ABSTRACT
BACKGROUND: Following a 1994 study showing a high rate of transfusion-associated HIV, Kenya implemented WHO blood safety recommendations including: organizing the Kenya National Blood Transfusion Service (NBTS), stringent blood donor selection, and universal screening with fourth-generation p24 antigen and HIV antibody assays. Here, we estimate the risk of transfusion-associated HIV transmission in Kenya resulting from NBTS laboratory error and consider the potential safety benefit of instituting pooled nucleic acid testing (NAT) to reduce window period transmission. METHODS: From November to December 2008 in one NBTS regional centre, and from March to June 2009 in all six NBTS regional centres, every third unit of blood screened negative for HIV by the national algorithm was selected. Dried blood spots were prepared and sent to a reference laboratory for further testing, including NAT. Test results from the reference laboratory and NBTS were compared. Risk of transfusion-associated HIV transmission owing to laboratory error and the estimated yield of implementing NAT were calculated. FINDINGS: No cases of laboratory error were detected in 12,435 units tested. We estimate that during the study period, the percentage of units reactive for HIV by NAT but non-reactive by the national algorithm was 0·0% (95% exact binomial confidence interval, 0·00-0·024%). INTERPRETATION: By adopting WHO blood safety strategies for resource-limited settings, Kenya has substantially reduced the risk of transfusion-associated HIV infection. As the national testing and donor selection algorithm is effective, implementing NAT is unlikely to add a significant safety benefit. These findings should encourage other countries in the region to fully adopt the WHO strategies.