Molecular point-of-care testing in the community pharmacy setting: current status and future prospects

ABSTRACT

Introduction

Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care tests (POCTs) have been available since the late 1980s, but their use in community pharmacy has expanded over the last several years. Barriers exist for community-pharmacy-based CLIA-waived POC testing, including pharmacy workflow, pharmacist scope of practice, and reimbursement. As pharmacies work to reduce these barriers, the number of pharmacies participating in POCT programs has dramatically increased. There are several lateral flow and nucleic acid amplification CLIA-waived POC tests available for use in community pharmacy settings. The majority of data regarding pharmacy-based POC testing programs currently highlights the role of lateral flow testing for influenza and acute pharyngitis.

Areas Covered

A comprehensive review of the current state of CLIA-waived rapid point-of-care infectious pathogen testing in community pharmacies is presented.

Expert Opinion

Knowing which CLIA-waived rapid POCTs are available and understanding their key characteristics will be helpful in identifying the best tests to incorporate into individual pharmacies. Choices will also depend on specific pharmacy workflow patterns, local populations and insurances, and state regulations regarding pharmacist scope of practice. As nucleic acid amplification tests evolve, the business case and the framework for implementation for using molecular tests in community pharmacy will become clearer.

KEYWORDS:

• Community pharmacy
• pharmacist
• point-of-care test
• molecular
• CLIA-waived
• diagnostic

Article highlights

• The number of pharmacies in the United States that possess a certificate of waiver increased from 12,157 in 2019 to 24,984 in 2021.

• Pharmacy-based care models continue to grow and fall into one of three categories: Test-and-Treat, Test-and-Monitor, and Test-and-Link.

• Expansion in CLIA-waived molecular diagnostics has resulted in an increase in the types of pathogens that can be detected and services offered in pharmacies.

• Although CLIA-waived testing and disease management services have been increasing, the ability to act on test results and receive reimbursement for services remain significant barriers to even broader expansion.

Declaration of interest

Dr. Klepser has research grants from Genentech and Janssen, and he consults for Qorvo, LabSimply, and BD. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.