Compromise in Rapid Test Kit Makes It Unsuitable for Blood Transfusion Safety

Abstract

In developing nations, blood safety continues to be a major dilemma due to high prevalence of infectious agents among blood donors compounded with the problem of limited resources that preclude the use of sensitive and specific technologies for screening of blood and blood products. The aim of this study was to compare the performances of rapid diagnostic kits to stringent enzyme-linked immunosorbent assays (ELISA) in the detection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) among prospective blood donors in Osun State, Southwest Nigeria. A total of 321 prospective blood donors from 3 senatorial districts in Osun State were recruited for the study after obtaining ethical clearance from LAUTECH Teaching Hospital Ethics Review Committee. Oral informed consent was obtained from each participant. The modified National Blood Transfusion Services (NBTS) questionnaire was administered to every participant to obtain information on exposure to risky behaviors, among others. Venous blood was collected and used for blood typing and viral screenings. Screening for HBsAg, HCV and HIV was done using rapid test kits (RTK) and ELISA. Data obtained were subjected to statistical analysisusing SPSS version 20.0 to generate frequency and central tendencies while Pearson’s Chi square was used for comparison of variables. Sensitivity, specificity, efficiency, positive predictive value and negative predictive value of the rapid test kits were obtained against ELISA. Prevalence of HBsAg, HCV and HIV by RTK were 8.65%, 0.64% and 1.6% respectively; while ELISA revealed prevalence of 8.97%, 0.64% and 2.24% for HBsAg, HCV and HIV respectively. The results obtained by RTK showed a compromised sensitivity, efficiency and negative predictive value. Gender and exposure to risky behaviours have no effect on the prevalence of all the Transfusion Transmissible Infections (TTIs) in the population studied. HBsAg rapid test kit revealed 100% specificity with sensitivity of 96.55% and HCV rapid kits had the same efficiency with third generation ELISA kit. With respect to HIV, the sensitivity of RTK was 77.78%, when validated against forth generation ELISA kit. It could be concluded from this study that the prevalence of TTI’s as determined by ELISA is higher, when compared to results generated by RTK method. Thus, there is residual risk of transmitting HBV and HIV to blood recipients, if blood units are screened using RTK only. Stringent ELISA procedures will bring the risk to the best achievable minimum when combined with administration of standard donor’s questionnaire.