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Multiplex PCR and Reverse Line Blot Hybridization Assay mPCR/RLB
Published on: August 6, 2011
Point-Counterpoint: Large Multiplex PCR Panels Should Be First-Line Tests for Detection of Respiratory and Intestinal
Paul C Schreckenberger1, Alexander J McAdam2
1Loyola University Medical Center, Maywood, Illinois, USA pschrecken@lumc.edu alexander.mcadam@childrens.harvard.edu.
Abstract:
The first FDA-approved multiplex PCR panel for a large number of respiratory pathogens was introduced in 2008. Since then, other PCR panels for detection of several respiratory and gastrointestinal pathogens have been approved by the FDA and are commercially available, and more such panels are likely to become available. These assays detect 12 to 20 pathogens, and some include pathogens that typically cause different manifestations of infection, although they infect the same organ system. Some of these tests are labor-intensive, while others require little labor, and all of them are expensive, both for the laboratory and for the patient or insurer. They include a bundle of tests with limited or no options for selecting which tests will be performed. Laboratories and hospitals have adopted different strategies for offering these assays. Some have implemented strategies to limit the use of the tests, such as limiting the frequency with which patients can be tested, restricting testing to specific groups of patients (e.g., immunocompromised patients), or providing education to encourage the use of less expensive tests before using large multiplex panels. Others have offered these assays without limiting their use, either relying on the ordering provider to exercise good judgment or because such assays are thought to be appropriate for first-line diagnostic testing. In this Point-Counterpoint, Paul Schreckenberger of Loyola University Medical Center explains why his laboratory offers these assays without restriction. Alex McAdam of Boston's Children Hospital explains the concerns about the use of these assays as first-line tests and why some limitations on their use might be appropriate.
Insights
Multiplex PCR panels for respiratory and gastrointestinal pathogens offer broad detection but are costly. Strategies vary on limiting their use, with differing views on whether they are appropriate for first-line diagnostic testing.
Area of Science:
- Clinical Microbiology
- Infectious Diseases
- Molecular Diagnostics
Background:
- Multiplex PCR panels for detecting numerous respiratory and gastrointestinal pathogens have been FDA-approved since 2008.
- These commercially available assays can identify 12-20 pathogens, sometimes including those causing varied symptoms within the same organ system.
- The tests are expensive, labor-intensive to varying degrees, and often bundled without selective testing options.
Purpose of the Study:
- To explore differing institutional strategies for offering multiplex PCR panels.
- To present arguments for and against unrestricted use of these broad diagnostic panels.
- To discuss the appropriateness of multiplex PCR panels as first-line diagnostic tests.
Main Methods:
- This is a Point-Counterpoint discussion analyzing current practices and expert opinions.
- No new experimental data was generated; the focus is on contrasting viewpoints.
- The discussion reviews laboratory adoption strategies and clinical utility considerations.
Main Results:
- Laboratories have adopted varied strategies, including limiting test frequency, restricting patient groups, or promoting less expensive alternatives before panel use.
- Some institutions offer panels without restrictions, trusting provider judgment or considering them suitable for initial diagnosis.
- Concerns exist regarding the use of multiplex panels as first-line tests, suggesting limitations may be warranted.
Conclusions:
- The adoption and utilization of multiplex PCR panels present complex decisions for healthcare institutions.
- Balancing comprehensive diagnostics with cost-effectiveness and appropriate utilization remains a key challenge.
- Further discussion is needed to establish optimal guidelines for the use of multiplex PCR panels in clinical practice.
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