Clinical Significance of Non-Linear Performance in Calibration Verification/ Linearity Experiments

Healthcare providers rely heavily on the information from laboratory testing to aid in diagnosis, treatment, and management of patient care. Laboratories employ clinical analyzers to carry out diagnostic tests and the performance of these instrument systems must be validated to ensure consistently accurate and reliable results.

This whitepaper will discuss:

• Calibration verification (CalVer) regulations
• Key terminology and concepts used in CalVer testing
• Commercial CalVer/linearity test kits and data reduction software
• Setting acceptable performance criteria
• Ascertaining the clinical significance of non-linearity
• Dealing with non-linearity, including troubleshooting and peer group analysis