Evaluation of a Highly Sensitive Norovirus Bioluminescent Enzyme Immunoassay BL-NV EIKEN for Stool Specimens

Abstract

BL-NV EIKEN, which is a novel norovirus detection kit based on bioluminescent enzyme immunoassay (BLEIA) was evaluated in a comparative study with a real time RT-PCR (rRT-PCR) for the 220 fecal specimens. As a result, the sensitivity was 94.1% (95/101), specificity was 98.3% (117/119) and concordance rate of the BLEIA was 96.4% (212/220), demonstrating that the BLEIA was equivalent to rRT-PCR with regard to the diagnostic accuracy. Furthermore, most of the 177 negative specimens were distributed from 0.2 COI (cutoff index) to 0.4 COI, indicating that the BLEIA has a satisfactory criterion which enables to distinguish positive and negative clearly. Since the BLEIA has high performance equivalent to rRT-PCR, a short turnaround time of 46 minutes, and a high throughput of 120 tests per hour, the assay is expected to be used in the screening for NV-infected food-handlers in the near future.