Assessment of Rapid Diagnostic Tests Algorithms in Transfusion Medicine Setting

Screening for transfusion-transmissible infections (TTI) is mandatory in any national blood transfusion program. However, it should be noted that there are no screening programs for TTI which has no limits, the exclusive safety, perceived as the formal absence of infectious risk would be difficult to reach [1]. Nevertheless, much effort has been put into developing strategies to reduce the risk of transmission of infectious agents through blood transfusion. There is a great deal of variability in screening strategies and in the choice of tests. In addition, the tests used have different sensitivities and specificities. The specificity increasing from immunochromatographic tests called rapid diagnostic tests (RDTs) to so-called molecular tests. As a result, screening strategies may differ from high-income countries to low-income countries and between different levels within the health system of the same country [2]. Despite the combination of sensitive RDTs and specific tests like ELISA, studies have shown that there is a residual risk of TTI [3] [4] [5]. This residual risk is even higher in low-income countries than in high-income countries. The molecular tests can detect viral DNA or RNA and are effective in detecting infected donors who are in a period of seroconversion [6]. However, the implementation of these tests in routine clinical laboratories encounters technical and financial difficulties due to the lack of qualified persons and the cost of equipment and infrastructure particularly in low-income countries and especially in the provinces [4]. The RDTs which are simple in use and do not need high qualified biologists, heavy equipment’s and infrastructures play a pivotal role and represent an alternative way for blood screening in low-income setting [7]. The analytical performance of RDTs are sometimes could be altered by poor storage, transport conditions over long distance and manufacturing defect upstream the clinical laboratory [8] [9]. The aim of this work is to assess the diagnostic value of HIV, HBV and HCV RDTs algorithms by using the ELISA as a reference test.