Performance of a novel rapid test for recent HIV infection among newly-diagnosed pregnant adolescent girls and young women in four high-HIV-prevalence districts-Malawi, 2017-2018.

Tests for recent HIV infection (TRI) distinguish recent from long-term HIV infections using markers of antibody maturation. The limiting antigen avidity enzyme immunoassay (LAg EIA) is widely used with HIV viral load (VL) in a recent infection testing algorithm (RITA) to improve classification of recent infection status, estimate population-level HIV incidence, and monitor trends in HIV transmission. A novel rapid test for recent HIV infection (RTRI), Asanté™, can determine HIV serostatus and HIV recency within minutes on a lateral flow device through visual assessment of test strip or reader device. We conducted a field-based laboratory evaluation of the RTRI among pregnant adolescent girls and young women (AGYW) attending antenatal clinics (ANC) in Malawi.We enrolled pregnant AGYW aged <25 years testing HIV-positive for the first time at their first ANC visit from 121 ANCs in four high-HIV burden districts. Consenting participants provided blood for recency testing using LAg EIA and RTRI, which were tested in central laboratories. Specimens with LAg EIA normalized optical density values ≤2.0 were classified as probable recent infections. RTRI results were based on: (1) visual assessment: presence of a long-term line (LT) indicating non-recent infection and absence of the line indicating recent infection; or (2) a reader; specimens with LT line intensity units <3.0 were classified as probable recent infections. VL was measured for specimens classified as a probable recent infections by either assay; those with HIV-1 RNA ≥1,000 copies/mL were classified as confirmed recent infections. We evaluated the performance of the RTRI by calculating correlation between RTRI and LAg EIA results, and percent agreement and kappa between RTRI and LAg EIA RITA results.Between November 2017 to June 2018, 380 specimens were available for RTRI evaluation; 376 (98.9%) were confirmed HIV-positive on RTRI. Spearman's rho between RTRI and LAg EIA was 0.72 indicating strong correlation. Percent agreement and kappa between RTRI- and LAg EIA-based RITAs were >90% and >0.65 respectively indicating substantial agreement between the RITAs.This was the first field evaluation of an RTRI in sub-Saharan Africa, which demonstrated good performance of the assay and feasibility of integrating RTRI into routine HIV testing services for real-time surveillance of recent HIV infection.

Assessing Perceived Challenges to Laboratory Testing at a Malawian Referral Hospital.

Adequate laboratory infrastructure in sub-Saharan Africa is vital for tackling the burden of infectious diseases such as human immunodeficiency virus and acquired immune deficiency syndrome, malaria, and tuberculosis, yet laboratories are ill-integrated into the diagnostic and care delivery process in low-resource settings. Although much of the literature focuses on disease-specific challenges around laboratory testing, we sought to identify horizontal challenges to the laboratory testing process through interviews with clinicians involved in the diagnostic process. Based on 22 interviews with physicians, nurses, clinical officers, medical students, and laboratory technicians, technologists and supervisors, we identified 12 distinct challenges in the areas of staff, materials, workflow, and the blood bank. These challenges underscore the informational challenges that compound more visible resource shortages in the laboratory testing process, which lend themselves to horizontal strengthening efforts around the diagnostic process.

Informatics solutions for bridging the gap between clinical and laboratory services in a low-resource setting.

Background: There has been little formal analysis of laboratory systems in resource-limited settings, despite widespread consensus around the importance of a strong laboratory infrastructure. Objectives: This study details the informational challenges faced by the laboratory at Kamuzu Central Hospital, a tertiary health facility in Malawi; and proposes ways in which informatics can bolster the efficiency and role of low-resource laboratory systems. Methods: We evaluated previously-collected data on three different aspects of laboratory use. A four-week quality audit of laboratory test orders quantified challenges associated with collecting viable specimens for testing. Data on tests run by the laboratory over a one-year period described the magnitude of the demand for laboratory services. Descriptive information about the laboratory workflow identified informational process breakdowns in the pre-analytical and post-analytical phases and was paired with a 24-hour sample of laboratory data on results reporting. Results: The laboratory conducted 242 242 tests over a 12-month period. The four-week quality audit identified 54% of samples as untestable. Prohibitive paperwork errors were identified in 16% of samples. Laboratory service workflows indicated a potential process breakdown in sample transport and results reporting resulting from the lack of assignment of these tasks to any specific employee cadre. The study of result reporting time showed a mean of almost six hours, with significant variation. Conclusions: This analysis identified challenges in each phase of laboratory testing. Informatics could improve the management of this information by streamlining test ordering and the communication of test orders to the laboratory and results back to the ordering physician.