核酸扩增技术在广州市献血员血液筛查中的应用价值

Evaluation of Nucleic Acid Amplification Screening for Blood Donors in Guangzhou

【目的】评价核酸扩增技术（NAT）在广州市献血员血液筛查的应用价值。【方法】收集22139名无偿献血员血样，采用酶联免疫吸附试验（ELISA）检测乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）、梅毒螺旋体（TP）和人免疫缺陷病毒（HIV），并检测谷丙转氨酶（ALT）水平。对四项ELISA检测阴性和ALT≤40U／L者血样，用COBASs201系统进行HBVDNA、HCVRNA、HIVRNA检测。NAT反应性样本、HBV、HCV和HIVELISA检测阳性血样以COBASAmpliScreen试剂盒鉴定。【结果】22139名献血员中，21776例双试剂血清免疫学检测阴性，其中19例为NAT反应阳性，检出率0．087％（19／21776），后经NAT鉴定检测，HBV、HCV和HIV反应阳性检出率分别为0．051％（11／21776）、0．028％（6／21776）和0．009％（2／21776）。126例HBsAg阳性样本中，25例NAT阴性，其中15例HBsAg中和试验阳性，为低水平慢性感染携带者。50例anti‐HCV阳性血样，4例为NAT阴性，补充ELISA检测为anti‐HCV阴性。16例anti‐HIV阳性样本中，7例为NAT阴性，其单样品核酸检测（ID‐NAT）和补充ELISA检测均为anti‐HIV阴性。【结论】NAT血液筛查对HBV、HCV和HIV经ELISA检测阴性样本的检出率较高，在该地开展NAT血液筛查，对于降低输血残余危险有重大意义。少量HBsAg阳性的低水平感染慢性携带者，汇集核酸检测（MP‐NAT）阴性，HBsAg筛查依然是必不可少的筛查手段。

[Objective] To evaluate the application value of nucleic acid amplification technology （NAT） in screening of blood donors in Guangzhou .[Methods] Blood samples from 22 ,139 blood donors in Guangzhou were collected .Enzyme‐linked immunosorbent assay （ELISA） was used to detect the levels of hepatitis B sur‐face antigen （HBsAg ） ,anti‐hepatitis C virus （anti‐HCV ） ,anti‐human immunodeficiency virus （anti‐HIV ） and anti‐Treponemia pallid （anti‐TP） .And the level of alanine transaminase （ALT） was also measured .For samples with negative ELISA result and ALT value 〈40 U/L ,COBAS s 201system was employed to perform NAT testing to detect the levels of HBV DNA ,HCV RNA and HIV RNA .And the positive samples were then verified with COBAS AmpliScreen test .The seropositive samples were also submitted for NAT tests .[Results] A total of 21 ,776 from 22 ,139 samples were seronegative .And 19 of them were identified as NAT reactive with a yield rate of 1/1146（0 .087% ） .NAT verification indicated that 11 ,6 and 2 cases were NAT reactive for HBV ,HCV ,and HIV respectively with yield rates of 0 .051% ,0 .028% and 0 .009% respective‐ly .Among 126 HBsAg positive samples ,25 of them were NAT non‐reactive and 15 positive in neutralization tests and conformed as low‐level chronic carriers .Among 50 anti‐HCV positive cases ,4 were NAT non‐reac‐tive and negative in supplemental ELISA test .And among 16 anti‐HIV seropositive cases ,7 were ID‐NAT non‐reactive and negative in supplemental ELISA test .[Conclusion]Yield rates of NAT screening are relative‐ly high for HBV DNA ,HCV RNA and HIV RNA in seronegative blood samples in Guangzhou .And NAT screening is valuable in blood donors .In few chronic carriers of low‐level viremia with positive HBsAg ,MP‐NAT screening is non‐reactive so that HBsAg detection remains an indispensable method of blood screening .