Failure of human immunodeficiency virus enzyme immunoassay to rule out infection among polymerase chain reaction-negative Vietnamese infants at 12 months of age.
Failure of human immunodeficiency virus enzyme immunoassay to rule out infection among polymerase chain reaction-negative Vietnamese infants at 12 months of age.
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DOI：
10.1097/inf.0b013e31818e03b4
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发表时间：
2009-04
期刊：
影响因子：
--
通讯作者：
Lien TX
中科院分区：
文献类型：
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作者：
Sohn AH;Thanh TC;Thinh le Q;Khanh TH;Thu HK;Giang le T;Lien TX
背景：以前的研究表明，> 90%的未感染艾滋病毒的婴儿在12个月大时血清逆转，如酶免疫测定（EIA）检测结果所示，这使得确认或排除感染是可行的。我们评估了EIA的可靠性在一个队列的Vietnamesinfants.Methods：HIV暴露，未感染的婴儿参加了父母的诊断和监测研究，从2005年2月至2006年8月有资格列入前瞻性队列研究的HIV-EIA性能。使用2种标准检测试剂盒（Genscreen HIV 1/2版本2，Bio-Rad; Murex 1.2. 0，Murex Biotech）在12月龄时开始。婴儿被归类为EIA阴性（血清逆转;阴性Genscreen），EIA不确定（阳性Genscreen，阴性Murex），或EIA阳性（Genscreen和Murex阳性）。结果：纳入研究的273名婴儿中，59名（22%）在12个月时为EIA阴性，131名（48%）为不确定，83名（30%）为EIA阳性;特异性21.6（95%置信区间：16.6，26.3）。婴儿在12个月的EIA阳性74%以上的可能性比EIA不确定的婴儿测试不确定或阳性在18个月（风险比，1.74，95%置信区间：1.15，2.64; P= 0.03）。结论：标准EIA对婴儿血清逆转的预期应重新评估，以反映其性能的潜在跨区域差异。
Background:Previous studies have demonstrated that> 90% of HIV-uninfected infants serorevert, as seen in the results of enzyme immunoassay (EIA) testing by 12 months of age, making it feasible to confirm or rule out infection. We assessed the reliability of EIA in a cohort of Vietnamese infants.Methods:HIV-exposed, uninfected infants enrolled in a parent diagnostic and monitoring study from February 2005 through August 2006 were eligible for inclusion in a prospective cohort study of HIV-EIA performance. Testing using 2 standard assays (Genscreen HIV 1/2 version 2, Bio-Rad; Murex 1.2. 0, Murex Biotech) was initiated at 12 months of age. Infants were categorized as EIA-negative (seroreverted; negative Genscreen), EIA-indeterminate (positive Genscreen, negative Murex), or EIA-positive (Genscreen and Murex positive).Results:Of 273 infants included in the study, 59 (22%) were EIA-negative at 12 months, 131 (48%) were indeterminate, and 83 (30%) were EIA-positive; specificity 21.6 (95% confidence interval: 16.6, 26.3). Infants with positive EIAs at 12 months were 74% more likely than EIA-indeterminate infants to test indeterminate or positive at 18 months (risk ratio, 1.74, 95% confidence interval: 1.15, 2.64; P= 0.03).Conclusions:Expectations regarding infant seroreversion by standard EIAs should be reassessed to reflect potential cross-regional differences in their performance.