Evaluation of a p21e-spiked western blot (immunoblot) in confirming human T-cell lymphotropic virus type I or II infection in volunteer blood donors. The Retrovirus Epidemiology Donor Study Group.
Evaluation of a p21e-spiked western blot (immunoblot) in confirming human T-cell lymphotropic virus type I or II infection in volunteer blood donors. The Retrovirus Epidemiology Donor Study Group.
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评估 p21e 蛋白印迹（免疫印迹）在确认志愿者献血者中人类 T 细胞嗜淋巴细胞病毒 I 型或 II 型感染方面的作用。
DOI：
10.1128/jcm.32.3.603-607.1994
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发表时间：
1994
影响因子：
9.4
通讯作者：
Busch,M
中科院分区：
文献类型：
--
作者：
Kleinman,SH;Kaplan,JE;Khabbaz,RF;Calabro,MA;Thomson,R;Busch,M
目前用于人类t细胞嗜淋巴病毒I型和II型（HTLV-I/II）抗体反应性的血清学确认算法是复杂的。我们评估了重组p21e蛋白（p21e WB）加标HTLV-I Western blot（免疫印迹）作为当前验证方法的替代方案的性能。这些方法包括HTLV-I病毒裂解物Western blot和放射免疫沉淀法或p21e酶联免疫吸附法。从美国5个血液中心采集的559例献血者，经常规检测方法分类为HTLV-I/II血清阳性（n = 149）或血清不确定（n = 410），通过PCR检测前病毒DNA和p21e WB进一步评估。经血清学和PCR检测，155例献血者被归为HTLV-I/II型感染。p21e WB的敏感性为97.4%，略高于常规确认性检测。p21e WB的特异性为97.5%，通过检测404个PCR阴性的血清不确定样本确定。p21e WB阳性预测值为94%。常规确认性检测的特异性和阳性预测值均为100%。对假定的p21e WB假阳性供者的随访抽样证实没有HTLV-I/II感染。尽管本研究中使用的p21e WB具有高灵敏度，可能在流行病学研究中作为确证性检测有用，但作为通知献血者的确证性检测可能不理想。
Current algorithms for the serologic confirmation of human T-cell lymphotropic virus type I and II (HTLV-I/II) antibody reactivity are complicated. We evaluated the performance of an HTLV-I Western blot (immunoblot) spiked with recombinant p21e protein (p21e WB) as an alternative to current confirmatory methods. These methods include the HTLV-I viral lysate Western blot and either a radioimmunoprecipitation assay or a p21e enzyme-linked immunosorbent assay. Five hundred fifty nine blood donations obtained from five U.S. blood centers and classified as HTLV-I/II seropositive (n = 149) or seroindeterminate (n = 410) by routine testing methods were further evaluated by PCR for proviral DNA and by the p21e WB. On the basis of serologic and PCR testing, 155 donations were classified as HTLV-I/II infected. The sensitivity of the p21e WB was 97.4%, slightly exceeding that of routine confirmatory testing. The specificity of the p21e WB was 97.5%, as determined by testing of 404 seroindeterminate samples that were negative in the PCR. The positive predictive value of the p21e WB was 94%. In contrast, the specificity and positive predictive value of routine confirmatory testing were both 100%. Follow-up sampling of presumptive p21e WB false-positive donors substantiated the absence of HTLV-I/II infection. Although the p21e WB used in this study has high sensitivity and may be useful as a confirmatory assay in epidemiologic research studies, it may not be ideal as a confirmatory test for the notification of blood donors.