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《Chinese Journal of Blood Transfusion》 2014-04
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Evaluation on analysis function and operation performance of Procleix TIGRIS system at blood screening laboratory

YAO Fenglan;WANG Dehai;ZHA Wei;LENG Chan;WANG Zhongmei;YANG Haiping;ZHENG Jing;BAI Heqian;GE Hongwei;Blood Screening Laboratory,Beijing Red Cross Blood Center;  
Objective:To evaluate the analysis function and operation performance of Procleix TIGRIS System before Nucleic Acid Testing(NAT) which was implemented in blood screening laboratory;and to confirm the feasibility of Procleix TIGRIS System with the insurance of its efficient running that was under control.Methods We evaluated the the analysis function and operation performance of Procleix TIGRIS System,and we also compared the performance of different Procleix TIGRIS System.The WHO International Standards for HIV-1 RNA,HCV RNA,HBV DNA were used to determine the analysis sensitivity of the Procleix TIGRIS System.Severe hemolytic and midrange lipaemic blood samples with low-load of HIV,HCV and HBV virus was used to evaluate the Procleix TIGRIS System in the presence of endogenous,interfering substances,respectively.Samples containing high load of HBV( 106IU / ml) were used to evaluate the robustness of Procleix TIGRIS System against crosscontamination.The operation performance of Tigris System was evaluated from the throughput and stress test,the invalid work list and invalid run,and the stability of the assays.The performances of different Tigris Systems were compared by testing the same PT panels.Results 95% limits of detection(LODs) for HIV-1,HCV,HBV were 18.1 IU /mL(range from 12.2 ~ 36.9 IU /mL),7.4 IU /mL(range from 4.7 ~ 15.2 IU /mL),11.7 IU /mL(range from 7.6 ~ 22.5 IU /mL),respectively,for Procleix Ultrio Assay.And 16.3 IU /mL(range from 10.0 ~ 47.1IU /mL),5.8 IU /mL(range from 3.5 ~ 14.2 IU /mL),23.8 IU /mL(range from 13.0 ~ 61.6 IU /mL),respectively for Procleix Ultrio Discriminatory Assay on TIGRIS System.It was in coincidence with the analytic sensitivity provided by the manufacturer.No significant difference was observed between normal and severe hemolytic,midrange lipaemic blood samples for HIV(40 IU /mL),HCV(10 IU /mL),and HBV(20 IU /mL)on Procleix TIGRIS System.When Procleix TIGRIS System was challenged with no more than 10% positive samples( 106IU /mL) in a run,no cross-contamination was observed in negative samples;however,false-positive results owing to the aerosol could be found when the positive samples ratio increased to 20% or 50% in a run,but this aerosol did not truly contaminate the negative samples at all.Conclusion Procleix TIGRIS System was a fully automated NAT system with high sensitivity.The evaluation results of analysis function and operation performance of Procleix TIGRIS System before NAT implementation demonstrated our lab's capability on NAT.We also confirmed that hemolytic,lipaemic blood samples would not be an issue which might interfere to the NAT results significantly on Procleix TIGRIS System.Besides,there was no cross-contamination with no more than 10% positive samples in a run,which made NAT available to routine testing in our laboratory.The operation performance of Procleix TIGRIS System was very stable,and the homogenicity of different TIGRIS systems was high,and in accordant to the standards provided by the manufacture's instructions.
【Fund】: 卫生部卫生行业科研专项资助项目(201002005)
【CateGory Index】: R446.6
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