CAJ | 학술논문

【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。
【목적】평개핵산확증기술（NAT）재엄주시헌혈원혈액사사적응용개치。【방법】수집22139명무상헌혈원혈양，채용매련면역흡부시험（ELISA）검측을형간염병독（HBV）、병형간염병독（HCV）、매독라선체（TP）화인면역결함병독（HIV），병검측곡병전안매（ALT）수평。대사항ELISA검측음성화ALT≤40U／L자혈양，용COBASs201계통진행HBVDNA、HCVRNA、HIVRNA검측。NAT반응성양본、HBV、HCV화HIVELISA검측양성혈양이COBASAmpliScreen시제합감정。【결과】22139명헌혈원중，21776례쌍시제혈청면역학검측음성，기중19례위NAT반응양성，검출솔0．087％（19／21776），후경NAT감정검측，HBV、HCV화HIV반응양성검출솔분별위0．051％（11／21776）、0．028％（6／21776）화0．009％（2／21776）。126례HBsAg양성양본중，25례NAT음성，기중15례HBsAg중화시험양성，위저수평만성감염휴대자。50례anti‐HCV양성혈양，4례위NAT음성，보충ELISA검측위anti‐HCV음성。16례anti‐HIV양성양본중，7례위NAT음성，기단양품핵산검측（ID‐NAT）화보충ELISA검측균위anti‐HIV음성。【결론】NAT혈액사사대HBV、HCV화HIV경ELISA검측음성양본적검출솔교고，재해지개전NAT혈액사사，대우강저수혈잔여위험유중대의의。소량HBsAg양성적저수평감염만성휴대자，회집핵산검측（MP‐NAT）음성，HBsAg사사의연시필불가소적사사수단。
[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 .