It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing.

In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of people infected with HIV to become aware of their status, access antiretroviral therapies and ultimately be virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC) testing in addition to strengthening central laboratory services. While decentralising testing increases patient access to diagnostics, it presents many challenges with regard to training and assuring the quality of tests and testing. To ensure synergies, the London School of Hygiene & Tropical Medicine held a series of consultations with countries with an interest in quality assurance and their implementing partners, and agreed on an external quality assessment (EQA) programme to ensure reliable results so that the results lead to the best possible care for HIV patients. As a result of the consultations, EQA International was established, bringing together EQA providers and implementers to develop a strategic plan for countries to establish national POC EQA programmes and to estimate the cost of setting up and maintaining the programme. With the dramatic increase in the number of proficiency testing panels required for thousands of POC testing sites across Africa, it is important to facilitate technology transfer from global EQA providers to a network of regional EQA centres in Africa for regional proficiency testing panel production. EQA International will continue to identify robust and cost-effective EQA technologies for quality POC testing, integrating novel technologies to support sustainable country-owned EQA programmes in Africa.

External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of public health microbiology laboratories, particularly for testing of epidemic-prone diseases in the African Region. These surveys revealed common issues such as supply chain management, skilled personnel, logistical support and overall lack of quality standards. For sustainable improvements to health systems as well as global health security, deficiencies identified need to be actively corrected through robust quality assurance programmes and implementation of laboratory quality management systems. Given all the pathogens of public health importance, an external quality assessment programme with a focus on vaccine-preventable diseases and emerging and re-emerging dangerous pathogens is important, and should not be stand-alone, but integrated within laboratory networks as seen in polio, measles, yellow fever and rubella. In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Prevention, the London School of Hygiene & Tropical Medicine and partners in a series of consultations with countries and national and regional EQA providers for the development of quality assurance models to support HIV point-of-care testing and monitoring. These consultations revealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forth its experience in implementing quality standards for health programmes, and also opened discussions on how lessons learned through such established programmes can be utilised to supporting and strengthening the introduction of early infant diagnosis of HIV and viral load point-of-care testing. An optimised external quality assessment programme will impact the ability of countries to meet core capacities, providing improved quality management systems, improving the confidence of diagnostic network services in Africa, and including capacities to detect events of international public health importance.

Point-of-care (POC) tests have been useful in increasing access to testing and treatment monitoring for HIV. Decentralising testing from laboratories to hundreds of sites around a country presents tremendous challenges in training and quality assurance. In order to address these concerns, companies are now either embedding connectivity in their new POC diagnostic instruments or providing some form of channel for electronic result exchange. These will allow automated key performance and operational metrics from devices in the field to a central database. Setting up connectivity between these POC devices and a central database at the Ministries of Health will allow automated data transmission, creating an opportunity for real-time information on diagnostic instrument performance as well as the competency of the operator through external quality assessment. A pilot programme in Zimbabwe shows that connectivity has significantly improve the turn-around time of external quality assessment result submissions and allow corrective actions to be provided in a timely manner. Furthermore, by linking the data to existing supply chain management software, stock-outs can be minimised. As countries are looking forward to achieving the 90-90-90 targets for HIV, such innovative technologies can automate disease surveillance, improve the quality of testing and strengthen the efficiency of health systems.

OBJECTIVE: To examine syphilis testing capacity, screening coverage rates and types of syphilis tests used in medical facilities in southern China. METHODS: Eleven of the 14 municipalities in Guangdong province participated. Data on syphilis testing capacity, screening coverage and types of syphilis tests used were collected from all types of public medical facilities offering prenatal care (n = 109). A total of 494 680 women who delivered during 2004-2008 were studied. FINDINGS: In 2008, 54 196 pregnant women (43.1%) were not screened for syphilis. Among such women, 32 863 (60.6%) attended clinics without any syphilis testing capacity and 21 333 (39.4%) attended clinics that performed testing but were not screened. The likelihood of not having syphilis test capacity was much higher for hygiene stations (odds ratio, OR: 10; 95% confidence interval, CI: 4-25), services at the township level (OR: 33; 95% CI: 10-100) and services with < 1000 deliveries per year (OR: 1.002; 95% CI: 1.001-1.003). These same service characteristics correlated with lower screening coverage rates (P < 0.01). Only one antenatal clinic had the capacity to conduct both treponemal and non-treponemal tests for diagnosing syphilis. CONCLUSION: Syphilis screening is available in very few of the basic medical facilities offering prenatal care where most neonates in southern China are delivered. In light of this and of the increasing incidence of syphilis in the area, expanding point-of-care rapid syphilis testing is a priority.

