Roche Molecular Systems, Inc., Pleasanton, CA 94588, USA.
J Virol Methods. 2010 May;165(2):246-53. doi: 10.1016/j.jviromet.2010.02.004. Epub 2010 Feb 10.
Clinical specificity, analytical and clinical sensitivities, reproducibility, and subtype/genotype coverage of the cobas TaqScreen MPX Test, a multiplex nucleic acid test with expanded coverage of HIV variants, were determined. A total of 72,281 blood donations were evaluated. The 95% limit of detection (LOD) for the MPX Test inclusive viruses was determined by testing six dilutions of WHO or Roche standards. Over 3000 high-risk and confirmed seropositive specimens were tested with the MPX and COBAS AmpliScreen Tests. Ten subtypes of HIV-1 Group M, HIV-1 Group O, HIV-2 A and B, HBV genotypes A-H, and HCV genotypes 1-6 were tested with the MPX Test. Reproducibility panels were evaluated at three testing sites across three lots. Clinical specificity in pools was 99.99%. There was one HBV yield case. The LODs for HIV-1 Group M, HCV, and HBV were 49, 11, and 3.8 IU/mL, respectively, and 89 and 59.3 copies/mL for HIV-1 Group O and HIV-2, respectively. Concordance between the MPX and the AmpliScreen Tests was 94.9%. Clinical sensitivity based on AmpliScreen comparison was 97.8-99.5%. All genotype/subtype replicates were detected at three times the LOD. Reproducibility was 98.3-100%. In conclusion, the MPX Test is robust and covers HIV-1 Group O and HIV-2.
对 cobas TaqScreen MPX 检测（一种具有扩展的 HIV 变体覆盖范围的多重核酸检测）的临床特异性、分析和临床灵敏度、重现性以及亚型/基因型覆盖率进行了评估。评估了 72281 份血液样本。通过测试六个 WHO 或罗氏标准的稀释度，确定了 MPX 测试含病毒的 95%检测限（LOD）。使用 MPX 和 COBAS AmpliScreen 检测对超过 3000 份高危和确认的血清阳性样本进行了检测。使用 MPX 测试检测了 HIV-1 组 M、HIV-1 组 O、HIV-2 A 和 B、HBV 基因型 A-H 和 HCV 基因型 1-6 的 10 种亚型。在三个测试地点的三个批次评估了重现性面板。池中的临床特异性为 99.99%。有一个 HBV 产量案例。HIV-1 组 M、HCV 和 HBV 的 LOD 分别为 49、11 和 3.8 IU/mL，HIV-1 组 O 和 HIV-2 的 LOD 分别为 89 和 59.3 拷贝/mL。MPX 和 AmpliScreen 测试之间的一致性为 94.9%。基于 AmpliScreen 比较的临床灵敏度为 97.8-99.5%。所有基因型/亚型的重复检测均在 LOD 的三倍时被检测到。重现性为 98.3-100%。总之，MPX 检测具有稳健性，可覆盖 HIV-1 组 O 和 HIV-2。
