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Verification of method performance for clinical laboratories.

James H Nichols¹

¹Tufts University School of Medicine and Baystate Health, Springfield, Massachusetts 01199, USA. james.nichols@baystatehealth.org

Advances in Clinical Chemistry

|July 29, 2009

Summary

Method verification confirms a test system

Area of Science:

Clinical Chemistry and Laboratory Medicine
Diagnostic Test Performance Evaluation
Quality Standards in Healthcare

Background:

Method verification and validation are critical but often confused processes in laboratory diagnostics.
International standards (ISO, CLSI), accreditation guidelines (CAP, Joint Commission), and regulations (CLIA'88) govern these procedures.
Accurate test system performance is essential for reliable patient testing.

Purpose of the Study:

To clarify the distinction between method verification and method validation.
To compare diverse recommendations for method verification from various regulatory and accreditation bodies.
To highlight the importance of appropriate verification for marketed test kits and modified laboratory methods.

Main Methods:

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Comparative analysis of international quality standards, accreditation guidelines, and regional laws.

Discussion of Clinical Laboratory Standards Institute (CLSI) evaluation protocols (EP).

Review of essential performance characteristics for method verification (accuracy, precision, analytic measurement range, reference intervals).

Main Results:

Method verification is a one-time check before patient testing, while validation establishes performance for new or modified methods.
Marketed test kit users must verify accuracy, precision, analytic measurement range, and reference intervals.
New or modified methods may require more extensive validation, including analytic sensitivity and specificity.

Conclusions:

Clear understanding and application of method verification and validation are crucial for laboratory quality.
Laboratories should utilize established guidelines and protocols (e.g., CLSI EP) for robust verification processes.
Adherence to standards ensures the reliability and safety of diagnostic testing in patient care.