OBJETIVO: Examinar la capacidad para realizar pruebas de sífilis, evaluar las tasas de cobertura y los tipos de pruebas de sífilis utilizados en centros médicos del sur de China. MÉTODOS: Participaron once de los catorce municipios de la provincia de Guangdong. Se recopilaron datos sobre la capacidad de realizar pruebas de sífilis, la cobertura de evaluación y los tipos de pruebas de sífilis de todos los tipos de centros médicos públicos que ofrecen cuidados prenatales (n = 109). Se estudió a un total de 494 680 mujeres que dieron a luz durante el periodo 2004-2008. RESULTADOS: En el año 2008, 54 196 mujeres embarazadas (el 43,1%) no fueron evaluadas para la sífilis. De estas mujeres, 32 863 (el 60,6%) acudieron a clínicas sin capacidad para realizar pruebas de sífilis y 21 333 (el 39,4%) acudieron a clínicas que realizaban la prueba, aunque ésta no se les realizó. La probabilidad de no disponer de capacidad para realizar la prueba de sífilis era muy superior en puestos de salud (cociente de probabilidades, CP: 10; intervalo de confianza del 95%, IC: 4-25), servicios municipales (CP: 33; IC del 95%: 10-100) y servicios con < 1000 partos al año (CP: 1.002; IC del 95%: 1.001-1.003). Estas mismas características de servicio correlacionadas con tasas de cobertura de evaluación inferiores (P < 0,01). Solo seis (5,5%) tipos de servicios de cuidados prenatales tienen la capacidad de realizar pruebas treponémicas y no treponémicas para el diagnóstico de la sífilis. CONCLUSIÓN: La evaluación de la sífilis está disponible en muy pocas de las instalaciones médicas básicas que ofrecen cuidados prenatales y donde se da a luz a la mayor parte de los neonatos del sur de China. A causa de esto y del aumento de la incidencia de la sífilis en la zona, la ampliación de los puntos de asistencia para la realización de pruebas rápidas de sífilis es una prioridad.

OBJECTIF: Étudier la capacité à effectuer le dépistage de la syphilis, les taux de couverture du dépistage et les types de tests syphilitiques utilisés dans les établissements médicaux en Chine méridionale. MÉTHODES: Onze des 14 municipalités de la province de Guangdong ont participé à cette étude. Les données relatives à la capacité à effectuer le dépistage de la syphilis, à la couverture du dépistage et aux types de tests syphilitiques utilisés ont été recueillies auprès de toutes les sortes d'établissements médicaux proposant des soins prénataux (n=109). Un total de 494 680 femmes ayant accouché entre 2004 et 2008 ont fait l'objet de l'étude. RÉSULTATS: En 2008, 54 196 femmes enceintes (43,1%) n'ont pas subi le dépistage de la syphilis. Parmi ces femmes, 32 863 d'entre elles (60,6%) se sont rendues dans des cliniques ne disposant d'aucune capacité pour effectuer le dépistage de la syphilis et 21 333 d'entre elles (39,4%) n'ont pas subi de dépistage, bien qu'elles soient allées dans des cliniques aptes à le réaliser. La probabilité du manque de capacité de dépistage de la syphilis était beaucoup plus élevée pour les centres de santé (rapport des cotes, RC: 10; intervalle de confiance de 95%, IC: 4-25), les services au niveau communal (RC: 33; IC de 95%: 10-100) et les services réalisant moins de 1000 accouchements par an (RC: 1,002; IC de 95%; 1,001-1,003). Ces mêmes caractéristiques de service étaient en corrélation avec des taux de couverture de dépistage inférieurs (P<0,01). Seuls six (5,5%) types de services de soins prénataux disposaient de la capacité de mener des tests tréponémiques et non tréponémiques pour diagnostiquer la syphilis. CONCLUSION: Le dépistage de la syphilis n'est disponible que dans très peu d'établissements médicaux de base qui proposent des soins prénataux, dans lesquels la plupart des nouveau-nés de Chine méridionale voient le jour. À la lumière de ces informations et de l'incidence croissante de la syphilis dans cette région, l'extension du dépistage rapide de la syphilis aux points sanitaires est une priorité.

