What is the difference between method validation and method verification?

Generally, verification confirms that an unmodified, previously cleared or approved test performs as stated by the manufacturer in your laboratory. Validation establishes performance characteristics for a laboratory-developed or modified test. Under CLIA, laboratories must establish performance specifications for tests they develop or modify.

Can you review validation data we have already generated?

Yes. We review existing datasets, identify gaps against the intended claims, and recommend supplementary studies or reporting changes where needed.

Service 02

Analytical Validation & Method Verification

A defensible analytical validation is built on a well-designed plan, appropriate acceptance criteria and clear reporting. We help laboratories design, execute and document validation and verification studies that withstand review.

Schedule a Consultation Ask a question

Scope of support

What this engagement covers

Accuracy and agreement studies
Precision and reproducibility
Analytical sensitivity / limit of detection (LoD)
Linearity or reportable range, as applicable
Inclusivity / exclusivity and cross-reactivity
Interference and carryover
Stability studies
Instrument and site comparability

What you can expect

Validation studies matched to the intended use of the test
Pre-defined acceptance criteria and traceable data
Reports written for laboratory directors, inspectors and reviewers

FAQ