Research Article
Otto Cruz Sui, Dervel Felipe D
Abstract
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.