2015, Number 2
External quality assessment in the decentralization of HIV diagnosis in Cuba
Hernández AM, Silva CE, Pérez GMT, Romero MK, Sánchez DE
Language: Spanish
References: 10
Page: 165-172
PDF size: 126.52 Kb.
ABSTRACT
Introduction: A new algorithm strategy for the serological diagnosis of human immunodeficiency virus (HIV) infection was implemented in the year 2013. The first stage in the process of confirmatory diagnosis was decentralized and greater leadership was awarded to Provincial Hygiene, Epidemiology and Microbiology Centers (CPHEM).Objective: Evaluate the performance of CPHEMs within the External Quality Assessment Program (EQAP) in the period 2012-2013.
Methods: Five rounds of serum panels were analyzed. These consisted of seven samples with different serological profiles which had been previously characterized. Evaluation was based on quality rate estimation. Correspondence between expected and obtained results was also estimated. Accuracy was determined by estimating the variation coefficient in the results of 20 assayed replications of the same sample in the same run (intralaboratory) and in different runs (interlaboratory).
Results: All laboratories participated in the EQAP, except for four which did not reply to several submissions, affecting the participation percentage. Qualitatively, the performance of participating laboratories was excellent. However, variations were detected during accuracy determination. Laboratories C and G had scant participation, and in both cases the results submitted were above the maximum permissible value.
Conclusions: It was found that not all laboratories prioritize the EQAP, despite its being a compulsory requirement in Regulation 3-2009. It was observed that an excellent qualitative result may mask variations alerting to possible systematic errors, which could be solved preventively with a view to obtaining reliable results at this stage of decentralization of confirmatory HIV diagnosis in Cuba.
REFERENCES