摘要
目的评价血液制品生产用原料人血浆病毒核酸检测试剂的适用性。方法常规ELISA法检测合格的18 636份原料血浆样本,分别采用cobas s 201系统的6份和96份样本混合筛查模式进行乙型肝炎病毒(hepatitis B virus,HBV)、丙型肝炎病毒(hepatitis C virus,HCV)、人免疫缺陷病毒(human immunode-ficiency virus,HIV)核酸筛查,对筛查到的反应性样本进行COBAS AmpliPrep/COBAS TaqMan HBV/HCV/HIV-1 test(简称CAP/CTM)核酸鉴别试验,评价不同混合筛查模式在实际检测中的适用性。结果 18 636份血浆样本中,6份样本混合筛查模式检测到12份反应性样本,96份样本混合筛查模式未检出反应性样本。CAP/CTM核酸鉴别试验结果表明,12份反应性样本中有6份检测到低浓度(<20 IU/mL)HBV核酸,未检测到HIV、HCV核酸阳性样本。结论 96份样本混合筛查模式可有效检测到病毒核酸阳性样本,未发生高浓度病毒样本漏检,未检测到的低浓度样本可通过后续病毒灭活工艺进行有效灭活,不影响血液制品的安全性,且该筛查模式的检测通量更大,更适合用于原料血浆的常规核酸检测筛查。
Objective To evaluate the applicability of viral nucleic acid screening reagent for human plasma as a raw material.Methods A total of 18 636 plasma samples qualified in ELISA were tested by mixed screening models of 6 samples and 96 samples in cobas s 201 system separately.The screened positive samples were subjected to COBAS AmpliPrep/COBAS TaqMan HBV/HCV/HIV-1(CAP/CTM) test to evaluate the applicability of the two screening models in practical test.Results Twelve positive samples were screened by mixed screening model of 6 samples,while no positive samples were screened by mixed screening model of 96 samples.HBV nucleic acid at low concentrations(less than 20 IU/mL)were detected in 6 of the 12 samples by CAP/CTM test,while no HIV and HCV nucleic acid positive samples were detected.Conclusion Viral nucleic acid positive samples may be effectively screened by mixed screening model of 96 samples,while no high concentration samples are missed.The undetected low concentration samples may be effectively inactivated by the further virus inactivation procedure,which shows no influence on the safety of blood products.The screening model shows high throughout,which is suitable for the routine nucleic acid screening of plasma as a raw material.
作者
石艳红
邓琨
杨邦玲
李茜
SHI Yan-hong;DENG Kun;YANG Bang-ling;LI Qian(Wuhan Institute of Biological Products .Co.,Ltd.,Wuhan 430207,Hubei Province,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2019年第1期54-56,共3页
Chinese Journal of Biologicals
关键词
血浆
核酸检测
乙型肝炎病毒
丙型肝炎病毒
人类免疫缺陷病毒
Plasma
Nucleic acid testing (NAT)
Hepatitis B virus
Hepatitis C virus
Human immunodeficiency virus
