Performance verification of four nucleic acid detection systems: A comparitve study
10.13303/j.cjbt.issn.1004-549x.2021.09.025
- VernacularTitle:核酸检测系统的性能验证
- Author:
Miao LIU
1
;
Tong PAN
1
;
Xia WANG
1
;
Na YAO
1
;
Qian ZHAO
1
Author Information
1. Tianjin Blood Center, Tianjin 300110, China
- Publication Type:Journal Article
- Keywords:
nucleic acid detection;
performance verification;
serum plate;
Probit regression;
Kappa test
- From:
Chinese Journal of Blood Transfusion
2021;34(9):1032-1035
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To compare the analytical performance of Tigris, Panther, ChiTaS BSS1200 and cobas S201 system to see if they satisfy the requirements of blood screening and to know the concordance of the results presented by these four systems. 【Methods】 According to the relevant documents of ISO15189 and Standard Operating Procedure of Blood Station(2019), the parameters needed to be verified for nucleic acid tests(NAT) included: analytical sensitivity verification, system compare test, anti-jamming capability and anti-cross-contamination ability. 【Results】 The 95% detection limits of Tigris, Panther, ChiTaS BSS1200 and Cobas S201 for HBV-DNA(IU/mL), HIV-RNA(IU/mL) and HCV-RNA(IU/mL) were 2.013 vs 4 vs 2.995 vs 0.99, 13.039 vs 10.21 vs 30.952 vs 32.24, and 2.278 vs 2.077 vs 12.008 vs 3.39, respectively. In the performance comparison verification between NAT systems, the results of the two sets of Tigris systems were in full accordance with serum plate, with a concordance rate of 100%, Kappa value of 1, and none cross-contamination.The concordance rate of No.1 Panther system was 100%, and No.2 98%, with Kappa value of 0.961 and none cross-contamination. Hemolytic samples (5g/L Hb concentration) and lipemic blood samples (13.81 mmol/L TG concentration) had no significant effect on the detection of low-concentration samples. 【Conclusion】 No significant differences in the performance of NAT systems were notable by devices, as the four systems were fully automated with high sensitivity, which can fully satisfy the blood screening requirements. Panther system demonstrates superior analysis sensitivity in HCV-RNA/HIV-RNA and lower in HBV DNA, but also in required criteria, as compared to Tigris system. Neither hemolysis nor lipemic blood had any significant effect on the test results.
