High transmission risk of Human Immunodeficiency Virus in blood transfusions: A critical evaluation of blood bank serological tests in Mozambique

Many settings in sub-Saharan Africa use rapid antibody assays to detect human immunodeficiency virus (HIV) infection among blood donor candidates. This study aimed to evaluate the analytical performance of HIV serological tests used to screen blood donor candidates in Mozambique. Determine HIV 1/2 + Uni-Gold HIV (the routine HIV testing at blood banks in Mozambique), and two newer rapid tests (Determine HIV Early Detect and Meriscreen HIV1–2 Western Blot) were compared with an Enzyme-Linked Immunosorbent Assays (Merilisa HIV Gen 4 test + Uni-Gold HIV). Additionally, all serological tests were compared with the molecular cobas MPX test. The sensitivity and specificity of Determine HIV 1/2 + Uni-Gold HIV; Determine HIV Early Detect, and Meriscreen HIV1–2 Western Blot compared to the Merilisa HIV Gen 4 test + Uni-Gold were 85.5% and 99.6%; 88.7% and 99.5%; 90.0% and 99.6% respectively. The sensitivity and specificity of Determine HIV 1/2 + Uni-Gold HIV; Determine HIV Early Detect, Meriscreen HIV1–2 Western Blot, and Merilisa HIV Gen 4 test + Uni-Gold compared to the cobas MPX test were 64.0% and 99.1%; 68.6% and 99.1%; 70.8% and 99.0%; 66.0% and 99.4%, respectively. The probability of undetected positive results in the rapid tests and Merilisa HIV Gen 4 test ranged from 5.6 to 6.7 per 1,000 blood donors. The results of this study point to the need for the introduction of molecular testing for HIV in blood banks in developing countries to improve transfusion safety and contribute to controlling HIV as a public health problem.