Braun Patrick, Drago Monica, Fanti Diana, Fleury Hervé, Hofmann Jörg, Izopet Jacques, Kühn Sebastian, Lombardi Alessandra, Micheli Valeria, Sauné Karine, Trimoulet Pascale, Whittaker Duncan, Artus Alain, Rhodes Daniel
Laboratory Dr. Knechten, Medical Center for HIV and Hepatits, Aachen, Germany.
Clinical Chemistry and Microbiology Laboratories, Niguarda Ca' Granda Hospital, Milan, Italy.
J Clin Virol. 2017 May;90:18-25. doi: 10.1016/j.jcv.2017.03.006. Epub 2017 Mar 9.
Beckman Coulter has developed the VERIS HCV Assay for use on the new fully automated DxN VERIS Molecular Diagnostic System for HCV viral load monitoring.
Evaluate the clinical performance of the new quantitative VERIS HCV Assay.
Comparison was performed on 279 plasma specimens from HCV infected patients tested with the VERIS HCV Assay and COBAS Ampliprep/COBAS Taqman HCV Test and 369 specimens tested with the VERIS HCV Assay and RealTime HCV Assay. Patient monitoring sample results from four time points were also compared.
The average bias between the VERIS HCV Assay and the COBAS Ampliprep/COBAS Taqman HCV Test was 0.04 logIU/mL, while between the VERIS HCV Assay and the RealTime HCV Assay average bias was 0.21 logIU/mL. Bias, however, was not consistent across the measuring range. Analysis at the lower end of quantification levels 50, 100, and 1000IU/mL showed a predicted bias for VERIS HCV Assay versus COBAS Ampliprep/COBAS Taqman HCV Test between -0.42 and -0.22 logIU/mL and for VERIS HCV Assay versus RealTime HCV Assay between 0.00 and 0.13 logIU/mL. Patient monitoring of HCV viral load over time demonstrated similar levels between VERIS HCV Assay results and COBAS Ampliprep/COBAS Taqman HCV Test (52 samples from 13 patients) and RealTime HCV Assay (112 samples from 28 patients).
VERIS HCV Assay for use on the DxN VERIS Molecular Diagnostic System represents a reliable new tool for easy sample to result HCV RNA viral load monitoring.
贝克曼库尔特公司已开发出VERIS HCV检测法，用于新型全自动DxN VERIS分子诊断系统，以监测丙型肝炎病毒（HCV）载量。
评估新型定量VERIS HCV检测法的临床性能。
对279份来自HCV感染患者的血浆样本进行比较，这些样本分别采用VERIS HCV检测法和COBAS Ampliprep/COBAS Taqman HCV检测法进行检测，另外还对369份样本采用VERIS HCV检测法和实时HCV检测法进行检测。还比较了来自四个时间点的患者监测样本结果。
VERIS HCV检测法与COBAS Ampliprep/COBAS Taqman HCV检测法之间的平均偏差为0.04 logIU/mL，而VERIS HCV检测法与实时HCV检测法之间的平均偏差为0.21 logIU/mL。然而，偏差在整个测量范围内并不一致。在定量水平50、100和1000 IU/mL的下限进行分析时，VERIS HCV检测法相对于COBAS Ampliprep/COBAS Taqman HCV检测法的预测偏差在-0.42至-0.22 logIU/mL之间，VERIS HCV检测法相对于实时HCV检测法的预测偏差在0.00至0.13 logIU/mL之间。对HCV病毒载量随时间的患者监测表明，VERIS HCV检测法结果与COBAS Ampliprep/COBAS Taqman HCV检测法（来自13名患者的52份样本）和实时HCV检测法（来自28名患者的112份样本）之间的水平相似。
用于DxN VERIS分子诊断系统的VERIS HCV检测法是一种可靠的新工具，可轻松实现从样本到获得HCV RNA病毒载量监测结果。
