Colloidal Gold Assay, a New Screening Test for Detection of RSV Infection: A Controlled Trial

Abstract

Background: Respiratory syncytial virus (RVS) is the main cause of morbidity and mortality in the pediatric population. Objectives: The objective of the study was to compare the diagnostic accuracies of the colloidal-gold-Genesis and newly developed real-time RT-PCR-IngeniGen with an admitted real-time RT-PCR-HuaRuiAn as the gold standard for respiratory syncytial virus detection. Methods: These three assays were performed on collected specimens. Results: Altogether 258 specimens were studied. Among them, real-time RT-PCR-HuaRuiAn detected the respiratory syncytial virus in 166 samples, while colloidal-gold-Genesis detected 171 samples and real-time RT-PCR-IngeniGen detected 168 samples as positive. The overall sensitivity for the detection of the respiratory syncytial virus in comparison to real-time RT-PCR-HuaRuiAn was 95.2% for colloidal-gold-Genesis and 100% for real-time RT-PCR-IngeniGen. The specificity was 85.9% for colloidal-gold-Genesis and 97.8% for real-time RT-PCR-IngeniGen. The positive likelihood ratio was 6.75 for colloidal-gold-Genesis and 45.45 for real-time RT-PCR-IngeniGen. The negative likelihood ratio was 0.06 for colloidal-gold-Genesis and 0.00 for real-time RT-PCR-IngeniGen. The cycle threshold value of real-time RT-PCR-IngeniGen was higher than that of real-time RT-PCR-HuaRuiAn. Conclusions: Colloidal-gold-Genesis is a good alternative for fast screening of respiratory syncytial virus detection.