Assessment of a rapid immunochromatographic test for the diagnosis of norovirus gastroenteritis

Abstract

Noroviruses are the leading cause of acute gastroenteritis in people of all ages. Since the viruses are highly infectious, rapid and early diagnosis is important to prevent and control the disease. The present study aimed to evaluate the commercial immunochromatographic test RIDA® QUICK Norovirus for the detection of norovirus in stool samples from patients with acute gastroenteritis in Thailand. As compared with reference RT-PCR results, the RIDA® QUICK Norovirus assay provided a sensitivity of 48.2 and 83.3% with a specificity of 87.5%. False positive results were observed in 12.5% of norovirus-negative stool samples. Based on commercial quantitative real-time RT-PCR, the RIDA® QUICK Norovirus assay revealed a highly significant association, p-value <0.001, and good agreement (kappa = 0.6). The assay could detect norovirus in stool samples ranging from 3.22 × 10(6) to 3.26 × 10(8) copies/ml. False negative results occurred in the stool samples containing 5.9 × 10(6) copies/ml of norovirus GI or 1.85 × 10(4) - 4.28 × 10(5) copies/ml of GII. The immunochromatographic RIDA® QUICK Norovirus assay may be useful for rapid screening of norovirus infections in patients with acute gastroenteritis in both developed and developing countries where the RT-PCR method has not been established for routine diagnosis.