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逆转录聚合酶链反应法检测丙型肝炎病毒核糖核酸的临床评估——特别提及Amplicor HCV检测试剂盒

[Clinical evaluation of RT-PCR method for detection of HCV-RNA--with special reference to Amplicor HCV].

作者信息

Furuwatari C, Suzuki K, Matsumoto A, Kobayashi M, Kiyosawa K, Hidaka E, Ueno I, Ogiso Y, Furihata K, Katsuyama T

机构信息

Central Clinical Laboratories, Shinshu University Hospital, Matsumoto.

出版信息

Rinsho Byori. 1997 Aug;45(8):790-4.

PMID:9283232
Abstract

Detection of the viral genome in serum is the most reliable way to analyze HCV viremia. In the present study, we evaluated the availability of a new detection kit for HCV-RNA, Amplicor HCV, which is based on the RT-PCR microplate hybridization protocol. The procedure of Amplicor HCV is simple, unlike the conventional RT-nested-PCR method. Although Amplicor HCV assay exhibited the lower sensitivity than the the conventional RT-nested-PCR method (10 x for HCV type 1a, 1b and 2b; 10(3) x for type 2a), Amplicor HCV assay could detect the HCV-RNA in all HCV-RNA positive cases by conventional RT-nested PCR method, except for one case who contained low concentration of HCV-RNA (10 copies/ml). The coincidence rate was 99.2% in 120 clinical samples between two assays. Amplicor HCV assay, moreover, could efficiently evaluate the viremia regardless of anti-HCV-2 antibody titer. This assay was useful for monitoring the effect of interferon therapy during and after administration. These results suggest that Amplicor HCV has an excellent availability for the clinical laboratories.

摘要

血清中病毒基因组的检测是分析丙型肝炎病毒血症最可靠的方法。在本研究中,我们评估了一种基于逆转录-聚合酶链反应微孔板杂交技术的新型丙型肝炎病毒核糖核酸(HCV-RNA)检测试剂盒——Amplicor HCV的实用性。与传统的逆转录巢式聚合酶链反应方法不同,Amplicor HCV的操作过程简单。尽管Amplicor HCV检测法的灵敏度低于传统的逆转录巢式聚合酶链反应方法(1型a、1b和2b型丙型肝炎病毒为10倍;2a型为10³倍),但除了1例丙型肝炎病毒核糖核酸浓度较低(10拷贝/毫升)的病例外,Amplicor HCV检测法能够检测出所有经传统逆转录巢式聚合酶链反应方法检测为丙型肝炎病毒核糖核酸阳性的病例。两种检测方法对120份临床样本的符合率为99.2%。此外,无论抗-HCV-2抗体滴度如何,Amplicor HCV检测法都能够有效地评估病毒血症。该检测法有助于监测干扰素治疗在给药期间及之后的效果。这些结果表明,Amplicor HCV对临床实验室具有出色的实用性。

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