TITLE:
Assessment of Rapid Diagnostic Tests Algorithms in Transfusion Medicine Setting
AUTHORS:
Modibo Coulibaly, Bakary Maiga, Dramane Samaké, Moussa Diawara, Mahamadou Traoré, Valentin Sagara, Bréhima Traoré, Oumar Guindo, Amagana Dolo
KEYWORDS:
Rapid Diagnostic Tests, Analytical Performances, Assessment, Transfusion Medicine
JOURNAL NAME:
Advances in Biological Chemistry,
Vol.11 No.1,
February
25,
2021
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.