Point-of-care testing includes lateral-flow rapid tests, handheld blood analyzers (i-STAT), portable molecular platforms (Cepheid GeneXpert, BioFire), and at-home tests. Designed for short turnaround and minimal training. Point-of-care tests run near the patient, such as in clinics, pharmacies or homes, and give fast results. Many seek CLIA waiver so they can be used outside traditional labs. Ease of use, accuracy in untrained hands and connectivity to records are key design factors.

Why it matters

CLIA-waived status unlocks the largest commercial markets (physician offices, urgent care, retail pharmacy, OTC). Reimbursement via CPT 87xxx codes with site-of-service modifiers.

Common pitfalls

•A common pitfall is underestimating the human factors engineering challenges associated with diverse user populations and uncontrolled use environments.
•Failing to adequately validate performance characteristics, such as accuracy and precision, in the actual point-of-care setting can lead to significant regulatory issues.
•Misinterpreting CLIA waiver requirements or failing to secure the appropriate CLIA status can severely limit market access and legal distribution.
•Inadequate cybersecurity measures for connected point-of-care devices can pose significant risks to patient data and device functionality, leading to non-compliance with FDA pre-market and post-market cybersecurity guidance.
•Not addressing shelf-life stability and environmental tolerances for storage and transport, which are often more varied in point-of-care settings, is a common oversight.

Sources

AACC POC · AACC
MedTech Dive · MedTech Dive
AdvaMed - Industry Reports · AdvaMed
Point-of-care diagnostics · U.S. Food and Drug Administration (FDA)

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Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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