Gallo D, Yeh E T, Moore E S, Hanson C V
Viral and Rickettsial Disease Laboratory, State of California Department of Health Services, Berkeley 94704, USA.
J Clin Microbiol. 1996 Jan;34(1):213-5. doi: 10.1128/jcm.34.1.213-215.1996.
Four licensed enzyme immunoassay (EIA) kits for the measurement of antibody to human T-cell lymphotropic virus (HTLV) type 1, one from Organon Teknika Corp. (OTC), one from Cambridge Biotech Corp. (CBC), and two from Abbott Laboratories (the 1993 modification [Abb 93] and the 2.0 version licensed in 1995 [Abb 95]), were evaluated for sensitivity and specificity in the detection of HTLV type 2 antibody, and the results were compared with those previously obtained with earlier kit versions. The CBC, Abb 95, Abb 93, and OTC kits had sensitivities of 99.7, 97.6, 96.8, and 96.2%, respectively, compared with sensitivities of 89.1 and 60% for the Abbott and CBC (previously DuPont) kits, respectively, licensed in 1988. Thus, the abilities of commercial kits to detect HTLV antibody have improved. The relative specificities of the CBC, Abb 95, Abb 93, and OTC kits with negative blood donor specimens that had been reactive with the 1988 CBC EIA kit were 92.9, 64.5, 78.8, and 62.6%, respectively. Compared with those of the 1988 versions, the specificity of the Abbott EIA has decreased and the specificity of the CBC kit has been significantly improved.
对用于检测人类嗜T淋巴细胞病毒1型(HTLV-1)抗体的四种获得许可的酶免疫测定(EIA)试剂盒进行了评估,其中一种来自Organon Teknika公司(OTC),一种来自剑桥生物技术公司(CBC),两种来自雅培实验室(1993年改进版[Abb 93]和1995年获得许可的2.0版[Abb 95]),评估其在检测HTLV-2抗体方面的敏感性和特异性,并将结果与先前使用早期试剂盒版本获得的结果进行比较。CBC试剂盒、Abb 95试剂盒、Abb 93试剂盒和OTC试剂盒的敏感性分别为99.7%、97.6%、96.8%和96.2%,相比之下,1988年获得许可的雅培试剂盒和CBC(先前的杜邦)试剂盒的敏感性分别为89.1%和60%。因此,商用试剂盒检测HTLV抗体的能力有所提高。CBC试剂盒、Abb 95试剂盒、Abb 93试剂盒和OTC试剂盒对与1988年CBC EIA试剂盒呈反应性的阴性献血者标本的相对特异性分别为92.9%、64.5%、78.8%和62.6%。与1988年版本相比,雅培EIA的特异性降低,而CBC试剂盒的特异性显著提高。