GlossaryofTermsusedinISTAMethodValidationStudies.docVIP

GLOSSARY GLOSSARY OF TERMS USED IN ISTA METHOD VALIDATION STUDIES Accuracy Bias Certification Mark Comparative Test Critical Control Point Cross Reactivity Error Error of Measurement Random Error Systematic Error Fitness for Purpose Limit of Detection Limit of Quantitation Linearity Measurand Measurement Method (of a measurement) Multi-laboratory Study Peer Review Peer Validation Performance Approved Method Performance Based Method Performance Validated Method Precision Intermediate Precision Measurement Precision Proficiency Testing Quality Quality Assurance Quality Control Internal Quality Control Recovery Reference Material Certified Reference Material Repeatability Reproducibility Result of a Measurement Ruggedness Test Specified Traits Sponsor Standard Deviation Test Kit Test Organiser Test Plan Test Report Traceability Trueness Uncertainty (of Measurement) Validation Method Validation Value Accepted Reference Value True Value Verification  Accuracy: ‘The closeness of agreement between a test result and the accepted reference value.’ Note: The term accuracy, when applied to a set of test results, involves a combination of random components and a common systematic error or bias component. [ISO 3534-1]. Accuracy (of Measurement): ‘Closeness of the agreement between the result of a measurement and a true value of the measurand.’ Accuracy (of a Measuring Instrument): ‘Ability of a measuring instrument to give responses close to a true value.’ Note: In these contexts accuracy is a qualitative concept.’ [IUPAC ‘Orange’ Book]. The term ‘precision’ should not be used for ‘accuracy’. [VIM, 1993]. Bias: ‘The difference between the expectation of the test results and an accepted reference value.’ Note: Bias is the total systematic error as contrasted to random error. There may be one or more systematic error components contributing to the bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value.’ [ISO 3534-1] Bias (of