Regulatory Approach to Point-of-Care/At-Home Testing in the United States.

Area of Science:

• Clinical diagnostics
• Laboratory regulation

Background:

• The Clinical Laboratory Improvement Amendments (CLIA) were established in the 1990s.
• CLIA categorizes laboratory tests into waived, moderate, and high complexity.
• These regulations were developed in partnership with the Centers for Medicare and Medicaid Services and the Food and Drug Administration.

Purpose of the Study:

• To explain the CLIA classifications.
• To highlight the role of waived testing.
• To discuss the impact of the COVID-19 pandemic on laboratory testing.

Main Methods:

• Review of CLIA regulations and historical context.
• Examination of Food and Drug Administration (FDA) approvals for waived tests.
• Analysis of testing methodologies during the COVID-19 pandemic.

Main Results:

• CLIA classifications include waived, moderate, and high complexity testing.
• Waived testing allows laboratories to perform specific FDA-approved tests.
• The COVID-19 pandemic accelerated the approval and use of molecular and antigen tests, including for at-home use.

Conclusions:

• CLIA regulations provide a framework for laboratory test complexity.
• Waived testing has expanded, particularly with emergency use authorizations.
• Laboratory testing, including waived and at-home options, plays a crucial role in public health, as demonstrated during the COVID-19 pandemic.