Analytical Validation
Analytical validation examines whether a measurement method measures its intended target with performance suitable for its stated use.
#Start with the measurement and intended purpose
The FDA-NIH BEST resource explains analytical validation as establishing that a test measures what it is intended to measure. Its glossary describes technical performance characteristics such as accuracy, precision, sensitivity and specificity under a specified protocol.
Read exactly what is being measured, by which method and for what use. A statement that a test is validated should identify the measurement and performance being evaluated. Technical validity does not by itself establish clinical usefulness or suitability for a different purpose.
Evidence: FDA-NIH BEST: validation and intended purpose / FDA-NIH BEST: analytical validation, clinical validation and utility
#The protocol and conditions shape performance
BEST notes that the technical protocol can include specimen collection, handling and storage. The archived CDC ACCE questions for genetic tests ask about repeated measurements, within- and between-laboratory precision, tested specimens and failures to produce a usable result.
Read which conditions were examined and whether they match the intended workflow. A method's performance under one set of conditions does not establish performance under every condition. These sources provide concepts and genetic-testing examples, not a complete laboratory validation procedure or acceptance threshold.
Evidence: FDA-NIH BEST: analytical validation, clinical validation and utility / CDC archive: questions for genetic-test validity and utility
#Comparisons need an appropriate reference
The proposed V3 digital-measurement framework describes comparing processed metrics with appropriate reference measurements. It emphasizes that reference methods have their own limitations and that no single accuracy threshold is suitable for all metrics and reference standards.
Read how the reference obtains its measurement and why it is appropriate for the target. Agreement with an imperfect comparison can obscure rather than remove error. V3 is a peer-reviewed framework proposed for biometric monitoring technologies, not a universal regulatory standard for all tests.
Evidence: Goldsack et al. (2020): proposed digital-measurement validation framework
#Technical performance is one part of evaluation
BEST distinguishes analytical validation from clinical validation and clinical utility. CDC's historical ACCE framework separately examines analytic validity, clinical validity, utility and ethical, legal and social implications for genetic tests.
Read which evaluation step a claim actually supports. Accurate measurement can still be clinically uninformative or lead to no worthwhile change in care. Mynd has not validated a test, processed patient specimens or provided a laboratory service on this page.
Evidence: FDA-NIH BEST: analytical validation, clinical validation and utility / CDC archive: ACCE genetic-test evaluation framework
Source note
The sections above were checked against the linked sources. No clinical review has been performed. This is general research education, not a clinical guideline.