Performance test and evaluation of ADVIA Centaur XP automatic chemiluminescence immunoassay system
10.3969/j.issn.1673-4130.2018.03.010
- VernacularTitle:ADVIA Centaur XP全自动化学发光免疫分析系统的性能验证及评价
- Author:
Yue ZHANG
1
;
Zhenfang DONG
;
Ying JU
;
Yiqing LIU
;
Yong WANG
;
Bingchang ZHANG
Author Information
1. 山东大学附属省立医院临床医学检验部
- Keywords:
chemiluminescence immunoassay instrument;
performance verification;
thyroid gland hormones
- From:
International Journal of Laboratory Medicine
2018;39(3):289-292
- CountryChina
- Language:Chinese
-
Abstract:
Objective The ADVIA Centaur XP automatic chemiluminescence immunoassay system detec-tion performance of the thyroid hormones and antibodies for validation and evaluation.Methods With refer-ence to the American association of clinical laboratory standardization guide and other related documents,the ADVIA Centaur XP automatic chemiluminescence immunoassay system test 7 items thyroid hormones and an-tibodies(T3,T4,FT3,FT4,TSH,anti-TG,anti-TPO)of precision,accuracy,linear range and carry pollution rate for validation.Results Within the seven thyroid hormones and antibodies batch testing precision of CV and CV between batch precision between 1.51% -6.17% and 1.86% -6.17%.Is the average accuracy of bias of the largest testing project FT3(8.47%),but in the acceptable range,good correlation,correlation coefficient R of 0.994 or higher,Average bias <1/2 CLIA′88 TEa(12.5%).T3,T4,FT3,FT4,TSH,anti-TG and anti-T PO in 1.24-5.59 nmol/L respectively,and 60.07 -195.10 nmol/L,3.40 -22.87 pmol/L,14.59 -40.54 pmol/L,1.63-74.13 μIU/mL,60.10 -381.30 μIU/mL and 180.10 -531.50 μIU/mL range is linear,Carry pollution rate is between 0.04% -0.97%.Conclusion ADVIA Centaur XP automatic chemiluminescence im-munoassay system detecting thyroid hormones and antibodies results consistent with the data provided by the manufacturer,the test results are accurate and reliable,and can be used for the detection of clinical samples.
