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Test ID LNORO Norovirus PCR, Molecular Detection, Feces

Useful For

Diagnosing gastrointestinal disease (diarrhea or vomiting) caused by norovirus genogroups 1 and 2

 

This test should not be used as a test-of-cure.

Method Name

Real-Time Polymerase Chain Reaction (PCR)/RNA Probe Hybridization

Reporting Name

Norovirus PCR, F

Specimen Type

Fecal


Shipping Instructions


Place vial in a sealed plastic bag and ship ambient. Specimens received at other temperatures will be rejected, and testing will be canceled.



Specimen Required


Supplies: Culture and Sensitivity Stool Transport Vial (T058)

Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of non-nutritive transport medium - either Cary-Blair, Para-Pak Culture and Sensitivity Media)

Specimen Volume: Representative portion of diarrheal fecal sample, 1 gram or 5 mL

Collection Instructions:

1. Collect fresh feces and place in preservative within 1 hour of collection.

2. Visibly formed feces are not consistent with Norovirus gastrointestinal disease and should not be submitted for testing.


Specimen Stability Information

Specimen Type Temperature Time Special Container
Fecal Ambient 7 days

Reject Due To

Nonpreserved feces
Transport media other than Cary-Blair or C and S
Modified Cary-Blair
Visibly formed feces
Reject

Clinical Information

Noroviruses, previously known as Norwalk-like viruses, are highly contagious RNA viruses that cause acute gastroenteritis (diarrhea, vomiting). Although 6 genogroups of norovirus have been identified, only 3 genogroups (genogroup: G1, G2, and G4) cause disease in humans. Furthermore, the majority of outbreaks have been associated with G1 and G2, with G2 being most common.(1)

 

Noroviruses are transmitted through close, personal contact with an infected individual or via the fecal-oral route in which the virus becomes ingested in contaminated food or water. These viruses are extremely contagious, with fewer than 20 virions being able to cause disease.(1)

 

Once infected, the incubation period is typically short, between 24 and 72 hours. The onset of symptoms is abrupt, with vomiting and watery nonbloody diarrhea being common. Patients may also experience a low-grade fever, as well as headache and mild body aches.(1)

 

The diagnosis of norovirus infection can often be made on clinical grounds, and symptoms generally resolve in 24 to 48 hours. However, in certain patients, especially those who are immunocompromised or hospitalized, laboratory testing may be indicated for infection control purposes and to limit the use of antibiotics. Testing of diarrheal feces by real-time polymerase chain reaction allows for a rapid and sensitive means of detecting and differentiating norovirus G1 and G2 in clinical stool samples.

Reference Values

Negative

Interpretation

A positive result indicates that RNA from norovirus genogroups 1 and/or 2 was present in the clinical specimen.

 

A negative result suggests that RNA from norovirus genogroups 1 and 2 was absent in the clinical specimen.

Cautions

A positive result suggests that norovirus is the cause of gastrointestinal disease (diarrhea or vomiting); however, in certain patients (eg, immunocompromised hosts), norovirus may be shed for weeks to months in the absence of symptoms.(2)

 

This test should not be used as a test-of-cure, due to the fact that norovirus nucleic acid may be detected in patients for weeks to months following the resolution of symptoms.(2)

 

A negative result suggests that norovirus is not the cause of gastrointestinal disease (diarrhea or vomiting); however, viral nucleic acid may be present at a level that is below the limit of detection for this test. The results should be interpreted in the context of the patient's clinical presentation and other laboratory findings.

Clinical Reference

1. National Center for Immunization and Respiratory Diseases, Division of Viral Diseases: Norovirus. Center for Disease Control and Prevention; 2013. Updated February 23, 2023. Accessed March 28, 2023. Available at www.cdc.gov/norovirus/index.html

2. Echenique IA, Stosor V, Gallon L, Kaufman D, Qi C, Zembower TR: Prolonged norovirus infection after pancreas transplantation: a case report and review of chronic norovirus. Transpl Infect Dis. 2016 Feb;18(1):98-104

Method Description

This assay utilizes real-time, TaqMan-based polymerase chain reaction (PCR) technology to target the nonstructural polyprotein gene of norovirus G1 and G2. Nucleic acid is extracted from diarrheal stool samples in Cary-Blair media. Following extraction of viral RNA, reverse transcription is performed to convert norovirus genomic RNA to complementary DNA. Real-time amplification and detection are then performed. Two separate real-time PCR reactions are performed for each sample, one specific for norovirus G1 and the second targeting norovirus G2. The assay is able to accurately detect and differentiate these genogroups in clinical stool samples.(Unpublished Mayo method)

Day(s) Performed

Monday through Sunday

Report Available

2 to 5 days

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87798 x 2

NY State Approved

Yes