摘要
目的建立抗HBV(乙型肝炎病毒hepatitis B virus)试剂参考品以用于评价血站系统使用的抗HBV试剂盒批检的鉴定。方法收集无偿献血抗HBV阳性标本和阴性标本各100份,对其进行中和实验检测,并结合核酸检测结果。制成血浆参考盘的阴性、阳性及精密度、灵敏度参考品,其中灵敏度参考品是通过将阳性血浆倍比稀释并结合中和实验确证获得。以上样品组成本室抗HBV参考品,并对上述制备而得的参考品用四种试剂进行酶免实验验证,和国家标准参考品进行比对。结果上述参考品由20份阳性、20份阴性、4份灵敏度和1份精密度参考品组成。用四种试剂经ELISA检测后与国家参考品进行比对,符合率为100%。结论本套参考品与国家参考品酶免实验符合度高,稳定性好。灵敏度检测结果适宜本实验室应用。
Objective To establish Anti - HBV reagent reference for evaluation of blood system using anti - HBV kit batch inspection identification. Methods We collecting unpaid blood donation anti - HBV positive samples and negative specimens each are 100 copies, and than take neutralization assay, and combine with nucleic acid testing results The plasma reference disk, positive and negative reference, precision reference, and sensitivity reference are made. Precision reference is made with positive plasma dilution and experimental confirmation for neutralization. We checking the references with four kinds of reagent, and compare them with the national standard reference. Results The references are made up of 20 positive, 20 negative, 4 sensitivity and 1 precision reference. The coincidence rate of these four kinds of reagent is 100% after ELISA detection. Conclusion This reference product has high conformity degree with national reference product, and it is stability. Sensitivity test results are suitable for the laboratory application.
出处
《中国病案》
2013年第3期78-79,共2页
Chinese Medical Record
关键词
中和试验
标准参考品
灵敏度
精密度
Neutralization test
Standard reference
Sensitivity
Precision
