Validation of the commercial enzyme immunoassay techinique for rotavirus diagnosis in order to promoteclinical aimed studies in Brazil

Abstract

Group A rotaviruses (RV-A) cause diarrheic disease that occur especially in children under 5 years old. Annually, 130 million diarrhea cases by RV-A are estimated, with 453,000 deaths and 2 million cases of hospitalizations. The immunoenzymatic assay presents a high sensibility and convenience, and it has been widely used in lab routine work in the RV-A detection. This study aimed to evaluate the development of RIDASCREEN^® Rotavirus in relation to the Premier™ Rotaclone^® Rotavirus reference test, analyzing specificity, sensitivity, accuracy, interference, reproducibility and stability of that assay. Forty fecal samples were used, collected from May 2008 to May 2009 of the children's health centers in Belém, Pará State, Brazil with tests that were conducted at the Virology Section of the Instituto Evandro Chagas. The results showed 90% (36/40) of matching between those two methodologies, with sensibility of 90% (27/30) and specificity of 100% (10/10). There was no change on accuracy, interference, reproducibility and stability of RIDASCREEN^® test in relation to Rotaclone^®. The results obtained by this study indicated that RIDASCREEN^® has similar development comparing to the gold standard test, so it can be used in the lab routine work.