EDCTP capacity building achievements at the International Centre For Reproductive Health (ICRH) clinical research laboratory in Mombasa, Kenya

Abstract

Introduction | Guaranteeing the capacity of laboratories to generate reliable and accurate data is vital for successful clinical research. Capacity strengthening is not only acquisition of modern equipment and reagents but also sustained commitment to training, quality, and biosafety. Through an EDCTP capacity building grant, ICRH-Kenya undertook projects to improve clinical trial capacity. Key laboratory capacity building activities are summarised. Methods | A holistic approach was taken to strengthen infrastructure, equipment, training, and testing capacity. Local and/or sustainable solutions were preferred and were executed with GCLP-compliance and a long-term goal of accreditation in mind. Results | A spacious building was refurbished to house the laboratory, and then equipped with an access control system, reliable electricity and water backups, a state-of-the-art communication infrastructure serving staff and a temperature e-monitoring system. Equipment acquired includes: ultra low temperature freezers fitted with temperature e-monitoring auto-dial system, autoclave, real-time and conventional thermal cyclers. Training designed to establish capacity so that the laboratory is subsequently able to do/renew its own trainings, was done on biosafety, quality management systems, and GCLP. High-quality tests for chlamydia, gonorrhoea, HSV-2, HIV-1 viral load, and HPV genotyping, among others, were set up. Conclusion | Overall, the laboratory experienced manifest capacity growth resulting in augmented staff competence and confi dence and an expanded test repertoire. Improved appreciation of safety and quality led to the formation of a safety committee, and the preparation of safety and quality manuals. With good foresight and management, capacity building grants can have lasting impact in resource-poor settings.