2009, Number 1
Validation and verification of methods of laboratory applied to blood bank
Baptista GHA, Santamaría-Hernández MC, Martínez-Reyes CS, Muñoz-Carmona M
Full text
Language: Spanish
References: 7
Page: 20-29
PDF size: 133.08 Kb.
ABSTRACT
Validation and verification of methods of a laboratory applied to Blood Bank. The validation and verification are a series of indispensable activities on pre-analytical phase that comprise the securing of quality and hit in the result, that from the point of view of the clinical laboratory is in an asked for examination and these concepts are migrating to a Blood Bank, hitting on blood products quality and results of the patient or arranger. The validation allows to confirm by the analysis and demonstrates objective, the fulfillment of specifications of performance of the method or equipment, whereas the verification is a comparison of method’s results in same the conditions of the own Blood Bank against of the manufacturer method’s. The requirements for the validation included: Linearity (analytical interval), precision, veracity, detection limit, selectivity, analytical sensitivity, interval of work, analytical specificity and uncertainty. In the verification process, the laboratory must evaluate: Linearity (analytical Interval), precision, veracity and uncertainty.REFERENCES