Chris Maple P A, Gunn Annabel, Sellwood Jane, Brown David W G, Gray Jim J
Virus Reference Department, Health Protection Agency Centre for Infections, Colindale, London NW9 5HT, UK.
J Virol Methods. 2009 Feb;155(2):143-9. doi: 10.1016/j.jviromet.2008.09.032. Epub 2008 Nov 28.
The performance of fifteen, commercially available, VZV IgG assays and an "in house" indirect immunofluorescence (IF) assay has been compared to a reference VZV IgG time resolved immunofluorescence assay (VZV TRFIA). A panel of 273 VZV TRFIA IgG positive serum samples and 136 VZV TRFIA IgG susceptible sera, collected from a number of UK hospitals was used. Irrespective of the interpretation of equivocal results the most sensitive assays were Dade Behring EIA (97.4%), "in house" IF (95.2%), Human EIA (92.3%) and Becton Dickinson latex agglutination (94.1%). The least sensitive assays were Virion EIA (69.6%), Diesse EIA (68.9%) and Diasys EIA (68.5%). The least sensitive (<70%) assays all had >99.0% specificity whereas the most sensitive assays had lower specificities; for example, Dade Behring EIA had a specificity of 69.9% when equivocals were treated as VZV IgG negative. For some assays e.g. Dade Behring EIA there were major discrepancies between our findings and those reported by the manufacturer which may reflect the constitution of the panel(s) of sera used for evaluation or the reference method adopted or the choice of cut-off criteria (particularly relevant to our findings for the Behring EIA). Care must be taken to choose an assay with high specificity in order to accurately assess the need for vaccination or immunoprophylaxis; however, high sensitivity is preferable to prevent inappropriate and expensive treatment.
将15种市售的水痘带状疱疹病毒(VZV)IgG检测方法和一种“内部”间接免疫荧光(IF)检测方法与参考VZV IgG时间分辨免疫荧光检测方法(VZV TRFIA)进行了比较。使用了从英国多家医院收集的一组273份VZV TRFIA IgG阳性血清样本和136份VZV TRFIA IgG易感血清。无论对可疑结果如何解读,最敏感的检测方法是达德拜耳酶免疫分析(EIA)(97.4%)、“内部”IF(95.2%)、人类EIA(92.3%)和贝克曼库尔特乳胶凝集试验(94.1%)。最不敏感的检测方法是病毒粒子EIA(69.6%)、迪塞EIA(68.9%)和迪亚Sys EIA(68.5%)。最不敏感(<70%)的检测方法特异性均>99.0%,而最敏感的检测方法特异性较低;例如,当将可疑结果视为VZV IgG阴性时,达德拜耳EIA的特异性为69.9%。对于某些检测方法,如达德拜耳EIA,我们的研究结果与制造商报告的结果存在重大差异,这可能反映了用于评估的血清样本组的构成、采用的参考方法或临界值标准的选择(这与我们对拜耳EIA的研究结果特别相关)。必须谨慎选择具有高特异性的检测方法,以便准确评估疫苗接种或免疫预防的必要性;然而,高灵敏度更可取,以防止不适当和昂贵的治疗。