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Home and Clinical Laboratory Improvement Amendments-Waived Testing for Infectious Diseases-How Do These Fit in the
1Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, 4650 Sunset Boulevard, Los Angeles, CA 90027, USA.
Clinics in Laboratory Medicine
|January 27, 2024
Summary
Waived testing for infectious diseases is increasing patient access to rapid results, including at home. However, balancing accessibility with quality assurance remains crucial for these widely available clinical tests.
Area of Science:
- Clinical diagnostics
- Infectious disease testing
- Public health
Background:
- Traditional infectious disease testing occurs in clinical laboratory settings.
- Waived testing offers broader patient access to rapid diagnostic results.
- Home testing is expanding the reach of infectious disease diagnostics.
Purpose of the Study:
- To review the current landscape of waived infectious disease testing.
- To identify opportunities for ensuring optimal quality in waived testing.
- To address the balance between accessibility and quality in decentralized testing.
Main Methods:
- Literature review of waived infectious disease tests.
- Analysis of current trends in diagnostic accessibility.
- Exploration of quality assurance frameworks for decentralized testing.
Main Results:
- Waived testing significantly enhances patient access to timely infectious disease results.
- The expansion of home testing presents new challenges for quality control.
- Balancing increased accessibility with robust quality assurance is essential for reliable diagnostics.
Conclusions:
- The expansion of waived and home testing for infectious diseases requires careful consideration of quality assurance.
- Strategies must be developed to maintain high standards in decentralized diagnostic settings.
- Optimizing quality in waived testing is key to leveraging its benefits for public health.
