Two-Tiered Antibody Testing for Lyme Disease With Use of 2 Enzyme Immunoassays, a Whole-Cell Sonicate Enzyme Immunoassay Followed by a VlsE C6 Peptide Enzyme Immunoassay
Two-Tiered Antibody Testing for Lyme Disease With Use of 2 Enzyme Immunoassays, a Whole-Cell Sonicate Enzyme Immunoassay Followed by a VlsE C6 Peptide Enzyme Immunoassay
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DOI：
10.1093/cid/cir464
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发表时间：
2011-09-15
影响因子：
11.8
通讯作者：
Ferraro, Mary Jane
中科院分区：
文献类型：
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作者：
Branda, John A.;Linskey, Katy;Ferraro, Mary Jane
背景莱姆病（LD）抗体检测目前涉及两层算法与全细胞超声（WCS）酶免疫测定（EIA），其次是IgM/IgG蛋白质免疫印迹。使用伯氏疏螺旋体可变主要蛋白样序列表达的脂蛋白的C6肽的单一EIA提供与标准2层测试相比相似或更好的灵敏度，但特异性较低。在这里，我们研究了一种替代的2层策略，其中第一步仍然是WCS EIA，但免疫印迹被C6 EIA取代。我们使用来自研究性LD患者的91份血清样本和来自LD患者的78份血清样本（样本提交给我院临床实验室）确定了3种检测策略的灵敏度。使用54例其他疾病患者和1246名健康受试者的地方性和非地方性感染的地区进行特异性测定。早期LD的2-EIA算法与单独的C6测试具有相似的灵敏度，两种策略的灵敏度均优于标准2层测试（分别为61%和64% vs 48%; P = 0.03和P = 0.008）。对于晚期疾病，所有3种策略均具有100%的敏感性。2-EIA算法的特异性与标准2层检测的特异性相同，两种2层策略的特异性均高于单独的C6检测（两者均为99.5% vs 98.4%; P = 0.01）。2-EIA算法的阳性预测值为70%，而标准2层检测为66%，单独C6 EIA为43%。2-EIA策略匹配C6 EIA和Western印迹的个体优势，而没有缺点。2种EIA提供的灵敏度与C6 EIA相当，但保持了标准2级检测的特异性。
Background. Lyme disease (LD) antibody testing currently involves a 2-tiered algorithm with a whole-cell sonicate (WCS) enzyme immunoassay (EIA), followed by IgM/IgG Western immunoblots. A single EIA using the C6 peptide of the Borrelia burgdorferi variable-major protein-like sequence expressed lipoprotein provides similar or better sensitivity but less specificity, compared with standard 2-tiered testing. Here, we investigated an alternative 2-tiered strategy, in which the first step remained a WCS EIA, but immunoblotting was replaced by a C6 EIA.Methods. We determined the sensitivity of the 3 testing strategies with use of 91 serum samples from research study patients with LD and 78 serum samples from patients with LD whose samples were submitted to our hospital's clinical laboratory. Specificity was measured using 54 patients with other illnesses and 1246 healthy subjects from areas where the infection is endemic and nonendemic.Results. The 2-EIA algorithm in early LD had similar sensitivity as C6 testing alone, and both strategies had better sensitivity than did standard 2-tiered testing (61% and 64%, respectively, vs 48%; P = .03 and P = .008). For late disease, all 3 strategies had 100% sensitivity. The specificity of the 2-EIA algorithm was equal to that of standard 2-tiered testing, and both 2-tiered strategies were more specific than C6 testing alone (for both, 99.5% vs 98.4%; P = .01). The positive predictive value of the 2-EIA algorithm was 70%, compared with 66% for standard 2-tiered testing and 43% for the C6 EIA alone.Conclusions. The 2-EIA strategy matched the individual strengths of the C6 EIA and Western blotting, without the drawbacks. The 2 EIAs provided sensitivity comparable to that of the C6 EIA but maintained the specificity of standard 2-tiered testing.