Performance evaluation on Roche urine trace albumin detection reagent kit
10.3969/j.issn.1673-4130.2016.15.003
- VernacularTitle:罗氏尿微量清蛋白检测试剂盒性能评价
- Author:
Qinfeng HUANG
;
Shaoling HUANG
;
Meizhu WANG
;
Min CHEN
- Publication Type:Journal Article
- Keywords:
urine trace albumin;
precision;
linear range;
reportable range;
carry over pollution;
specific protein in-strument
- From:
International Journal of Laboratory Medicine
2016;37(15):2055-2057
- CountryChina
- Language:Chinese
-
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 evaluation :with 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 range :the 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 assessment :the 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 precision :low concentration CV=1 .98% .high concentration CV=1 .64% ;intermediate precision :low concentration CV=4 .35% , high concentration CV=1 .20% ;the linear range verification :the measurement range 5 .6-413 .55 mg/L ;clinical reportable range :in the maximum diluted multiples of 30 times ,the clinical reportable range was 5 .6-12 406 .5 mg/L ;the carry over pollution rate :serum albumin (42 .6 g/L) on urine trace albumin(6 .9 mg/L) ,the carry over pollution rate was 0 .28% ;the indoor comparison :in 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 .
