Establishing and maintaining performance claims. A manufacturer's viewpoint

Area of Science:

• Clinical laboratory science
• Analytical chemistry
• Medical diagnostics

Background:

• Manufacturers communicate analytic capabilities via performance claims.
• Claims must be meaningful, achievable, and verifiable for laboratory users and regulatory agencies.
• Lack of standardized guidelines complicates performance claim interpretation and inter-method comparison.

Purpose of the Study:

• To focus on analytical performance characteristics: precision, accuracy, and specificity.
• To describe how manufacturers establish, validate, maintain, and monitor these claims.
• To outline how end-users can verify these performance claims.

Main Methods:

• Discussion of precision claims, encompassing short-term and long-term variability.
• Examination of accuracy claims, noting challenges due to lack of objective standards and reliance on comparative methods.
• Review of specificity claims, based on manufacturer screening and user feedback regarding interference and cross-reactivity.

Main Results:

• Precision claims vary based on included variance components and may be stated as typical or minimum expected performance.
• Establishing and verifying accuracy claims is challenging; few manufacturers provide true accuracy claims, often using comparative methods.
• Specificity claims rely on screening and user feedback, with no consensus on clinically significant interference criteria or consistent disclosure methods.

Conclusions:

• Clear, unambiguous performance claims are essential for meaningful method evaluation.
• Standardized guidelines are needed to improve consistency in stating and verifying precision, accuracy, and specificity claims.
• Ongoing efforts by organizations like the National Committee for Clinical Laboratory Standards aim to develop consistent guidelines for performance claims.