Sensitivity and specificity of human T-lymphotropic virus (HTLV) types I and II polymerase chain reaction and several serologic assays in screening a population with a high prevalence of HTLV-II.

Sensitivity and specificity of human T-lymphotropic virus (HTLV) types I and II polymerase chain reaction and several serologic assays in screening a population with a high prevalence of HTLV-II.
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人类 T 淋巴细胞病毒 (HTLV) I 型和 II 型聚合酶链反应以及多种血清学检测在筛查 HTLV-II 高患病率人群中的敏感性和特异性。

DOI:
10.1046/j.1537-2995.1999.39111185.x
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发表时间:
1999
期刊:
影响因子:
2.9
通讯作者:
Murphy,EL
Murphy,EL
中科院分区:
医学3区
文献类型:
--
作者:
Liu,H;Shah,M;Stramer,SL;Chen,W;Weiblen,BJ;Murphy,EL

文献摘要

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背景:自1988年以来,美国所有献血都进行了人类T淋巴细胞病毒I型(HTLV-I)抗体筛查。然而,目前的HTLV II型(HTLV-II)抗体检测的血清学试验的灵敏度和HTLV-I和-II使用聚合酶链反应(PCR)的直接测试的诊断效用是不明确的defined.Study设计和方法:五百六十九HTLV-I-或-II-血清阳性和687年龄和性别匹配的血清阴性样本从一个高风险人群在内城急诊科被选中。所有样本均采用四种HTLV酶免疫测定法(EIA)、一种Western blot测定法和一种类型特异性Western blot测定法、一种HTLV类型特异性EIA和一种研究HTLV‐I/II PCR试剂盒进行检测。重复PCR检测而不进行选择性复检,敏感性(85.1%)和特异性(88.0%)较低。然而,在所有EIA均为阴性的627份样本中,PCR检测到20份(3.2%)HTLV‐I阳性和47份(7.5%)HTLV‐II阳性样本。类型特异性EIA和PCR检测在将样本分类为HTLV-I或-II时具有最高的一致率,类型特异性EIA和类型特异性Western blot具有次高的一致率。结论:在来自HTLV-II高危人群的样本集中,HTLV-I/II PCR筛查的敏感性和特异性低于EIA。然而,4.1%至10.8%的样本为PCR阳性,但HTLV-I或-II为血清阴性,其真实感染状态尚未确定。
BACKGROUND:Since 1988, all blood donations in the United States have been screened for antibodies to human T‐lymphotropic virus type I (HTLV‐I). However, the sensitivity of current serologic tests for the detection of HTLV type II (HTLV‐II) antibodies and the diagnostic utility of direct tests for HTLV‐I and ‐II using polymerase chain reaction (PCR) are poorly defined.STUDY DESIGN AND METHODS:Five hundred sixty‐nine HTLV‐I‐ or ‐II‐seropositive and 687 age‐ and sex‐matched seronegative samples from a high‐risk population at an inner‐city emergency department were selected. All samples were tested with four HTLV enzyme immunoassays (EIAs), one Western blot assay and one type‐specific Western blot assay, one HTLV type‐specific EIA, and a research HTLV‐I/II PCR kit.RESULTS:Sensitivity of the various EIAs ranged from 95.1 to 99.5 percent, and specificity ranged from 97.2 to 99.4 percent. PCR performed in duplicate without selective retesting had lower sensitivity (85.1%) and specificity (88.0%). However, PCR detected 20 (3.2%) HTLV‐I‐positive and 47 (7.5%) HTLV‐II‐positive samples among the 627 samples that were negative in all EIAs. The type‐specific EIA and PCR assay had the highest rate of concordance in classifying samples as either HTLV‐I or ‐II, with the type‐specific EIA and type‐specific Western blot having the next highest rates of concordance.CONCLUSION:In this sample set from a population at high risk for HTLV‐II, screening with HTLV‐I/II PCR had lower sensitivity and specificity than that with EIAs. However, 4.1 to 10.8 percent of samples were PCR positive but seronegative for HTLV‐I or –II, and their true infection status remains undetermined.