ABSTRACT
Objective: To evaluate and eliminate the potential bias between data obtained from dry and liquid biochemical assays, making data obtained by different assays matchable. Methods: Bias estimation was performed based on document EP9-. A2. Simple data comparison and methodology validation were performed after the experiment methods were modified with the estimated correction factors and interception. All the collected data were analyzed by EXCEL2007 software. Results: The predicted bias of 4 of the 10 compared items exceeded their corresponding acceptable bias. After being adjusted by the coefficient and interception obtained from linear regression analysis, the four bias was improved and was within the acceptable range. The results of simple data comparison further confirmed this comparability. Conclusion: Based on EP9-A2, we have established a protocol to obtain a consistency of data from different biochemical analyzers, which makes it possible that the detection results of the same patient from different detection systems can be used directly. The protocol has been approved by the experts during the medicinal laboratory accreditation of ISO15189.
ABSTRACT
Objective To evaluate and eliminate the potential bias between data obtained from dry and liquid biochemical assays,making data obtained by different assays matchable.Methods Bias estimation was performed based on document EP9-A2.Simple data comparison and methodology validation were performed after the experiment methods were modified with the estimated correction factors and interception.All the collected data were analyzed by EXCEL2007 software.Results The predicted bias of 4 of the 10 compared items exceeded their corresponding acceptable bias.After being adjusted by the coefficient and interception obtained from linear regression analysis,the four bias was improved and was within the acceptable range.The results of simple data comparison further confirmed this comparability.Conclusion Based on EP9-A2,we have established a protocol to obtain a consistency of data from different biochemical analyzers,which makes it possible that the detection results of the same patient from different detection systems can be used directly.The protocol has been approved by the experts during the medicinal laboratory accreditation of ISO15189.