四种商品化单纯疱疹病毒2型特异性IgG抗体检测试剂盒的比较

Comparison of Four Commercially Available ELISA Kits for Detecting HSV-2 Type-specific IgG Antibodies

目的比较4种商品化单纯疱疹病毒(HSV2)型特异IgG抗体检测试剂盒。方法125份血清分别取自生殖器溃疡患者及无性传播疾病史的正常人。选择4种商品化HSV2型特异性IgG抗体检测试剂盒。ELISA方法严格按照试剂盒说明进行。结果以蛋白印迹方法的结果为金标准,国产1、国产2、进口1和进口2共4种试剂盒敏感性和特异性分别为13.1%和98.4%,7.5%和100%,100%和11.1%,87.7%和96.7%;国产1、进口1和进口2三个试剂盒的ROC曲线下面积分别为0.885(0.822～0.948),0.852(0.747～0.902),0.947(0.950～0.998)。结论进口2试剂盒结果与蛋白印迹结果的一致性最好,而其它3种试剂盒则与蛋白印迹结果的一致性很差。本实验结果表明在选择这类产品之前有必要重新评估其可靠性。

Objective To compare the validity of four commercially available ELISA kits for detecting HSV-2 type-specific IgG antibodies. Methods A total of 125 serum specimens were collected from 105 patients with genital ulcers and 20 normal individuals without history of STDs. Four ELISA kits which are commercially available in China for the detection of HSV-2 type-specific IgG antibodies were selected for the evaluation. Western blot assay was used as the gold standard. Results Based on the results of detection by Western blot assay, the sensitivity and specificity of these ELISA kits including home-made 1, home-made 2, improted 1 and improted 2 were 13.1% and 98.4%, 7.5% and 100%, 100% and 11.1%, 87.7% and 96.7%, respectively. The areas under the ROC curve of three kits including home-made 1, imported 1 and imported 2 were 0.885 (0.822 - 0.948), 0.852 (0.747 - 0.902), 0.947 (0.950 - 0.998), respectively. Conclusions The results of imported 2 are well consistent with those of Western blot, while the results of other 3 kits are poorly consistent with those of Western blot. It is also indicated that the commercially available ELISA kits for detecting HSV-2 type-specific antibodies should be re-evaluated in terms of their validity befor being applied for the clinical diagnosis as well as laboratory research.