Molecular point-of-care testing in the community pharmacy setting: current status and future prospects
Michael Klepser1, Renee R Koski1
1Pharmacy Practice Department, Ferris State University College of Pharmacy, USA.
Expert Review of Molecular Diagnostics
|October 21, 2022
Summary
Community pharmacies are increasingly offering Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care tests (POCTs). Overcoming barriers like workflow and reimbursement is key to expanding rapid infectious pathogen testing services.
Area of Science:
- Clinical diagnostics
- Point-of-care testing
- Community pharmacy practice
Background:
- Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care tests (POCTs) have been available since the late 1980s.
- Their utilization in community pharmacy settings has significantly increased in recent years.
- Existing challenges include pharmacy workflow, pharmacist scope of practice, and reimbursement issues.
Purpose of the Study:
- To present a comprehensive review of CLIA-waived rapid point-of-care infectious pathogen testing in community pharmacies.
- To highlight the current state and trends in pharmacy-based POCT.
Main Methods:
- Review of available CLIA-waived rapid POCTs for community pharmacy settings.
- Analysis of factors influencing POCT implementation in pharmacies.
- Discussion of existing data on pharmacy-based POCT programs.
Main Results:
- Several lateral flow and nucleic acid amplification CLIA-waived POCTs are available for community pharmacies.
- Lateral flow tests for influenza and acute pharyngitis are most commonly reported in pharmacy-based programs.
- Pharmacy participation in POCT programs is growing as barriers are addressed.
Conclusions:
- Understanding available CLIA-waived rapid POCTs and their characteristics is crucial for pharmacy integration.
- Test selection depends on pharmacy workflow, patient demographics, and state regulations.
- Evolving nucleic acid amplification tests will clarify the business case for molecular testing in community pharmacies.
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