摘要
目的评估核酸检测技术(NAT)应用于献血者血液筛查的效果和必要性。方法采用美国诺华ProcleixTIGRIS全自动NAT检测分析系统和PROCLEIX ULTRIOAssay HBV、HCV、HIV(1型)NAT联检试剂,对616 705例无偿献血者血液标本做HBV、HCV、HIV 3项NAT联检,并对单项NAT阳性标本做NAT鉴别试验;同时采用血清学酶免(EIA)双试剂并行检测同批标本的HBsAg、抗-HCV、抗-HIV、抗-TP和ALT等项目。结果 NAT阳性检出率为0.95%(5 874/616 705),EIA检测HBsAg、抗-HCV、抗-HIV3项的阳性检出率为1.62%(10 048/616705)(P<0.01)。EIA检测全项合格标本的NAT阳性检出率为0.22%(1 365/594 325);单项NAT阳性标本的NAT鉴别试验阳性率为30.4%(415/1 365),其中HBV DNA阳性413例,占NAT鉴别试验阳性总数的99.52%,HCV RNA和HIV RNA阳性各1例;EIA双试剂检测阳性标本的NAT阳性检出率75.28%(4 148/5 510),EIA单试剂检测阳性标本的NAT阳性率检出率为2.27%(103/4 538);ALT EIA双试剂检测不合格标本的核酸NAT阳性检出率2.31%(336/14 554),其中单项ALT检测不合格标本的NAT阳性检出率为0.01%(2/14 080),而且半年后对这些献血者随访NAT复检均为阴性。结论目前广州地区血清学EIA检测合格血液中存在的输血传播疾病风险主要是输血感染HBV;将NAT检测应用于献血者血液筛查,有助于进一步提高血液安全。
Objective To investigate the effectiveness and necessity of nucleic acid test for blood screening. Methods Novartis Procleix TIGRIS automatic nucleic acid test and analysis system and PROCLEIX ULTRIO assay were performed to jointly detect HBV,HCV and HIV-1 in 616 705 blood donors. Moreover,nucleic acid identification test was used to identify NAT positive alone samples. Furthermore,HBsAg,anti-HCV, anti-HIV,anti-TP and ALT were test by serological reagent. Results Of 616 705 blood donors samples,1. 62 %（ 10 048 / 616 705） were EIA positive and 0. 95%（ 5 874 /616 705） were NAT positive. There was a significant difference between EIA positive and NAT positive. Of 594 325 ELISA negative blood donors,0. 22 %（ 1 365 /594 325） were NAT positive. Of 1365 only NAT positive blood donors,including 143 HBV DNA positive,1 HCV positive and 1 HIV positive,30. 4%（ 415 /1 365） were nucleic acid identification test positive. Of 5 510 two EIA reagent positive blood donors,75. 28% were NAT positive. But only 2. 27%（ 103 /4 538） NAT positive was found in one EIA reagent positive blood donors. 14 554 cases of ALT double reagent unqualified samples,NAT positive rate was 2. 31%（ 336 /14 554）. Among them,14 080 cases of single ALT detection of unqualified specimen,nucleic acid were detected in 2 cases,the positive rate is 0. 01%,and after six months follow-up of donors,NAT test were negative. Conclusion The present risk of transfusion transmitted disease mainly was HBV infection. Nucleic acid test technique was used for blood screening,which will help to shorten the window period of blood transfusion infection and further improve blood safety.
出处
《中国输血杂志》
CAS
CSCD
北大核心
2013年第12期1211-1214,共4页
Chinese Journal of Blood Transfusion
基金
卫生部行业科研专项(201002005)
广州市重大科技专项(2010UI-E00661)
广州市医药卫生重点项目(201102A212010)
