The performance verification of high-sensitive C reactive protein test reagent
10.3969/j.issn.1673-4130.2014.17.019
- VernacularTitle:超敏C反应蛋白检测试剂性能验证
- Author:
Zhiying HU
;
Mei HU
;
Man ZHANG
- Publication Type:Journal Article
- Keywords:
high-sensitive C reactive protein;
comparison test;
consistency
- From:
International Journal of Laboratory Medicine
2014;(17):2313-2314
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the accuracy,repeatability and consistency with contracting reagent of the high-sensitive C reac-tive protein(hs-CRP)test by using the independently developed reagents.Methods 150 samples were collected,including 130 ser-um samples and 20 plasma samples.4 times of the relative difference of mean value was used as the detection limits,and the regres-sion analysis was performed after excluding 5 sample outliers,then calculated the expected bias at medical decision level with the 95% confidence interval,in order to judge whether the bias was within the allowable range.Results The recovery rate of hs-CRP test reagent were within the allowable range which was 90% -110%.The hs-CRP testing results of plasma and serum samples from the same source were consistent,and the expected bias of medical decision level was in the permissible range.Conclusion The developed reagent used in hs-CRP test have good accuracy,repeatability,and highly consistency with control reagent.
