Integrated Testing for TB and HIV using GenExpert Devices Expands Access to Near-Point-of-Care Testing

This brief summarizes lessons learned from Zimbabwe’s pilot implementation of integrated or multi-disease testing. Partnerships in the country focused on leveraging existing GeneXpert platforms for both TB and HIV testing to improve access to early infant HIV diagnosis and viral load testing. These findings describe the benefits of integrated testing for clients, health providers and the health system and are a resource for other countries scaling up point-of-care integrated testing.

Accelerating Access to Point-of-Care Viral Load Testing for Pregnant and Breastfeeding Women Living With HIV

This brief highlights the current scenario of policies and programmes related to point-of-care viral load testing among pregnant and breastfeeding women living with HIV. In many countries, viral load policies are not differentiated for pregnant and breastfeeding women despite evidence that point-of-care viral load testing is helpful for this population. Same-day results for pregnant and breastfeeding women can help ensure timely initiation of ART, improved rates of viral suppression and retention in care to support efforts of preventing vertical transmission of HIV.

Quality Assurance Costing Tool

This excel-based tool is designed to help countries model the cost of a comprehensive quality assurance (QA) program. It is composed of eight approaches to providing QA for diagnostic equipment: mentorship; external quality control proficiency testing (international and national); duplicate testing; data management through connectivity; paper-based external quality assurance; and e-modules. 

Author: CHAI
Year: 2017

Site Monitoring Guidance and Checklists

Regular monitoring of POC EID implementation sites is crucial for ensuring the quality and efficacy of site-level operations throughout the project. Site monitoring visits will provide essential insights into site-level issues related to human resources, patient flow, platform functioning, end user performance, specimen transport, data, data quality, and capacity building needs of site level staff.

Author: EGPAF

Year: 2017

Post-Market Surveillance

Post-market surveillance aims to ensure that IVDs continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. WHO has developed normative guidance on post-market surveillance of in vitro diagnostics, emphasizing the importance of both reactive post-market surveillance and proactive post-market surveillance activities.

Reactive post-market surveillance refers to activities undertaken after an issue has occurred related to the IVD test (e.g., complaint reporting/monitoring; end user quality control programs, etc.), whereas proactive post-market surveillance refers to scans for potential issues related to the IVD (e.g., pre- and/or post-distribution lot testing). Lot testing involves testing samples from a manufacturing lot to ensure performance meets an acceptable standard.

For additional information on post-market surveillance, including sample reporting forms, see http://www.who.int/diagnostics_laboratory/postmarket/en/

Connectivity Brief POC - French

Les tests de diagnostic décentralisés réalisés au moyen de plates-formes présentes sur les lieux de soins ou à proximité peuvent considérablement améliorer les soins prodigués aux patients en élargissant l’accès à des services de diagnostic essentiels, en réduisant les délais d’obtention des résultats et en améliorant l’intégration aux soins.

Connectivity Brief for POC

Decentralized diagnostic testing using point-of-care (POC) or near-POC platforms can significantly improve patient care by expanding access to critical diagnostic services, reducing result turnaround time (TAT), and improving linkage to care.