Fransen K, van Kerckhoven I, Piot P, van der Groen G
Institute of Tropical Medicine, Department Infection and Immunity, Division of Microbiology, Nationalestraat 155, 2000 Antwerpen, Belgium.
Clin Diagn Virol. 1995 Dec;4(4):311-9. doi: 10.1016/0928-0197(95)00016-x.
The polymerase chain reaction (PCR), a powerful gene amplification technique, is moving rapidly from the research laboratory into routine clinical use.
To evaluate the specificity and sensitivity of a commercially available PCR kit, the Amplicor HIV-1 PCR kit (AMP) and to compare it with an in-house nested PCR, which amplified part of the POL gene (POL(n)).
A total of 517 samples were tested by AMP, including 159 fresh whole blood specimens from HIV-1 antibody positive Europeans and 358 archival samples (338 seropositive and 20 seronegative individuals) originating from 35 different countries in Africa and Europe. We compared the performance of AMP on the archival samples with POL(n).
The overall sensitivity and specificity as compared to HIV-1 serology were 93% and 100%, and 96% and 100%, for AMP and the in-house PCR, respectively. Repeat testing on co-cultured lymphocytes increased the sensitivity of AMP to 95%.
AMP is a rapid, and easy to use commercially available PCR kit, since only one amplification of the test sample is required. Moreover, the use of radioactivity is omitted, and reading of the test can be done with a spectrophotometer. The use of at least one additional primer pair may increase confidence in distinguishing a positive and negative sample by both PCR techniques.
聚合酶链反应（PCR）是一种强大的基因扩增技术，正迅速从研究实验室进入临床常规应用。
评估市售的Amplicor HIV-1 PCR试剂盒（AMP）的特异性和敏感性，并将其与扩增POL基因部分片段的自制巢式PCR（POL(n)）进行比较。
共对517份样本进行了AMP检测，其中包括159份来自HIV-1抗体阳性欧洲人的新鲜全血标本，以及358份存档样本（338份血清学阳性和20份血清学阴性个体）来自非洲和欧洲的35个不同国家。我们将AMP在存档样本上的性能与POL(n)进行了比较。
与HIV-1血清学相比，AMP和自制PCR的总体敏感性和特异性分别为93%和100%，以及96%和100%。对共培养淋巴细胞进行重复检测可将AMP的敏感性提高到95%。
AMP是一种快速且易于使用的市售PCR试剂盒，因为对测试样本仅需进行一次扩增。此外，无需使用放射性物质，并且可以用分光光度计读取测试结果。使用至少一对额外的引物对可能会增加两种PCR技术区分阳性和阴性样本的可信度。
