Diagnostic Accuracy of Immunochromatographic Tests for the Detection of Norovirus in Stool Specimens: a Systematic Review and Meta-Analysis.

Yoon, Seo Hee; Kim, Hye Rim; Ahn, Jong Gyun

Noroviruses are the leading cause of acute gastroenteritis in all age groups and constitute a major health and economic burden worldwide. This systematic review and meta-analysis aimed to determine the diagnostic accuracy of immunochromatographic tests (ICTs) for the detection of norovirus in stool specimens, which has not been performed previously. In this systematic review and meta-analysis (registered on PROSPERO, CRD42020186911), we searched Medline/PubMed, Embase, Cochrane Library, and Web of Science for all studies published up to 16 May 2020. The values for sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), and diagnostic odds ratio (DOR) of ICTs with 95% confidence interval (CI) were pooled using a bivariate random-effects model. The summary receiver operating characteristic curve and area under the curve were used to summarize overall test accuracy. We included 43 studies describing 7,428 samples. The overall estimates of sensitivity, specificity, LR+, LR-, DOR, and accuracy of ICT for diagnosing norovirus were 0.61 (95% CI, 0.54 to 0.67), 0.97 (95% CI, 0.95 to 0.98), 17.08 (95% CI, 11.15 to 26.18), 0.40 (95% CI, 0.34 to 0.46), 53.9 (95% CI, 31.32 to 92.78), and 0.928, respectively. Significant differences in pooled sensitivities were noted between age groups and in pooled DOR and LR+ between genogroups of included samples. ICT provides low sensitivity but high specificity and accuracy for detecting norovirus. Thus, an ICT for norovirus can be a rapid and convenient way for identifying patients early; however, a negative result cannot rule out norovirus infection and should be confirmed by a reference test.