Abstract
ABSTRACTNoroviruses 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.
Highlights
In meta-regression analysis, the population’s age and type of specimen were a significant source of heterogeneity (P, 0.05) (Table S2). To our knowledge, this is the first systematic review with meta-analysis evaluating the diagnostic performance of immunochromatographic tests (ICTs) for norovirus infection
Our review demonstrates that ICT possesses low sensitivity (0.609) but high specificity (0.967) and diagnostic accuracy (0.928) for the detection of norovirus in stool specimens
With a positive ICT result in a patient with symptoms, physicians can diagnose norovirus infection with conviction and can initiate appropriate infection control management
Summary
Regarding the risk of bias in patient selection, 62.8% of the studies had a “high” risk of bias because most studies did not clarify how they enrolled patients, whether consecutively or randomly; a diagnostic case-control design (e.g., norovirus infection status was already revealed using the reference standard, and samples were subsequently selected before the index test was performed) was used [52]. Most studies (90.7%) had an “unclear” risk of bias in the index test domain, since the blinding
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