Enhancing availability of quality diagnostic tests

Diagnostic testing plays a critical role in primary patient care, assisting health care providers in preventing, detecting, and responding to current and emerging infectious diseases like HIV/AIDS, tuberculosis, malaria, and COVID-19.

Diagnostic testing also provides important health screening and treatment monitoring, including viral load testing, improves emergency preparedness for outbreaks, and helps policymakers make informed public health decisions.

We increase access to quality-assured diagnostics by assisting medical diagnostic and medical device quality control laboratories in achieving and maintaining global accreditation, supporting manufacturers to produce quality-assured diagnostics, and strengthening regulatory capabilities to review, approve, and monitor medical devices.

A fast-track approach to global accreditation

Building on our deep experience of strengthening more than 90 national quality control laboratories worldwide, we help countries develop better quality management systems (QMS) and carve out a faster path to accreditation than traditional approaches, usually within 12-18 months. Our diagnostic laboratory engagement typically begins with an initial assessment using the Stepwise Laboratory Quality Improvement Towards Accreditation (SLIPTA) checklist from the World Health Organization (WHO) while aligning the laboratory with ISO 15189 accreditation requirements through a rapid, integrated, and collaborative approach (RICA).

Resources

White paper: Expanding the capacity to produce vaccines in Africa (February 2023)

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