Evaluation of a commercial ELISA kit for the detection of anti-dengue IgM in serum of patients from a hospital in the north of Peru

Abstract

Background: capture-Igm (immunoglobulin) ELISA (enzyme-linked immunosorbent assay) is the main immunoenzymatic assay used in the diagnosis of dengue, for this purpose there are several commercial tests with different output.Objective: to evaluate the diagnostic usefulness of the Serion ELISA classic Dengue Virus IgM kit in serum of patients treated at the Lambayeque Regional Hospital, Peru, in 2016 and 2017.Methods: a cross-sectional analytical study was carried out with 114 serum samples, 57 positive and 57 negative, determined by the Tariki – Dengue IgM national test used as the reference test. Concordance analysis, determination of sensitivity, specificity and optimum cut-off point for the ROC curve were analyzed by means of EPIDATA statistical package and XLSTAT program.Results: Concordance between the Serion ELISA classic Dengue Virus IgM commercial kit and the national reference kit was good, Kappa (κ) index of 0,63. The commercial kit presented high sensitivity (100 %) and low specificity (63,16). The optimum cut-off point was determined, adjusted to our population in 40,7 U/mL, with the highest joint sensitivity and specificity, 95 % (IC 95 % 85 – 99) and 90 % (IC 95 % 78 – 95), respectively. The results were classified in 54 true positive, 51 true negative, always compared with the reference kit.Conclusions: The commercial Serion ELISA classic Dengue Virus IgM kit shows good concordance and high sensitivity in detecting dengue cases for the study population, considering 40,7 U/ml as the cut-off point.

Keywords

• dengue
• immunoglobulin m
• reagent kits
• diagnostic
• peru
• sensitivity and specificity
• roc curve