Evaluation of an Immunochromatographic Assay for the Detection of Rotavirus / 임상검사와정도관리

ABSTRACT

BACKGROUND: Rotaviruses are the primary cause of severe acute gastroenteritis in infants and young children worldwide. We evaluated the performance of the new GENEDIA Rotavirus Ag Rapid test (Greencross Medical Science, Korea) immunochromatographic assay (ICA) for detecting human rotavirus in stool specimens, in comparison with ELISA and PCR assays. METHODS: One hundred rotavirus-positive stool samples and 150 rotavirus-negative stool samples, confirmed by ELISA and PCR tests, were analysed using the GENEDIA Rotavirus Ag rapid test. The positive agreement (sensitivity), negative agreement (specificity), and total agreement rates of the ICA compared to ELISA and PCR were determined. To assess the analytical performance of the ICA, we tested its detection limit, reproducibility, and cross-reactivity. RESULTS: The positive, negative, and total agreement rates of the ICA were 99%, 100%, and 99.6%, respectively, when compared with the results confirmed by ELISA and PCR. The total turnaround time of the ICA was less than 20 minutes. The lower limit of detection of the ICA for rotavirus was 1.33x10(3) TCID50/mL, which was similar to that of ELISA but higher than that of PCR. No cross-reactivity was detected for 11 viruses and 19 bacteria. CONCLUSIONS: The GENEDIA Rotavirus Ag rapid test was easy to perform and provided rapid results, which showed high agreement with those obtained using ELISA and PCR. This test appears to be a useful tool for the diagnosis of rotavirus infection.