N Kanwar1, F Hassan1, L Barclay2, C Langley2, J Vinjé2, P W Bryant3, K St George3, L Mosher4, J M Matthews-Greer4, M A Rocha5, D O Beenhouwer6, C J Harrison7, M Moffatt7, N Shastri7, R Selvarangan8. 1. Department of Pathology and Laboratory Medicine, Children's Mercy Hospital and Clinics, Kansas City, MO, USA. 2. Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA. 3. Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, NY, USA. 4. Michigan Department of Human and Health Services, MI, USA. 5. Division of Infectious Diseases, VA Greater Los Angeles Healthcare System, CA, USA. 6. Division of Infectious Diseases, VA Greater Los Angeles Healthcare System, CA, USA; Department of Medicine, University of California Los Angeles, CA, USA. 7. Department of Pathology and Laboratory Medicine, Children's Mercy Hospital and Clinics, Kansas City, MO, USA; Department of Pediatrics, University of Missouri-Kansas City School of Medicine, Kansas City, MO 64108, USA. 8. Department of Pathology and Laboratory Medicine, Children's Mercy Hospital and Clinics, Kansas City, MO, USA; Department of Pediatrics, University of Missouri-Kansas City School of Medicine, Kansas City, MO 64108, USA. Electronic address: rselvarangan@cmh.edu.
Abstract
BACKGROUND: Norovirus is the leading cause of epidemic and sporadic acute gastroenteritis (AGE) in the United States. Widespread prevalence necessitates implementation of accurate norovirus detection assays in clinical diagnostic laboratories. OBJECTIVE: To evaluate RIDA®GENE norovirus GI/GII real-time RT-PCR assay (RGN RT-PCR) using stool samples from patients with sporadic AGE. STUDY DESIGN: Patients between 14 days to 101 years of age with symptoms of AGE were enrolled prospectively at four sites across the United States during 2014-2015. Stool specimens were screened for the presence of norovirus RNA by the RGN RT-PCR assay. Results were compared with a reference method that included conventional RT-PCR and sequencing of a partial region of the 5'end of the norovirus ORF2 gene. RESULTS: A total of 259 (36.0%) of 719 specimens tested positive for norovirus by the reference method. The RGN RT-PCR assay detected norovirus in 244 (94%) of these 259 norovirus positive specimens. The sensitivity and specificity (95% confidence interval) of the RGN RT-PCR assay for detecting norovirus genogroup (G) I was 82.8% (63.5-93.5) and 99.1% (98.0-99.6) and for GII was 94.8% (90.8-97.2) and 98.6% (96.9-99.4), respectively. Seven specimens tested positive by the RGN-RT PCR that were negative by the reference method. The fifteen false negative samples were typed as GII.4 Sydney, GII.13, GI.3, GI.5, GI.2, GII.1, and GII.3 in the reference method. CONCLUSIONS: The RGN RT-PCR assay had a high sensitivity and specificity for the detection of norovirus in stool specimens from patients with sporadic AGE.
BACKGROUND: Norovirus is the leading cause of epidemic and sporadic acute gastroenteritis (AGE) in the United States. Widespread prevalence necessitates implementation of accurate norovirus detection assays in clinical diagnostic laboratories. OBJECTIVE: To evaluate RIDA®GENE norovirus GI/GII real-time RT-PCR assay (RGN RT-PCR) using stool samples from patients with sporadic AGE. STUDY DESIGN: Patients between 14 days to 101 years of age with symptoms of AGE were enrolled prospectively at four sites across the United States during 2014-2015. Stool specimens were screened for the presence of norovirus RNA by the RGN RT-PCR assay. Results were compared with a reference method that included conventional RT-PCR and sequencing of a partial region of the 5'end of the norovirus ORF2 gene. RESULTS: A total of 259 (36.0%) of 719 specimens tested positive for norovirus by the reference method. The RGN RT-PCR assay detected norovirus in 244 (94%) of these 259 norovirus positive specimens. The sensitivity and specificity (95% confidence interval) of the RGN RT-PCR assay for detecting norovirus genogroup (G) I was 82.8% (63.5-93.5) and 99.1% (98.0-99.6) and for GII was 94.8% (90.8-97.2) and 98.6% (96.9-99.4), respectively. Seven specimens tested positive by the RGN-RT PCR that were negative by the reference method. The fifteen false negative samples were typed as GII.4 Sydney, GII.13, GI.3, GI.5, GI.2, GII.1, and GII.3 in the reference method. CONCLUSIONS: The RGN RT-PCR assay had a high sensitivity and specificity for the detection of norovirus in stool specimens from patients with sporadic AGE.
Authors: Richard S P Huang; Coreen L Johnson; Lauryn Pritchard; Richard Hepler; Trang T Ton; James J Dunn Journal: Diagn Microbiol Infect Dis Date: 2016-09-22 Impact factor: 2.803
Authors: Mark D Gonzalez; L Claire Langley; Blake W Buchan; Matthew L Faron; Melanie Maier; Kate Templeton; Kimberly Walker; Elena B Popowitch; Melissa B Miller; Arundhati Rao; Uwe G Liebert; Nathan A Ledeboer; Jan Vinjé; C A Burnham Journal: J Clin Microbiol Date: 2015-11-11 Impact factor: 5.948
Authors: Daniel C Payne; Jan Vinjé; Peter G Szilagyi; Kathryn M Edwards; Mary Allen Staat; Geoffrey A Weinberg; Caroline B Hall; James Chappell; David I Bernstein; Aaron T Curns; Mary Wikswo; S Hannah Shirley; Aron J Hall; Benjamin Lopman; Umesh D Parashar Journal: N Engl J Med Date: 2013-03-21 Impact factor: 91.245
Authors: Christopher J Harrison; Ferdaus Hassan; Brian Lee; Julie Boom; Leila C Sahni; Coreen Johnson; James Dunn; Daniel C Payne; Mary E Wikswo; Umesh Parashar; Rangaraj Selvarangan Journal: Open Forum Infect Dis Date: 2021-11-24 Impact factor: 3.835
Authors: Divya Samantha Kondapi; Sasirekha Ramani; Mary K Estes; Robert L Atmar; Pablo C Okhuysen Journal: Open Forum Infect Dis Date: 2021-03-14 Impact factor: 3.835