Dickeson David J, Chen Sharon C-A, Sintchenko Vitali G
Centre for Infectious Diseases and Microbiology Laboratory Services, Pathology West - Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, Australia.
Centre for Infectious Diseases and Microbiology Laboratory Services, Pathology West - Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, Australia; Centre for Infectious Diseases and Microbiology - Public Health, Western Sydney Local Health District, Sydney, NSW, Australia.
Pathology. 2016 Apr;48(3):251-6. doi: 10.1016/j.pathol.2016.02.004. Epub 2016 Mar 5.
Serological tests show considerable variation in their ability to correctly diagnose Lyme borreliosis (LB). This study compared four commercially available screening enzyme immunoassays (EIA) for the detection of LB IgG using either whole cell lysate (WCL) antigens, purified proteins or recombinant antigens with the second-tier whole cell sonicate (WCS) western immunoblots or recombinant antigen line blots. A consensus between three EIA results from 222 patient sera was designated as a point of comparison for each method which gave 66 positive and 156 negative results. The positive predictive values (PPV) of WCL EIA were 40% for the MarDx Diagnostics Borrelia burgdorferi EIA 'combined' IgG and IgM (Trinity Biotech) and 55% for the EUROIMMUN plus VlsE IgG. These were significantly lower PPVs than that produced by the recombinant antigen-based EIA NovaLisa Borrelia burgdorferi IgG-ELISA (NovaTec Immunodiagnostica) and the EUROIMMUN Anti-Borrelia Select ELISA IgG (90% and 100%, respectively; p = 0.02). The WCS western immunoblot using B. burgdorferi and B. afzelii separately showed a high PPV of 91% but its positive agreement with consensus EIA result was only 65%. Another WCL western immunoblot with purified extracts of Osp C and VlsE, the Trinity Biotech EU Lyme + VlsE IgG Western Blot had a PPV of 92% while the recombinant line blot from EUROIMMUN, the Anti-Borrelia (IgG) EUROLINE-RN-AT, demonstrated a significantly reduced PPV of 70% with some non-specific reactions in sera containing antibodies to Leptospira species, Helicobacter pylori and Treponema pallidum. The use of recombinant antigens in EIA for LB IgG screening significantly improves the predictive values of serological results above those of WCL antigen EIA. Second tier WCS western immunoblots offer high PPVs, especially with added specific purified proteins, more so than in one recombinant line blot.
血清学检测在正确诊断莱姆病（LB）的能力上存在很大差异。本研究比较了四种市售的用于检测LB IgG的筛查酶免疫测定法（EIA），这些方法分别使用全细胞裂解物（WCL）抗原、纯化蛋白或重组抗原来进行检测，并与二级全细胞超声裂解物（WCS）免疫印迹法或重组抗原线性印迹法进行比较。以222份患者血清的三种EIA结果的共识作为每种方法的比较点，其中有66份阳性结果和156份阴性结果。对于MarDx Diagnostics伯氏疏螺旋体EIA“联合”IgG和IgM（Trinity Biotech），WCL EIA的阳性预测值（PPV）为40%，而EUROIMMUN加VlsE IgG的PPV为55%。这些PPV显著低于基于重组抗原的EIA NovaLisa伯氏疏螺旋体IgG - ELISA（NovaTec Immunodiagnostica）和EUROIMMUN抗伯氏疏螺旋体选择性ELISA IgG的PPV（分别为90%和100%；p = 0.02）。分别使用伯氏疏螺旋体和阿氏疏螺旋体的WCS免疫印迹显示PPV高达91%，但其与共识EIA结果的阳性一致性仅为65%。另一种使用Osp C和VlsE纯化提取物的WCL免疫印迹，即Trinity Biotech欧盟莱姆 + VlsE IgG Western Blot的PPV为92%，而EUROIMMUN的重组线性印迹，抗伯氏疏螺旋体（IgG）EUROLINE - RN - AT显示PPV显著降低至70%，在含有针对钩端螺旋体属、幽门螺杆菌和梅毒螺旋体抗体的血清中有一些非特异性反应。在EIA中使用重组抗原进行LB IgG筛查，与WCL抗原EIA相比，显著提高了血清学结果的预测值。二级WCS免疫印迹提供了高PPV值，特别是添加了特定纯化蛋白时，比一种重组线性印迹表现得更明显。
