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Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for
Patti Shih1, Sverre Sandberg2,3,4,5, Jan Balla6
1Australian Centre for Health Engagement Evidence and Values, School of Health & Society, 8691 University of Wollongong , Wollongong, Australia.
Clinical Chemistry and Laboratory Medicine
|August 14, 2024
Summary
Direct-to-consumer testing (DTCT) involves consumers ordering lab tests without healthcare professionals. Defining DTCT by "consumer initiation" clarifies benefits, harms, and regulatory needs for these growing commercial tests.
Area of Science:
- Laboratory Medicine
- Consumer Health
- Health Policy
Background:
- Direct-to-consumer testing (DTCT) is a growing market of commercial laboratory tests ordered by individuals without clinician involvement.
- The expansion of DTCT necessitates a clear definition to understand its potential harms and benefits.
- Existing definitions may not fully capture the nuances of various DTCT modalities.
Purpose of the Study:
- To define Direct-to-consumer testing (DTCT) by emphasizing "consumer initiation" as a core characteristic.
- To analyze how different DTCT modalities impact the traditional laboratory testing process.
- To propose recommendations for improving DTCT quality and reducing errors.
Main Methods:
- Conceptual analysis of DTCT modalities: home self-testing, self-sampled tests, and direct access tests.
- Comparison of DTCT with traditional, clinician-ordered laboratory testing ('brain-to-brain loop').
- Examination of implications for consumers and the healthcare system.
Main Results:
- Three DTCT modalities present unique challenges to the standard testing pathway.
- The distinction between medical and non-medical laboratories is relevant in DTCT.
- "Consumer initiation" is identified as a key differentiator for DTCT.
Conclusions:
- A clear definition centered on "consumer initiation" is crucial for understanding DTCT's drawbacks and opportunities.
- This definition can inform DTCT regulation and guide efforts to support consumers in making informed decisions.
- Considering the implications for health outcomes and healthcare resource utilization is vital.
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