Otto Cruz Sui, Dervel Felipe DÃÂÂaz Herrera, Lucy Montano Tamayo, Kenia Romero MartÃÂÂnez, MarÃÂÂa Teresa Pérez Guevara and Eladio Silva Cabrera
Validation of performance characteristics of HIV diagnostic tests is one of the main demands of regulatory bodies. Evaluating of diagnostics tests prior to use avoid errors with a high economic and social cost. The aim of the work was to validate the DAVIH-BLOT modified system for simultaneous diagnosis of HIV-1/2. An evaluation with 166 samples of reference panels and a comparative study against a commercial kit of similar characteristics with an international reference panel of 25 samples was made. The new system expanded its diagnostic capacity with the incorporation of a gp36 synthetic peptide-protein conjugate, obtaining high results of sensitivity and specificity in the performance evaluation (99.18 and 76.74% respectively). In the comparative study with the analogue system the concordance was very good (kappa=1). The inclusion of the synthetic peptide and natural proteins in the same solid phase, constitute a technological novelty to this assay. The application of this test, allows a short cut of the diagnostic algorithm when are used screening tests for HIV-1 and 2 as in the Cuba’s diagnostic algorithm.
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