China is experiencing a syphilis epidemic of enormous proportions. The regions most heavily affected by syphilis correspond to regions where sexually transmitted HIV infection is also a major public health threat. Many high-risk patients in China fail to receive routine syphilis screening. This missed public health opportunity stems from both a failure of many high-risk individuals to seek clinical care and a disconnect between policy and practice. New point-of-care syphilis testing enables screening in non-traditional settings such as community organizations or sex venues. This paper describes the current Chinese syphilis policies, suggests a spatiotemporal framework (based on targeting high-risk times and places) to improve screening and care practices, and emphasizes a syphilis control policy extending beyond the clinical setting.

China está sufriendo una epidemia de sífilis de enormes proporciones. Las regiones más afectadas por esa enfermedad coinciden con aquellas donde la infección por VIH de transmisión sexual constituye también una grave amenaza para la salud pública. Muchos pacientes de alto riesgo del país no se benefician del cribado sistemático de la sífilis. Esta oportunidad perdida para la salud pública se debe tanto al hecho de que muchas personas de alto riesgo no buscan atención clínica como a la desconexión existente entre la política y la práctica. Una nueva prueba de la sífilis en el lugar de consulta permite hacer cribados en entornos no tradicionales, como por ejemplo organizaciones comunitarias o locales de sexo. En este artículo se describen las políticas aplicadas actualmente contra la sífilis en China, se sugiere un marco espaciotemporal (basado en focalizar la acción en momentos y lugares de alto riesgo) para mejorar las prácticas de cribado y atención, y se hace hincapié en una política de control de la sífilis que trascienda el ámbito de los dispensarios.

La Chine vit une épidémie de syphilis qui prend d'énormes proportions. Les régions les plus lourdement touchées par cette maladie correspondent à celles où le VIH/sida, en tant que maladie sexuellement transmissible, constitue déjà une menace importante pour la santé publique. En Chine, de nombreux individus à haut risque ne bénéficient pas d'un dépistage systématique de la syphilis. Les raisons de cette opportunité manquée pour la santé publique tiennent à la fois à l'absence de demande de soins cliniques par de nombreux individus à haut risque et à la déconnection entre politique et pratique. Le dépistage de la syphilis au niveau de nouveaux points de soins permet de dépister cette maladie dans des contextes moins classiques tels que des organisations communautaires ou des établissements sexuels. L'article décrit les politiques actuellement appliquées par la Chine contre la syphilis, propose un cadre spatiotemporel (reposant sur le ciblage des moments et des endroits à haut risque) pour l'amélioration du dépistage et des pratiques de soins et met l'accent sur une politique de lutte contre cette maladie sortant du cadre des dispensaires.

O diagnóstico e o tratamento corretos e precoces da sífilis são essenciais para o seu controle. Os testes diagnósticos tradicionais dependem de equipamentos, instalações e recursos humanos especializados. Na busca de testes de execução simplificada e rápida, realizou-se projeto de validação e da reprodutibilidade de quatro diferentes testes anteriormente avaliados pelos laboratórios de referência da Organização Mundial da Saúde. Verificaram-se também as características operacionais e aceitabilidade dos pacientes e dos profissionais de saúde. As amostras obtidas numa clínica de DST constaram de 541 e 248 pacientes com 51 e 52 positivos no FTA-Abs (padrão ouro) nos estudos 1 e 2, respectivamente. A sensibilidade variou entre 84 e 96%, especificidade superior a 98% e valor preditivo positivo > 90%. A reprodutibilidade foi superior a 97% e 0,94 no índice de kappa, comparando-se os resultados obtidos pelos diferentes profissionais. A execução dos testes foi de menos de vinte minutos, e mais de 90% dos pacientes concordaram em esperar o seu resultado até duas horas. Os testes apresentaram requisitos necessários para serem empregados no diagnóstico da sífilis, dando assim mais uma opção para o controle desta infecção.

