Assessment of Rapid Diagnostic Tests Algorithms in Transfusion Medicine Setting

Abstract

Background: The rapid diagnostic tests play a pivotal role in the screening of viral markers in blood qualification for transfusion in limited resource setting. Therefore, it is important to assess their analytical performances to ensure their proper functioning. Material and Methods: We performed a cross- sectional study by successive recruitment to assess the diagnostic value of rapid diagnostic tests algorithms using ELISA as a reference test. A total of 661 blood from donors were enrolled for this study. Rapid Diagnostic Tests (RDTs) and ELISA tests were performed for each sample by a couple of double-blinded biotechnologists. Data were collected on case report form and captured in Microsoft Excel then the file was imported and analyzed using R software version 4.0.3. Results: The diagnostic accuracy for the algorithms are summarized in Table 1. For HIV-algorithm, the internal validity parameters were as follow: sensitivity (sens) 99.0% (95% CI = 97.8, 99.5); specificity (spec) 98.3% (95% CI = 90.9, 99.7); positive likelihood ratio (PLR) 57.4 (95% CI = 8.2, 401.0); negative likelihood ratio (NLR) 0.01 (95% CI = 0.0005, 0.02); diagnostic odd ratio (DOR) 4710. HBV-Ag/Ab RDTs achieve the following diagnostic accuracy: sens 99.7% (95% CI = 98.3, 99.9); spec 98.8% (95% CI = 96.9, 95.5); PLR 81.8 (95% CI = 30.9, 217.0); NLR 0.003 (95% CI = 0.0004, 0.02); DOR 14,110. The analytical performances of HCV-Ab RDTs were as follow: sens 98.7% (95% CI = 97.5, 99.4); spec 93.1% (95% CI = 78.0, 98.1); PLR 14.3 (95% CI = 3.8, 54.5); NLR 1.5 (95% CI = 0.8, 2.8); DOR 962.6. The parameters evaluating the external validity of RDTs screening for the three viral markers when the theorical prevalence was 5% are summarized in Figure 3. At the prevalence , 99.99% and 99.94%. At the same prevalence, we found the following Positive Predictive Values (PPV) 70.82%, 77.59% and 37.35% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. The overall areas under the received operating characteristic (ROC) curves were 98.6%, 99.2% and 99.2%; 95.9% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. Conclusion: RDTs algorithms can play a pivotal role in the screening of HIV-Ab/Ag, HBs-Ag in the setting of resources limited-countries where financial and technical expertise shortages are a standard fare. However, their use for diagnostic purposes must be done with great caution and the result must necessarily be confirmed with an ELISA or molecular technique particularly for HCV-RDTs algorithm which achieved an NLR value > 0.1.