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《Chinese Journal of Blood Transfusion》 2019-01
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The performance validation of a nucleic acid test system before blood screening

LI Junying;WANG Yifang;GE Wenchao;WANG Xu;FANG Jianhua;Henan Red Cross Blood Center;  
Objective To evaluate the performance of the BACME nucleic acid test system, ensuring valid performance before its application in actual blood screening. Methods The operation function of BACME system was evaluated by throughput test, stress test and precision test of internal control(IC). Sensitivity analysis was performed according the instruction handbook. Verification of anti-cross contamination tests was also conducted to evaluate system accuracy and anti-cross contamination. The general application performance was evaluated by the parallel test cobas s201 system. Results The BACME system took 9 hours and 10 minutes to complete a batch of 752 specimens at full capacity with no error occurred during the stress test. In the precision test, the Ct of DNA IC was 30.68±0.12, CV was 0.56%, and the Ct of RNA IC was 30.12±0.16, CV was 0.53%. Only one 20 IU/mL HIV RNA specimen was not detected. 2 383 Negative specimens and 2 HBV DNA positive specimens were in consistence with the results of the cobas s201 system in the parallel test. Conclusion The performance of the BACME nucleic acid test system is in accordance with the expected requirements and meets the practical detection requirements.
【CateGory Index】: R457.1;R440
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【Citations】
Chinese Journal Full-text Database 1 Hits
1 TIAN Yunbo;LI Wei;QIN Weifei;HUANG Xia;DUAN Hengying;LIAO Hongwen;Chongqing Blood Center;;A performance qualification method of blood virus nucleic acid testing instrument before using[J];临床血液学杂志(输血与检验);2015-01
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