Correct, early diagnosis and treatment of syphilis are essential for its control. Traditional diagnostic tests depend on specialized equipment, installations, and human resources. In the search for quick, simple tests, a project was conducted on the validation and reproducibility of four different tests, previously assessed by WHO reference laboratories. The study also verified the operational characteristics and acceptance by patients and health professionals. Samples obtained at an STD clinic were from 541 and 248 patients with 51 and 52 positive results according to FTA-Abs (gold standard) in studies 1 and 2, respectively. The sensitivity varied from 84 to 96%, specificity was greater than 98%, and PPV was > 90%. Reproducibility was > 97% and kappa index 0.94, comparing the results obtained by different health workers. The tests took less than 20 minutes to perform, and more than 90% of patients agreed to wait up to two hours for the results. The tests presented the necessary requirements for use in diagnosis of syphilis, thus providing an additional option for controlling this disease.

O diagnóstico e o tratamento corretos e precoces da sífilis são essenciais para o seu controle. Os testes diagnósticos tradicionais dependem de equipamentos, instalações e recursos humanos especializados. Na busca de testes de execução simplificada e rápida, realizou-se projeto de validação e da reprodutibilidade de quatro diferentes testes anteriormente avaliados pelos laboratórios de referência da Organização Mundial da Saúde. Verificaram-se também as características operacionais e aceitabilidade dos pacientes e dos profissionais de saúde. As amostras obtidas numa clínica de DST constaram de 541 e 248 pacientes com 51 e 52 positivos no FTA-Abs (padrão ouro) nos estudos 1 e 2, respectivamente. A sensibilidade variou entre 84 e 96%, especificidade superior a 98% e valor preditivo positivo > 90%. A reprodutibilidade foi superior a 97% e 0,94 no índice de kappa, comparando-se os resultados obtidos pelos diferentes profissionais. A execução dos testes foi de menos de vinte minutos, e mais de 90% dos pacientes concordaram em esperar o seu resultado até duas horas. Os testes apresentaram requisitos necessários para serem empregados no diagnóstico da sífilis, dando assim mais uma opção para o controle desta infecção.

Correct, early diagnosis and treatment of syphilis are essential for its control. Traditional diagnostic tests depend on specialized equipment, installations, and human resources. In the search for quick, simple tests, a project was conducted on the validation and reproducibility of four different tests, previously assessed by WHO reference laboratories. The study also verified the operational characteristics and acceptance by patients and health professionals. Samples obtained at an STD clinic were from 541 and 248 patients with 51 and 52 positive results according to FTA-Abs (gold standard) in studies 1 and 2, respectively. The sensitivity varied from 84 to 96%, specificity was greater than 98%, and PPV was > 90%. Reproducibility was > 97% and kappa index 0.94, comparing the results obtained by different health workers. The tests took less than 20 minutes to perform, and more than 90% of patients agreed to wait up to two hours for the results. The tests presented the necessary requirements for use in diagnosis of syphilis, thus providing an additional option for controlling this disease.

Syphilis is a major cause of adverse outcomes in pregnancy in developing countries. Fetal death and morbidity due to congenital syphilis are preventable if infected mothers are identified and treated appropriately by the middle of the second trimester. Most pregnant women with syphilis are asymptomatic and can only be identified through serological screening. Non-treponemal tests, such as the rapid plasma reagin (RPR) test, are sensitive, simple to perform, and inexpensive. However, they have often not been available at primary health-care settings because they required cold storage for reagents and electricity to operate a rotator. Additionally, as many as 28% of positive RPR results in pregnant women are biological false positives. Confirmatory assays are usually available only in reference laboratories. Technological advances have resulted in improved serodiagnostic tools for syphilis. New enzyme immunoassays are available for surveillance and for large-scale screening programmes. Decentralized antenatal screening with on-site confirmation is now possible since new RPR reagents that are stable at room temperature have become commercially available, as have solar-powered rotators and simple, rapid point-of-care treponemal tests that use whole blood and do not require electricity or equipment. These will be valuable tools for preventing or eliminating congenital syphilis. The development of a non-invasive rapid treponemal test that distinguishes between active and past infections remains a high priority in areas where syphilis is endemic.

