关键词: Cobas8000生化分析仪, 国产试剂, 性能验证

Abstract:

Objective： To verify the performance of 11 domestic Leadman^® detection reagents in the newly purchased Roche Cobas8000 biochemical analyzer.Method： According to the requirements of ISO15189 and referring to the industry standards of National Health Commission， the performance of 11 domestic Leadman^® detection reagents ［creatinine（CREA），α-Hydroxybutyrate dehydrogenase （HBDH）， prealbumin（PA）， C-reactive protein（CRP）， hypersensitive C-reactive protein （hsCRP）， lipoprotein a（Lpa）， apolipoprotein A1 （APOA1）， cystatin C（Cys-C）， β2-microglobulin（β2-MG），homocysteine （HCY）and serum amyloid A （SAA）］ were evaluated in Roche Cobas8000 biochemical analyzer for the precision， accuracy， linear range， and reference interval.Results： The precision within the batch is less than 1/4 of the allowable total error （TEa）， which meets the requirements. The inter batch precision is less than 1/3 TEa， which meets the requirements. In trueness verification， the results of external quality assessment （EQA） were more than 80% qualified， which meets the requirements. The linear range r²>0.95， maximum dilution ratio， and application reference interval referenced by each testing item meet the requirements.Conclusion： The 11 domestic Leadman^® detection reagents meet the quality requirements for test in the newly purchased Roche Cobas8000 biochemical analyzer and can be used in clinical practice.

Key words:  , Roche Cobas8000 biochemical analyzer； , Leadman detection reagents； , Performance verification