Key result
The SD BIOLINE Norovirus immunochromatographic assay demonstrated a sensitivity of 76.5% and specificity of 99.7% for detecting norovirus compared with real-time RT-PCR.
Why the study?
Does the SD BIOLINE Norovirus immunochromatographic assay kit accurately detect norovirus in fecal specimens compared to real-time RT-PCR?
Cross-Sectional (n=411)
Does the SD BIOLINE Norovirus immunochromatographic assay kit accurately detect norovirus in fecal specimens compared to real-time RT-PCR?
The SD BIOLINE Norovirus assay is highly specific but moderately sensitive, making it a useful rapid screening tool that may require PCR confirmation for negative results.
Supports rapid screening with high specificity but requires PCR confirmation of negatives; leaves open prospective validation in varied settings.
Rapid and accurate detection of norovirus is essential for the prevention and control of norovirus outbreaks. This study compared the effectiveness of a new immunochromatographic assay kit (SD BIOLINE Norovirus; Standard Diagnostics, Korea) and real-time reverse transcription-PCR (RT-PCR) for detecting norovirus in fecal specimens. Compared with real-time RT-PCR, the new assay had sensitivity, specificity, positive predictive value, and negative predictive value of 76.5% (52/68), 99.7% (342/343), 98.1% (52/53), and 95.5% (342/358), respectively. The sensitivity of the assay was 81.8% (18/22) for GII.3 and 75.7% (28/37) for GII.4. None of the 38 enteric virus-positive specimens (3 for astrovirus, 5 for enteric adenovirus, and 30 for rotavirus) tested positive in the cross-reactivity test performed by using this assay. The new immunochromatographic assay may be a useful screening tool for the rapid detection of norovirus in sporadic and outbreak cases; however, negative results may require confirmatory assays of greater sensitivity.
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Park et al. (2012) conducted a cross-sectional in Norovirus (n=411). SD BIOLINE Norovirus immunochromatographic assay kit vs. Real-time reverse transcription-PCR (RT-PCR) was evaluated on Sensitivity and specificity for detecting norovirus. The SD BIOLINE Norovirus immunochromatographic assay demonstrated a sensitivity of 76.5% and specificity of 99.7% for detecting norovirus compared with real-time RT-PCR.
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