La sífilis es una causa destacada de resultados adversos en el embarazo en los países en desarrollo. La muerte fetal y la morbilidad por sífilis congénita se pueden prevenir si se consigue identificar y tratar apropiadamente a las madres infectadas para la mitad del segundo trimestre. La mayoría de las mujeres embarazadas aquejadas de sífilis son asintomáticas y sólo pueden identificarse mediante cribado serológico. Las pruebas no treponémicas, como la prueba de reagina rápida en plasma (RRP), son sensibles, sencillas y baratas. Sin embargo, a menudo no es posible aplicarlas en los entornos de atención primaria debido a que requieren sistemas de refrigeración para los reactivos, así como electricidad para utilizar un rotador. Además, hasta un 28% de los resultados RRP positivos detectados en mujeres embarazadas eran falsos positivos biológicos. Generalmente los análisis confirmatorios sólo se pueden realizar en laboratorios de referencia. Los adelantos técnicos han permitido obtener mejores instrumentos serodiagnósticos para la sífilis. Existen nuevos inmunoensayos enzimáticos, usados con fines de vigilancia y en los programas de cribado en gran escala. El cribado prenatal descentralizado con confirmación in situ es ya posible gracias a la comercialización de reactivos de RRP estables a temperatura ambiente, así como de rotadores de energía solar y de pruebas treponémicas sencillas, rápidas y aptas para el lugar de consulta que usan sangre entera y no requieren ni electricidad ni equipo especial alguno. Estas herramientas serán de gran utilidad para prevenir o eliminar la sífilis congénita. El desarrollo de una prueba treponémica rápida no invasiva que permita diferenciar las infecciones activas y las antiguas sigue siendo una alta prioridad en las zonas con sífilis endémica.

La syphilis est une cause majeure d'issue défavorable de la grossesse dans les pays en développement. Les morts fœtales et la morbidité due à la syphilis congénitale peuvent être évitées si les mères infectées sont identifiées et traitées vers le milieu du deuxième trimestre de la grossesse. La plupart des femmes enceintes atteintes de syphilis sont asymptomatiques et ne peuvent être identifiées que par dépistage sérologique. Les tests ne reposant pas sur la recherche des tréponèmes, comme le test RPR (rapid plasma reagin) sont sensibles, faciles à exécuter et peu coûteux. Mais dans bien des cas ils n'étaient jusqu'ici pas disponibles au niveau des soins de santé primaires car les réactifs devaient être conservés au froid et une alimentation électrique était nécessaire pour l'agitateur rotatif. De plus, jusqu'à 28 % des résultats RPR positifs chez la femme enceinte sont des faux positifs dus à des causes biologiques, et les tests de confirmation ne peuvent en général être réalisés que dans un laboratoire de référence. Les progrès de la technologie ont permis d'améliorer les tests de sérodiagnostic de la syphilis. De nouveaux tests immunoenzymatiques sont maintenant disponibles pour la surveillance et pour les programmes de dépistage à grande échelle. Le dépistage anténatal décentralisé avec confirmation sur place est désormais possible depuis que de nouveaux réactifs pour le test RPR, stables à la température ambiante, sont commercialisés, de même que des agitateurs rotatifs fonctionnant à l'énergie solaire et des tests tréponémiques simples et rapides, réalisables sur place sur le sang total et ne nécessitant ni électricité ni matériel. Ces tests seront des outils précieux pour la prévention et l'élimination de la syphilis congénitale. Le développement d'un test tréponémique rapide et non invasif permettant de distinguer les infections actives des infections passées reste hautement prioritaire dans les régions où la syphilis est endémique.