用标准HTLV-1血清组评估商用HTLV-1检测试剂盒。
Evaluation of commercial HTLV-1 test kits by a standard HTLV-1 serum panel.
作者信息
Fujiyama C, Fujiyoshi T, Matsumoto D, Tamashiro H, Sonoda S
机构信息
Department of Virology, Faculty of Medicine, Kagoshima University, Japan.
出版信息
Bull World Health Organ. 1995;73(4):515-21.
To evaluate the performance of currently available test kits for human T-cell lymphotropic virus type 1 (HTLV-1), we examined two particle agglutination (PA) tests and nine enzyme immunoassays (EIA) using a standard serum panel consisting of HTLV-1-positive and HTLV-1-negative sera that had been characterized by immunofluorescence and the polymerase chain reaction (PCR). The PA kits exhibited 94.0-100.0% sensitivity and 99.5-100.0% specificity; the sensitivity range was ascribed to the quality of the HTLV-1 antigens coated on the particles. The EIA kits had 99.5-100% sensitivity and 98.5-100% specificity; the 98.5%-99.5% specificity exhibited by five of the EIA kits could have been due to nonspecific reactions that were detected through use of an inadequate cut-off value and the use of recombinant proteins. It can be concluded that the sensitivity of the currently available PA and EIA kits is sufficient to permit their use for screening purposes; however, the specificity of some EIA kits should be optimized.
为评估目前可用的人类嗜T淋巴细胞病毒1型（HTLV-1）检测试剂盒的性能，我们使用了一组标准血清进行检测，该血清组由经免疫荧光和聚合酶链反应（PCR）鉴定的HTLV-1阳性和HTLV-1阴性血清组成，检测了两种颗粒凝集（PA）试验和九种酶免疫测定（EIA）。PA试剂盒的灵敏度为94.0%-100.0%，特异性为99.5%-100.0%；灵敏度范围归因于包被在颗粒上的HTLV-1抗原的质量。EIA试剂盒的灵敏度为99.5%-100%，特异性为98.5%-100%；五种EIA试剂盒显示的98.5%-99.5%的特异性可能是由于使用了不适当的临界值和重组蛋白而检测到的非特异性反应。可以得出结论，目前可用的PA和EIA试剂盒的灵敏度足以用于筛查目的；然而，一些EIA试剂盒的特异性应予以优化。
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