Available online 15 October 2023, 105612

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Diagnosis of gastrointestinal infections has been revolutionized by the development of in vitro diagnostic (IVD) multiplex molecular panels for the detection of viral nucleic acids. In addition to a high degree of accuracy, these panels are commercially available and relatively simple to perform in the clinical laboratory. However, use of these panels must be carefully considered owing to the laboratory costs of the test, limited reimbursement, and potential for overuse. In this review from the Pan American Society for Clinical Virology, we focus on the viral components of GI multiplex panels (GIPs), presenting a brief overview of pathogens included on most panels, and a discussion of advantages and challenges of the inclusion of viral targets on GIPs that should be considered before implementation in the clinical laboratory.

Section snippetsBackground

Laboratories implementing a gastrointestinal multiplex panel (GIP) have many options, with several more panels in development. Choosing the best panel for a laboratory requires consideration of many factors, including which targets are included and how many targets are on the panel. A previous publication from the Pan-American Society of Clinical Virology reviews the available panels and considerations for implementation [1]. In this review, we focus on the viral causes of gastroenteritis and

Review of viruses included on GIPs

Norovirus is a single-stranded positive sense non-enveloped RNA virus belonging to the family Caliciviridae. It is estimated that 658 million cases occur yearly, with 200 million cases in children <5 years of age [3]. Norovirus infections are typically characterized by sudden onset of nausea, vomiting, and diarrhea lasting 1 - 3 days. Severe disease may occur in individuals with underlying medical comorbidities, immunosuppression, or extremes of age. Asymptomatic infections may occur, and

Epidemiology and Public Health

Inclusion of viral targets in multiplex GIPs is valuable from a public health standpoint, allowing for identification and tracking of specific viral pathogens and the ability to differentiate between bacterial and/or parasitic etiologies. Use of broad multiplex panels have already elicited significant data on the rate of cases associated with co-infections, the seasonality of infections, and relative rates of disease attributable to viral pathogens [22,23]. GIPs have also been used to quickly

Cost of Testing and Reimbursement

GIPs are more expensive to run than other common diagnostic methods for gastroenteritis and are billed at a higher rate. This higher cost coupled with the fact that these panels are not appropriate in many clinical scenarios means that coverage by insurance (both private and government) is conditional. There are three common CPT codes used for billing: CPT code 87505 (gastrointestinal pathogen, 3-5 targets); CPT code 87506 (6-11 targets); and CPT code 87507 (12-25 targets) (CPT® (Current

Potential Solutions

Although the technology allows for the inclusion of numerous pathogen targets from a single reaction, the high cost of testing, limited insurance coverage, and medical necessity warrants a more thoughtful approach. Cost notwithstanding, the epidemiological and public health benefits, improved speed of diagnosis, superior diagnostic accuracy, and benefit for immunocompromised patients would support routine use of large GIPs in the appropriate clinical and epidemiological scenarios. However,

Uncited References

[6,7,39]

Disclosures/Disclaimers

This Report is a product of the PASCV Clinical Practice Committee (CPC) developed to provide guidance and recommendations to healthcare professionals considering implementation of multiplex molecular tests. It is not clinical advice and does not represent all possible facets of panel utility.

Declaration of Competing Interest

D. Jane Hata and Eleanor Powell report no financial conflicts of interest. M. Starolis is a full-time employee and stockholder at Quest Diagnostics and has served as an unpaid advisor to Roche and BioRad. D. Jane Hata, Eleanor Powell, and M. Starolis are all members of the Pan American Society for Clinical Virology Clinical Practice and Public Policy Committee.

Acknowledgment

The authors thank the members of the PASCV Clinical Practice and Public Policy Committee for thoughtful critique and review of this document. The authors thank Dawn Zenefski and Michelle Yovanovic for review of sections related to insurance coverage and reimbursement.

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