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方法研究

五厂家EB病毒抗体检测试剂盒血清学诊断鼻咽癌的比较

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  • 1.中国食品药品检定研究院体外诊断试剂2室,北京 100050; 2.卫生部生物技术产品检定方法及其标准化重点实验室,北京 100050; 3.广东省中山市肿瘤研究所,广东 中山 528403; 4.北京北方生物技术研究所,北京100076
石大伟,博士,助理研究员。研究方向:诊断试剂质量评价和标准化研究。Tel:010-67095776; E-mail:davidstone340@163.com

收稿日期: 2014-03-06

  修回日期: 2014-05-08

  网络出版日期: 2014-07-15

基金资助

中国食品药品检定研究院中青年发展研究基金课题(EB病毒基因多态性及其对诊断试剂性能的影响,编号:2012B12);国家高技术研究发展计划(863计划)新型体外诊断试剂质量评价体系和国家参考物质研究(项目编号2011AA02A115)

valuation of Commercial Kits of Detecting EBV Antibodies for Nasopharyngeal Carcinoma Diagnosis

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  • The 2nd Department of In Vitro Diagnostic Products, National Institutes for Food and Drug Control, Beijing 100050, China

Received date: 2014-03-06

  Revised date: 2014-05-08

  Online published: 2014-07-15

摘要

目的 通过比较EB病毒抗体检测试剂盒血清学诊断鼻咽癌的准确性和检测结果的一致性,为试剂盒在临床上的使用选择和性能改进提供依据。方法 使用5厂家的EB病毒衣壳抗原IgA和IgG抗体检测试剂盒(VCA IgA和VCA IgG试剂盒)、核抗原1 IgA和IgG抗体检测试剂盒(EBNA1 IgA和EBNA1 IgG试剂盒)、早期抗原IgA和IgG抗体检测试剂盒(EA IgA和EA IgG试剂盒)以及Zta IgA抗体检测试剂盒,分别检测33例鼻咽癌患者(NPC)、30例健康体检者(HD)和41例非鼻咽癌的其他肿瘤患者(NNPC)血清或血浆样本。结果 A厂家的VCA IgA试剂盒灵敏度高于其他厂家同品种试剂盒,但对于NNPC特异度最低(36.6%);而D厂家VCA IgA试剂盒的特异度最高(97.6%),且对HD的特异度均大于90%。B和D厂家的EBNA1 IgA试剂盒间阳性、阴性符合率分别为92.1%和100.0%。A和E厂家的EA IgA试剂盒的灵敏度均较低而特异度高,试剂盒间阳性符合率低(39.4%),阴性符合率高(98.6%);而VCA IgG试剂盒的灵敏度高但特异度低。A和C厂家的EBNA1 IgG试剂盒的灵敏度高(100.0%,97.0%)但特异度低(3.3%,13.3%)。C厂家EA IgG试剂盒检测所有样本结果均为阴性。结论 5个不同厂家VCA IgA、EA IgA试剂盒诊断鼻咽癌的准确性和检测结果的一致性存在差异,特别是A厂家和其他国内厂家同品种试剂间差异明显,需根据临床目的进行选择。3家国产VCA IgA试剂盒的灵敏度需进一步提高。相反,EBNA IgA试剂盒诊断鼻咽癌的准确性和结果一致性较好。单独使用VCA IgG和EBNA1 IgG试剂盒血清学诊断鼻咽癌的特异度差,其判读界值可能需根据检测目的进行调整。

关键词: EB病毒; VCA; EBNA1; EA; 鼻咽癌

本文引用格式

石大伟1,2,王盼盼3,季明芳3,李玉彬4,周海卫1,2,沈 舒1,2,张春涛1,2* . 五厂家EB病毒抗体检测试剂盒血清学诊断鼻咽癌的比较[J]. 标记免疫分析与临床, 2014 , 21(3) : 310 . DOI: 10.11748/bjmy.issn.10061703.2014.03.028

Abstract

Objective To provide substantial data for the choosing of nasopharyngeal carcinoma (NPC) serum diagnostic assays and the quality improvement of commercial kits detecting EBV antibodies. Methods Serum or plasma samples from 33 NPC patients, 30 health donors and 41 non-NPC cancer patients (NNPC) were detected by the commercial kits from 5 different companies for VCA IgA/IgG, EBNA1 IgA/IgG, EA IgA/IgG and Zta IgA detection. Results The specificities of different VCA IgA kits were all high, while the sensitivities were diverse. The sensitivity of the manufacturer A was the highest and the positive agreement rate between the manufacturer A and others was equally low, however the specificity of the manufacturer A was lowest (36.6%) and the manufacturer D ranked first for NNPC. The positive and negative agreements rates between two EBNA1 IgA kits were both high, which were 92.1% and 100% respectively. The sensitivities of EBNA1 IgA kits of the manufacturer B and the manufacturer D were 90.9% and 87.9% each, and the specificities were 96.7% for HD, while 82.9%vand 87.8% for NNPC. The sensitivities of EA IgA were relative low (57.6% for manufacturer A, and 30.3% for manufacturer E) with low positive agreement rate between two kits (39.4%) but the specificities were high (100.0% for manufacturer A and 96.7% for manufacturer E). The sensitivities of VCA IgG of manufacturer A and manufacturer C were 100.0% and 97.0%, and the ones of EBNA1 IgG were similar, but the specificities were quite low except EBNA1 IgG of manufacturer B. Conclusion The differences of diagnostic accuracy and agreement rate between various commercial kits detecting serum or plasma VCA IgA or EA IgA, especially for the manufacturer A and the local products, but not for EBNA1 IgA kits. Three local VCA IgA detection kit showed similar positive results and their sensitivities could be improved further. The proportions of positive results reported by VCA IgG and EBNA1 IgG kits were too high that the cutoff of these products might be modified if using for NPC diagnosis solely.
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