were enrolled. Finger prick blood was collected to perform POCTs and results compared with standard laboratory investigations on venepuncture blood. Acceptability and operational characteristics were assessed using questionnaires. Diagnostic meta-analysis was used to combine data from the evaluation sites. RESULTS: Based on laboratory tests, 23.46% (n = 598/2549) of participants were confirmed HIV positive, and 35.88% of participants (n = 901/2511) were positive on treponemal reference testing. Of all participants showing evidence of antibodies to Treponema pallidum, 50.56% (n = 455/900) were Rapid Plasma Reagin (RPR) test reactive. Of HIV positive individuals, 60.62% (n = 354/584) had evidence of antibodies to T. pallidum, and of these 60.45% (n = 214/354) exhibited reactive RPR tests indicating probable (co)infection. For Bioline POCT, pooled sensitivities and specificities for HIV were 98.95% and 99.89% respectively, and for syphilis were 73.79% and 99.57%. For Chembio pooled sensitivities and specificities for HIV were 98.66% and 99.55%, and for syphilis were 78.60% and 99.48%. Both tests can detect greater than 90% of probable active syphilis cases, as defined by reactive RPR and treponemal test results. These dual POCTs were preferred by 74.77% (n = 1,926) of participants, due to their convenience, and the operational characteristics made them acceptable to health care providers (HCPs). CONCLUSIONS: Both the Bioline and the Chembio dual POCT for syphilis and HIV had acceptable performance, acceptability and operational characteristics amongst MSM in the PRoSPeRo network. These dual POCTs could serve as a strategic, more cost effective, patient and healthcare provider (HCP) friendly alternative to conventional testing; in clinical and other field settings, especially those in resource-limited settings.
Asunto(s)
Infecciones por VIH , Minorías Sexuales y de Género , Sífilis , Masculino , Humanos , Sífilis/diagnóstico , Sífilis/epidemiología , Homosexualidad Masculina , Perú/epidemiología , Malta , Estudios Transversales , Treponema pallidum , Pruebas en el Punto de Atención , Serodiagnóstico de la Sífilis/métodos , Sensibilidad y Especificidad , Anticuerpos Antibacterianos , Infecciones por VIH/diagnóstico , Infecciones por VIH/epidemiologíaRESUMEN
BACKGROUND: Both the global incidence and the prevalence of sexually transmitted infections (STIs) continue to increase, affecting hundreds of millions of individuals, particularly in low-to middle-income countries. Although a definitive diagnosis is desirable to inform STI treatment, syndromic management is the most widely used strategy in resource-limited settings. With the development of point-of-care (POC) tests, it is important to discuss how laboratories will need to adapt to new training and supervisory roles in support of testing, which will largely be performed by peripheral clinical staff. OBJECTIVES: To discuss potential applications of STI POC tests, how they could improve existing STI control strategies and the role of clinical and reference laboratories in support of initiatives to improve STI management and control activities. SOURCES: Narrative literature review and expert opinion. CONTENT: The paper outlines the current status of the STI epidemic worldwide and discusses the problems associated with current approaches to control these infections, particularly in low-resource settings. The roles of clinical and reference laboratories will need to change to provide support for POC and near-patient STI testing as these technologies are introduced into clinical as well as laboratory settings. IMPLICATIONS: Laboratories will be expected to play a leading role in the introduction and implementation of POC and near-patient STI testing. They will be required to facilitate training and provide technical and supervisory support to clinical staff on the use of these technologies to augment existing STI management and surveillance programmes. In order to provide quality service, they will need to develop, introduce and maintain sustainable local quality control and external quality assurance systems. Evidence from implementation research for introduction and scale up of STI POC tests in different STI epidemic and laboratory infrastructure settings is required.
Asunto(s)
Infecciones por VIH , Enfermedades de Transmisión Sexual , Infecciones por VIH/epidemiología , Humanos , Laboratorios , Pruebas en el Punto de Atención , Enfermedades de Transmisión Sexual/diagnóstico , Enfermedades de Transmisión Sexual/tratamiento farmacológico , Enfermedades de Transmisión Sexual/epidemiologíaRESUMEN
In Peru, a significant proportion of people tested for HIV and syphilis do not receive timely results. Our objective was to assess the institutional feasibility of implementing simultaneous HIV/syphilis point-of-care tests and client perceptions regarding these point-of-care tests. Point-of-care tests were implemented in a hospital consultation room in a marginalised zone of Lima. A time-series design was used to compare the proportion of tested clients who received timely results, with and without the point-of-care test intervention. Experience and satisfaction with point-of-care tests was evaluated with 149 people. In the 6 months without intervention, 69% and 61% of clients tested for HIV and syphilis, respectively, received their results within the required 45-minute window. During the 2-month point-of-care test intervention, all clients tested for HIV (n = 387) and syphilis (n = 398) received their results within 45 minutes. All clients surveyed were completely satisfied (52%) or satisfied (48%) with the simultaneous HIV/syphilis point-of-care test screening process. Additionally, 73% strongly agreed with the statement 'I feel satisfied with the rapid testing process.' Screening using point-of-care tests represents an important opportunity to reduce the time, resource and cost burden for users and institutions and increase the proportion of users receiving their test results in a timely manner.