Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

Abstract

Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose. Methodology: Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1 st to June the 30 th , 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni-Gold HIV, and DoubleCheckGold Ultra HIV 1&2 compared to the laboratorybased 4 th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen's Kappa Statistic, κ. Results: Of 312 participants who donated blood, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1 years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV-1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and 100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1&2. Cohen's Kappa Statistic showed moderate agreement between the 4 th generation ELISA apDia HIV Ag/Ab and either Alere Determine HIV-1/2 and Uni-Gold HIV (κ = 0.66; 95% CI: 0.55-0.76) but good agreement for DoubleCheckGold Ultra HIV1&2 (κ = 0.72; 95% CI: 0.61 -0.82). Conclusions: Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3 rd generation HIV RDTs showed poor field accuracy results for blood donor screening. These data support the need for 4 th generation Ag-Ab RDTs in transfusion blood qualification.

A Comparative Analysis of the different HIV Testing Techniques used in Zambia: Data from a Clinical Performance Study

“…21 The study is consistent with the ndings by Kashosi who found that when compared to the laboratorybased ELISA HIV Ag/Ab assay, the currently used 3rd generation HIV RDTs showed poor eld accuracy. 17 According to their Manufacturers, RDTs have high sensitivity and speci city for licensing purposes and subsequent World Health Organization (WHO) prequali cation. 18 Despite this, HIV RDTs have some limitations since they cannot identify persons who are within the window period of an acute HIV infection because these individuals have not yet developed HIV-speci c antibodies.…”

“…25,26 This study highlights the important issue of possible false-negative HIV test results, which in part may be explained by the failure of these RDTs to diagnose HIV during the window. 17 During this period, HIV infection can be detected only by tests detecting also viral antigen such as the laboratory-based 4th generation ELISA. 22 The baseline HIV prevalence in the population in uences the negative and PPV and needs to be considered in the interpretation of HIV RDT results.…”

“…26,27 According to Kashosi it seemed unlikely that the false-negative samples missed by HIV RDTs in the study, but which were positive for p24 antigen and/or HIV antibodies by the 4th generation ELISA, might represent very early infections (p24 antigen only) or somewhat later ones with antibodies at a low level, not detectable by the RDTs. 17 Given the qualitative results generated by the laboratory-based 4th generation ELISA test used and the lack of resources for p24 antigen or nucleic acid testing (NAT) in Eastern DRC, Kashosi could not resolve this uncertainty. 17 Other possible causes that may have caused false-negative results in this study include divergent HIV sub-types, human error-such as the addition of insu cient specimen or too much buffer when procedures are handled by non-trained or unsupervised staff.…”

“…17 Given the qualitative results generated by the laboratory-based 4th generation ELISA test used and the lack of resources for p24 antigen or nucleic acid testing (NAT) in Eastern DRC, Kashosi could not resolve this uncertainty. 17 Other possible causes that may have caused false-negative results in this study include divergent HIV sub-types, human error-such as the addition of insu cient specimen or too much buffer when procedures are handled by non-trained or unsupervised staff. 28 transportation or storage of test kits outside of recommended conditions, leading to possible denaturation of reagents or test devices, and the use of expired reagents or test devices.…”

“…Negative predictive values (at 95% CIs) were 99.1, 99.2 and 99.1 for OraQuick ADVANCE® Rapid HIV-1/2, Alere Determine HIV-1/2, and Uni-Gold Ultra HIV respectively similar to Kashoshi study ndings. 17 The results shown in…”