Evaluating the analytical performance of direct-to-consumer gut microbiome testing services

Area of Science:

• Microbiome research
• Consumer health products
• Analytical chemistry

Background:

• Growing consumer interest in personal microbiome health.
• Proliferation of direct-to-consumer (DTC) microbiome testing services.
• Uncertainty regarding the analytical validity, clinical validity, and safety of DTC tests.

Purpose of the Study:

• To evaluate the performance of DTC gut microbiome testing services.
• To identify discrepancies in results within and across providers.
• To highlight the need for industry standards.

Main Methods:

• Performance evaluation of seven DTC gut microbiome testing services.
• Utilized standardized human fecal material developed by NIST.
• Assessed analytical validity and methodological variability.

Main Results:

• Major discrepancies observed within and across different DTC microbiome testing providers.
• Variability between providers was comparable to biological variability between donors.
• Identified methodological variability and insufficient quality control as key issues.

Conclusions:

• Analytical performance is crucial for reliable clinical recommendations.
• Current DTC microbiome tests exhibit significant variability, impacting consumer confidence.
• There is a critical need for established standards to ensure analytical validity and consumer safety in the microbiome testing industry.