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.

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.