Martín AD, Díaz HDF, Nibot SC

Language: Spanish
References: 0
Page: 24-33
PDF size: 352.47 Kb.

ABSTRACT

Introduction: continuous validity of a diagnostic system depends on permanent follow-up of its performance and improvement of quality control elements.
Objective: evaluate the performance of the system ELISA DAVIH VIH-2 during its application in the period 2006-2012.
Methods: astudy was conducted of the specificity of the DAVIH BLOT VIH-1 system in a group of 4 960 individuals with indeterminate or negative HIV-1 results and 4 920 seropositive individuals. Attention was also paid to the accuracy of assays performed on DAVIH VIH-2 by variation coefficient estimation and development of Lewey-Jennings charts, and agreement of the system versus the Hexagon HIV rapid test with kappa index estimation.
Results: specificity was above 98 % in both groups. Accuracy was appropriate, since variation coefficients were below 15 %, and values were distributed within permissible limits in the control charts. Agreement analysis revealed a kappa index of 0.946 for a very good agreement classification versus the results obtained by the Hexagon HIV system. With the use of the DAVIH VIH-2 system, 12 new HIV-2 seropositive cases were identified in the study period, i.e. 60 % of the cases diagnosed in Cuba until the year 2012.
Conclusions: the study of these performance parameters as time goes by make it possible to corroborate the observations made about the diagnostic medium during the analytical validation stage, substantiating the use foreseen for the system and the permanence of the diagnostic medium in the Health Registry of the corresponding regulatory institution as of the year 2006. It also enables Cuba to have a serological system for HIV-2 screening applied to the HIV diagnostic algorithm since that year.