The guideline C24 (now in its 4th edition) issued by the Clinical and Laboratory Standards Institute (CLSI) recommends that for purchased quality control (QC), the laboratory should never use the… Click to show full abstract
The guideline C24 (now in its 4th edition) issued by the Clinical and Laboratory Standards Institute (CLSI) recommends that for purchased quality control (QC), the laboratory should never use the manufacturer’s declared target (T) value but that identified by testing the product at least ten times with each new batch (1). Of course, verifying T is quite different from estimating the variability of the analytical process, albeit both are used for the statistical process control (SPC) since T should be the production target of the QC material on which the manufacturer has complete control.
               
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