两种进口HBV/HCV/HIV核酸筛查试剂的质量评价

Evaluation of Qualities of Two Imported Kits for Screening of HBV DNA, HCV RNA and HIV RNA

目的对Gen-Probe公司的Procleix Ultrio(Ultrio)和Roche公司的Cobas TaqScreen MPX(MPX)HBV/HCV/HIV核酸筛查试剂的质量进行初步评价。方法从我国不同地区收集60份HIV-1感染者样品(包括59份HIV抗体阳性样品和1份HIV抗体阴性的HIV-1感染窗口期样品)及540份HIV抗体阴性样品,将60份HIV-1感染者样品随机分布于540份HIV阴性样品中,按照合并检测模式对600份样品进行检测,并对每种试剂的检测结果为阳性的样品汇集池(pool)分别按其说明书进一步进行拆分和/或鉴别试验。结果 MPX试剂和Ultrio试剂的单一人份样品检测(Individual donor test,IDT)结果一致的样品共586份,二者的符合率为97.67%,MPX试剂共有12份样品检测结果为假阳性,Ultrio试剂共有6份样品检测结果为假阳性,4份样品MPX试剂检测为阳性,而Ultrio试剂检测为阴性,其核酸含量较低(1份样品HIV-1RNA<40cp/ml,3份样品HBV DNA<12cp/ml),由于无法完成跟踪随访,因此不能确定其最终感染状态。结论 MPX试剂和Ultrio试剂检测结果具有较高的一致性,但对于HBV DNA、HCVRNA和HIV-1RNA含量较低的样品,二者检测结果可能存在一定的差异。

Objective To preliminarily evaluate the qualities of Gen-Probe Procleix Ultrio （Ultrio）kit and Roche Cobas TaqScreen MPX（MPX）kit for screening of HBV DNA, HCV RNA and HIV RNA. Methods Sixty samples of patients infected with HIV-1, including 59 anti-HIV positive and 1 anti-HIV negative samples from a patient in window period, as well as 540 anti-HIV negative samples were collected from different regions in China. The 60 samples from patients infected with HIV-1 were randomly distributed in the 540 negative samples. Mini-pool test was performed on the 600 samples, and the pools with positive results by each kit were further subjected to discrimination and / or identity tests according to the manufacturer＇s instructions. Results The results of individual donor test （IDT）of 586 samples by MPX and Ultrio kits were in agreement, indicating a coincidence rate of 97. 67%. Twelve samples were judged as false positive by MPX kit, while 6 by Ultrio kit. Four samples judged as positive by MPX kit was fur-ther judged as negative by Ultrio kit, in which the nucleic acid contents were low （HIV-1 RNA 40 cp / ml in 1 sample and HBV DNA 12 cp / ml in 3 samples）. However, since the donors of the 4 samples could not be followed up, their final infection status could not be confirmed. Conclusion The test result by MPX kit was highly consistent with that by Ultrio kit. However, the test results of samples with low contents of HBV DNA, HCV RNA and HIV-1 RNA by the two kits might be different at a certain degree.