Faculty Collaboration Database

Multicenter Evaluation of the Xpert Norovirus Assay for Detection of Norovirus Genogroups I and II in Fecal Specimens. J Clin Microbiol 2016 Jan;54(1):142-7

Date

11/13/2015

Pubmed ID

26560532

Pubmed Central ID

PMC4702714

DOI

10.1128/JCM.02361-15

Scopus ID

2-s2.0-84954319782 (requires institutional sign-in at Scopus site)   33 Citations

Abstract

Norovirus is the most common cause of sporadic gastroenteritis and outbreaks worldwide. The rapid identification of norovirus has important implications for infection prevention measures and may reduce the need for additional diagnostic testing. The Xpert Norovirus assay recently received FDA clearance for the detection and differentiation of norovirus genogroups I and II (GI and GII), which account for the vast majority of infections. In this study, we evaluated the performance of the Xpert Norovirus assay with both fresh, prospectively collected (n = 914) and frozen, archived (n = 489) fecal specimens. A Centers for Disease Control and Prevention (CDC) composite reference method was used as the gold standard for comparison. For both prospective and frozen specimens, the Xpert Norovirus assay showed positive percent agreement (PPA) and negative percent agreement (NPA) values of 98.3% and 98.1% for GI and of 99.4% and 98.2% for GII, respectively. Norovirus prevalence in the prospective specimens (collected from March to May of 2014) was 9.9% (n = 90), with the majority of positives caused by genogroup II (82%, n = 74). The positive predictive value (PPV) of the Xpert Norovirus assay was 75% for GI-positive specimens, whereas it was 86.5% for GII-positive specimens. The negative predictive values (NPV) for GI and GII were 100% and 99.9%, respectively.

Author List

Gonzalez MD, Langley LC, Buchan BW, Faron ML, Maier M, Templeton K, Walker K, Popowitch EB, Miller MB, Rao A, Liebert UG, Ledeboer NA, Vinjé J, Burnham CA

Authors

Blake W. Buchan PhD Professor in the Pathology department at Medical College of Wisconsin
Nathan A. Ledeboer PhD Vice Chair, Professor in the Pathology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Aged
Aged, 80 and over
Caliciviridae Infections
Child
Child, Preschool
Feces
Female
Genotype
Humans
Infant
Infant, Newborn
Male
Middle Aged
Molecular Diagnostic Techniques
Norovirus
Predictive Value of Tests
Prospective Studies
Virology
Young Adult