Arens Max
Department of Pediatrics, Washington University School of Medicine, St. Louis Children's Hospital, Room 2N-68, St. Louis, MO 63110, USA.
J Clin Virol. 2003 Aug;27(3):235-41. doi: 10.1016/s1386-6532(02)00176-2.
We performed the Roche Amplicor Monitor hepatitis C virus (HCV) v2.0 microwell plate (MWP) assay for 2 years prior to bringing a COBAS instrument into the lab. Before reporting any results from the automated COBAS Amplicor Monitor HCV v2.0, we compared quantitative data with results on the same specimens from the manual Amplicor Monitor HCV.
To determine if the COBAS Amplicor Monitor assay yielded quantitative results that were comparable with those given by the manual Amplicor Monitor HCV.
We tested 145 specimens with both assays. Specimens were chosen on the basis of having fallen within the linear range of the first assay.
The log(10) mean (+/-standard deviation) for all 145 specimens was 5.976 (+/-0.597) for the COBAS and 6.142 (+/-0.597) for the MWP assay. When plotted as 145 pairs of numbers (log MWP result vs. log COBAS result), the linear regression line was displaced slightly downward from the line of equivalence by 0.1 log at the lower end and by 0.2 log at the upper end indicating the COBAS result was somewhat lower than the MWP result across the full range of the assay. The mean of the difference of the manual method and the COBAS for all 145 specimens was 0.166 log(10). A subset of 45 specimens for which we had HCV genotype data was analyzed separately. This set of specimens (of which 33 were genotype 1) also showed excellent concordance between the automated and manual methods. The two trendlines, one for genotype 1 and the other for genotypes 2, 3 and 4, were superimposable and thus the quantitative results were apparently not influenced by the genotypes, although the numbers were small (six HCV genotype 2, five HCV genotype 3 and one HCV genotype 4).
We conclude that the automated Roche COBAS Amplicor Monitor v2.0 yields results that are comparable with the manual Amplicor Monitor assay for HCV genotype 1 and possibly also for genotypes 2, 3 and 4.
在将COBAS仪器引入实验室之前，我们进行了两年的罗氏Amplicor监测丙型肝炎病毒（HCV）v2.0微孔板（MWP）检测。在报告自动COBAS Amplicor监测HCV v2.0的任何结果之前，我们将定量数据与手动Amplicor监测HCV对相同标本的结果进行了比较。
确定COBAS Amplicor监测检测产生的定量结果是否与手动Amplicor监测HCV的结果相当。
我们用两种检测方法对145份标本进行了检测。标本是根据其落在第一种检测方法的线性范围内而选择的。
所有145份标本的log(10)平均值（±标准差），COBAS法为5.976（±0.597），MWP法为6.142（±0.597）。当将其绘制成145对数（log MWP结果与log COBAS结果）时，线性回归线在等效线下方略有偏移，低端偏移0.1 log，高端偏移0.2 log，这表明在整个检测范围内，COBAS结果略低于MWP结果。所有145份标本的手动方法与COBAS法差异的平均值为0.166 log(10)。对我们有HCV基因型数据的45份标本子集进行了单独分析。这组标本（其中33份为基因型1）在自动和手动方法之间也显示出极好的一致性。两条趋势线，一条针对基因型1，另一条针对基因型2、3和4，是可叠加的，因此尽管数量较少（6份HCV基因型2、5份HCV基因型3和1份HCV基因型4），定量结果显然不受基因型的影响。
我们得出结论，自动化的罗氏COBAS Amplicor监测v2.0产生的结果与手动Amplicor监测HCV基因型1的检测结果相当，可能对基因型2、3和4也相当。
