A Feasibility Analysis of Mutual Recognition of Test Results Between Two Common Blood Cell Analysis Detection Systems Using Inter-laboratory Quality Assessment Datasets
Objective To explore the feasibility of mutual recognition of blood cell analysis test results between two main detection systems using inter-laboratory quality assessment datasets from Nanjing city.Methods The inter-laboratory quality assessment datasets from two sessions in 2023 in Nanjing city were analyzed.SPSS 25.0 was applied for data processing and statistical analysis.Results The number of participants in the inter-laboratory quality assessment for blood cell analysis increased yearly:259 in 2021,265 in 2022,and 267 in 2023,with no statistically significant difference in the pass rate of inter-laboratory quality assessment among medical institutions of different grades.There was no significant difference in the median values of WBC count,RBC count,Hgb,and PLT count projects among the batches of samples from the Mindray group and the Sysmex group,and the coefficients of the variation were all within the allowable ranges.For Hct,MCV,and MCH projects,the median values of the two instruments also showed no significant difference,but the coefficients of the variation did not all meet the industry standard requirements,with the Sysmex instrument group outperforming the Mindray instrument group.For MCHC project,in addition to the difference for median values,the coefficients of the variation did not meet the standards.Although other instrument groups did not show significant differences in median values compared to the Mindray and Sysmex groups,their intra-group coefficients of the variation did not comply with industry standards.Conclusion Monitoring inter-laboratory quality assessment data can serve as one of the reference bases for the supervision of mutual recognition of blood cell analysis test results.The clinical laboratory test results of various medical institutions in Nanjing city are generally consistent for the four items of WBC count,RBC count,Hgb,and PLT count on both Mindray and Sysmex instruments,meeting the requirements for mutual recognition of results,while observed differences between the Mindray and Sysmex detection systems can be temporarily disregarded.
Inter-laboratory quality assessmentBlood cell analysis systemComparabilityConsistencyMutual recognition of test results