Stelzl Evelyn, Appel Hannah M, Mehta Rochak, Marins Ed G, Berg Jörg, Paar Christian, Zurl Hanna, Santner Brigitte I, Kessler Harald H
Clin Chem Lab Med. 2017 Mar 1;55(4):517-521. doi: 10.1515/cclm-2016-0620.
Determination of the hepatitis C virus (HCV) genotype and discrimination between HCV subtypes 1a and 1b is still mandatory prior to anti-HCV treatment initiation. The aim of this study was to evaluate the performance of the recently introduced cobas® HCV GT assay (Roche) and to compare it to two comparator assays.
The cobas® HCV GT assay is based on primer-specific real-time polymerase chain reaction (PCR). For comparison, the TRUGENE® HCV 5'NC Genotyping Kit (Siemens) and the VERSANT® HCV Genotype 2.0 Assay (Siemens) were employed. Accuracy of the new assay was determined using proficiency panels. For clinical evaluation, 183 residual clinical samples obtained from patients with chronic hepatitis C infection were included.
When accuracy was tested, panel members containing HCV subtypes 1a, 1b, and 3a were identified as expected; however, the new assay failed to identify low titer panel members containing HCV subtype 5a correctly. Of 183 clinical samples, 160 gave concordant results. For seven samples, an indeterminate result was reported with the cobas® HCV GT assay and the remaining 16 samples were found discordant with one of the comparator assays. When time-to-results of the assays were compared, the new assay showed shorter total time and similar hands-on time per sample.
The cobas® HCV GT assay showed a good performance and proved to be suitable for use in the routine diagnostic laboratory. Due to the high level of automation, fast and reliable results are obtained with short hands-on time.
在开始抗丙型肝炎病毒（HCV）治疗之前，确定HCV基因型以及区分HCV 1a和1b亚型仍然是必不可少的。本研究的目的是评估最近推出的cobas® HCV GT检测法（罗氏公司）的性能，并将其与另外两种对照检测法进行比较。
cobas® HCV GT检测法基于引物特异性实时聚合酶链反应（PCR）。为作比较，采用了TRUGENE® HCV 5'NC基因分型试剂盒（西门子公司）和VERSANT® HCV基因型2.0检测法（西门子公司）。使用能力验证样本确定新检测法的准确性。为进行临床评估，纳入了从慢性丙型肝炎感染患者获取的183份残留临床样本。
在测试准确性时，含有HCV 1a、1b和3a亚型的能力验证样本被正确识别；然而，新检测法未能正确识别含有HCV 5a亚型的低滴度能力验证样本。在183份临床样本中，160份结果一致。对于7份样本，cobas® HCV GT检测法报告结果不确定，其余16份样本与其中一种对照检测法结果不一致。在比较各检测法的出结果时间时，新检测法显示总时间更短，且每份样本的实际操作时间相似。
cobas® HCV GT检测法表现良好，证明适用于常规诊断实验室。由于自动化程度高，实际操作时间短，可获得快速可靠的结果。
