Human noroviruses are the most common cause of acute gastroenteritis worldwide and cause substantial levels of morbidity and mortality. Symptoms usually include acute onset of vomiting, abdominal cramps and diarrhoea. Noroviruses are often associated with high-profile outbreaks in hospitals, nursing homes, cruise ships and the military which cause significant economical burden. Noroviruses are also considered to be the most common viral agents of epidemic food-borne and water-borne viral gastroenteritis. Globally noroviruses are the cause of 18 % of all diarrhoeal diseases.

Due to the extreme infectivity of noroviruses, rapid and reliable laboratory diagnosis is critical to guide the control of norovirus outbreaks by choosing the most appropriate intervention and control practices.

GenomEra® Norovirus assay is rapid and easy to use qualitative in vitro diagnostic (IVD) nucleic acid test for the detection and differentiation of norovirus genogroups I and II from raw or unpreserved unformed stool specimens or Copan eSwab preserved stool specimens. The assay requires less than one minute of hands-on-time per sample and results can be obtained in 70 minutes.

Clinical performance from three evaluation sites combined (n 277):
Positive percent agreement: 96 % (95 % CI: 90,1 % – 98,9 %)
Negative percent agreement: 99,4 % (95 % CI: 96,9 % – 99,99 %)

Assay procedure:

1. Pick the stool sample using flocked swab. Place and break the swab into eSwab tube and vortex.
2. Reconstitute the dried sample processing control by squeezing all contents of the vial into the sample tube. 3. Pick one loopful of the eSwab sample and mix it into the sample tube. 4. Heat the sample at 90 °C for 5 minutes to release the viral RNA, Vortex vigorously for 10 seconds. 5. Ensure that the samples have cooled down for 2 minutes after the heating step. Pipette 35 µl of the sample per chip and start the assay.