Performance evaluation on Roche urine trace albumin detection reagent kit / 国际检验医学杂志

ABSTRACT

Objective To evaluate the detection performance of the cobas8000 c702 fully automatic biochemical analyzer for de‐tecting the second generation Roche urine trace albumin (ALBU2) .Methods (1) The precise evaluationwith the allowable error stipulated by CLIA 88 as the basis ,the requirements were the repeat precision <1/4TEa ,and intermediate precision <1/3TEa;(2) the linear range and the evaluation of the reportable rangethe EP6‐A scheme was adopted ,and extend to calculate the average re‐covery rate of dilution ,the clinical reportable range was evaluated by the average dilution recovery of 90% -110% ;(3) the carry o‐ver pollution assessmentthe carry over pollution of serum albumin on urine trace albumin detection was evaluated by the judgment standard of carry over pollution rate of 0 .5% ;(4)the methodological comparative analysis:with SIEMENS BN Ⅱas the reference system ,the Roche Cobas 8000 C702 and the BN2 results were performed the correlation contrastive analysis .Results The repeat precisionlow concentration CV=1 .98% .high concentration CV=1 .64% ;intermediate precisionlow concentration CV=4 .35% , high concentration CV=1 .20% ;the linear range verificationthe measurement range 5 .6-413 .55 mg/L ;clinical reportable rangein the maximum diluted multiples of 30 times ,the clinical reportable range was 5 .6-12 406 .5 mg/L ;the carry over pollution rateserum albumin (42 .6 g/L) on urine trace albumin(6 .9 mg/L) ,the carry over pollution rate was 0 .28% ;the indoor comparisonin the concentration within 200 mg/L ,the regression line was Y=0 .896 X+5 .049 ,the correlation coefficient r2 =0 .994 4 ,the system shift was passed at the medical decision level .When the specimen concentration within 201-413 .55 mg/L ,the regression line was Y=0 .848X-10 .44 ,the correlation coefficient r2 =0 .917 ,the system shift was not passed at the medical decision level .Conclusion The detection of the Roche ALBU2 in the Cobas 8000 C702 platform can meet the clinical needs ,the comparison among different instruments has difference in different concentration ranges ,therefore the independent reference ranges should be established ac‐cording to the each instrument system .