Malawi has made remarkable strides towards the UNAIDS 95-95-95 goals, achieving 94%-99%-93% by March 2022. In the last four years, AMPLIFY’s technical assistance to the Ministry of Health (MoH) contributed significantly to Malawi’s success in achieving those goals. Specifically, expanding Malawi’s laboratory network, including 14 conventional laboratories and 153 point-of-care testing (POCT) sites, was critical for HIV diagnosis, treatment, and monitoring and was leveraged to support diagnostics during the COVID-19 pandemic. AMPLIFY partnered with MoH to establish quality management systems (QMS) mentors, improve QMS, and make history by accrediting nine laboratories and having two additional laboratories recommended for accreditation. AMPLIFY and MoH increased QMS implementation in lower-level facilities, expanding Stepwise Process for Improving the Quality of HIV (SPI) POCT and SPI RT (rapid testing) to 100% of the sites and increasing the number of certified RT sites by 200%. For further quality improvement and sustainability, AMPLIFY built MoH’s capacity to locally produce proficiency testing (PT) panels for 13 tests, established an electronic management system, and improved site participation and performance. To improve data capture, use, and interoperability at conventional laboratory, hub, and POCT levels, AMPLIFY collaborated with partners to integrate the laboratory information system (LIMS) with all conventional testing equipment, electronic medical record (EMR) system, and POCT instruments, and developed a sample reception module to increase visibility and decrease turn-around-time. Together with enhanced routine monitoring and evaluation, these tools equipped the MoH to make informed decisions and optimally leverage resources.
The proposed AMPLIFY 2.0, led by the Center for International Health, Education and Biosecurity (Ciheb) Initiative, a local nongovernmental organization, keeps the successful momentum while safeguarding the gains and addressing any gaps. AMPLIFY 2.0 brings together a consortium of local and international organizations and experts with >15 years of combined experience working with the MOH and over 30 years of combined experience in lab strengthening in Africa. Under the leadership of the local prime, Ciheb Initiative, University of Maryland Baltimore (UMB) that led AMPLIFY, supported by a trained and competent Malawian staff on the ground, will provide TA across all areas of implementation. The African Society for Laboratory Management (ASLM) will build sequencing capacity and establish accredited services for clinical lab accreditation, PT provider accreditation, and equipment calibration. AMPLIFY 2.0 will continue transformative partnerships with MOH, National Reference Laboratory, Public Health Institute of Malawi (PHIM), and PEPFAR Sample Transport, Clinical Service, and Health Informatics partners.
In the next five years, AMPLIFY 2.0 will produce timely and multi-disease testing services; test 95% of VL, EID, TB, Pre-Exposure Prophylaxis, and Advanced HIV Disease samples and dispatch results on time; optimize the diagnostic network; enhance appropriate biosafety and waste management; obtain additional ISO15189/ISO17043 accreditations in testing and PT panel producing laboratories; enroll PEPFAR priority tests into the EQA program with a 90% pass rate; and expand HIV RTCQI activities for national certification. To achieve this, AMPLIFY 2.0 will: 1) scale up multi-disease and integrated diagnosis monitoring by leveraging current relationships with MoH and clinical IPs; integrating testing across all levels of the lab while optimizing equipment use and staffing, and expanding and strengthening LIMS; 2) strengthen biosafety and biosecurity; 3) strengthen MoH capacity to coordinate and oversee diagnostics services, increase capacity of the workforce; 4) partner with ASLM to build capacity in gene sequencing and establish accredited calibration and accreditation services.