Highbarger Helene C, Hu Zonghui, Kottilil Shyam, Metcalf Julia A, Polis Michael A, Vasudevachari M B, Lane H Clifford, Dewar Robin L
Virus Isolation and Serology Laboratory, SAIC--Frederick, Inc., NCI--Frederick, Frederick, MD 21702, USA.
J Clin Microbiol. 2007 Sep;45(9):2808-12. doi: 10.1128/JCM.00202-07. Epub 2007 Jun 27.
This study compared two commercially available assays for the measurement of hepatitis C virus (HCV) RNA levels, the Bayer HCV RNA (version 3.0) branched DNA assay and the Abbott HCV analyte-specific reagent real-time PCR assay, to assess their quantitative relationships, ease of performance, and time to completion. The study group consisted of randomly selected patients from the NIAID human immunodeficiency virus (HIV) outpatient clinic who were infected with HIV type 1 and HCV. One hundred eighty-four samples from 66 patients coinfected with HIV and HCV receiving treatments under various protocols were analyzed for the correlation and agreement of the results. The results indicated that the two assays correlate well in the overlapping linear ranges of the assays and show good agreement. From the results obtained, we have derived a mathematical formula to compare the viral load results between the two assays, which is given as log(10) Abbott assay measure = 0.032 + 1.01 log(10) Bayer assay measure. Although it is preferable to use the same quantitation assay throughout the course of a patient's treatment, valid comparisons of the HCV RNA levels may be made between the results obtained by either of these assays in the overlapping linear range (615 to 7,700,000 IU/ml).
本研究比较了两种用于测量丙型肝炎病毒（HCV）RNA水平的市售检测方法，即拜耳HCV RNA（3.0版）分支DNA检测法和雅培HCV分析物特异性试剂实时PCR检测法，以评估它们的定量关系、操作简便性和完成时间。研究组由从美国国立过敏与传染病研究所（NIAID）人类免疫缺陷病毒（HIV）门诊随机选取的感染1型HIV和HCV的患者组成。对66例同时感染HIV和HCV且正在接受各种方案治疗的患者的184份样本进行了分析，以研究结果的相关性和一致性。结果表明，两种检测方法在检测的重叠线性范围内相关性良好，一致性也较好。根据所得结果，我们推导出了一个数学公式来比较两种检测方法之间的病毒载量结果，即log(10)雅培检测法测量值 = 0.032 + 1.01 log(10)拜耳检测法测量值。虽然在患者整个治疗过程中最好使用同一定量检测方法，但在重叠线性范围（615至7,700,000 IU/ml）内，这两种检测方法所获得的结果之间可以对HCV RNA水平进行有效的比较。
