ELISA法检测HIV抗体的影响因素和控制措施

目的酶联免疫吸附实验(ELISA)在基层HIV抗体筛查实验室ELISA法被普遍应用,但又因其存在的诸多干扰因素,对结果的准确性起到了一定的限制,为了消除这些影响因素,检验人员在操作中必须采取相应的控制措施,以利于检验结果的准确可靠。方法依据中国疾病预防控制中心《全国艾滋病检测技术规范》(2009年修订版)的要求,主要从标本因素、试剂因素、温度因素、操作因素等方面着手,来采取相应的控制措施,试剂由北京万泰试剂有限公司(批号为120090101)和珠海丽珠试剂有限公司(批号为20090105)提供。结果珠海丽珠试剂有限公司检测的CV(预期变异)为5.43%,北京万泰试剂有限公司检测的CV(预期变异)为11.92%,《全国艾滋病检测技术规范》要求小于20.00%,合乎要求。通过对标本、试剂、温度、人员技术操作等诸多因素的控制,有效地避免了筛查结果中假阴性或假阳性等偏差的出现。结论对于我们基层的HIV抗体初筛实验室的工作人员来说,消除ELISA法检测HIV抗体操作中各个环节存在的影响因素,扬长避短,对保证检验结果的准确可靠是至关重要的。

ELISA method for the detection of HIV antibodies to the Influencing factors and control measures

Objective Enzyme linked immunosorbent assay(ELISA) is a commonly used solid phase immunoassay method,because of its high sensitivity,strong specificity,low cost and other advantages,are widely used in two on the hepatitis B virus,HIV antibody of Treponema pallidum antibody detection,and so on,especially in the primary HIV antibody screening laboratory ELISA method is widely applied,but because of the many interference factors,on the accuracy of the results has some limitations,in order to eliminate these factors,inspection personnel in operation must take corresponding control measures,in order to facilitate the inspection results are accurate and reliable.Methods According to the Chinese Center for Disease Control and prevention" national HIV testing technical specifications"(2009 Edition) requirements,mainly from the factors of sample,reagent,temperature factors,factors of operation factors and other aspects,to take corresponding control measures,reagent by Thomas Beijing reagent limited company(batch of 120090101) and the Zhuhai Franc(reagent limited company lot number 20090105) provide.Results Zhuhai Franc reagents Limited detection of cv %(expected variability) 5.43 %,Beijing Tai reagents Limited detection of cv %(expected variability) for 11.92 %," National AIDS testing technical norms" requirements of less than 20.00 %,in line with the requirements.Through the specimen,reagent,temperature,personnel and technical operation of many factors such as control,effectively avoids the screening results in false negative or false positive,deviation appears.Conclusion For our primary HIV antibody screening laboratory staff,elimination of ELISA assay for detection of HIV antibody operation of the various links in the influence factors,foster strengths and circumvent weaknesses,to ensure the accuracy and reliability of test results is essential.