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

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.

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

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.