无偿献血者ALT报废域值与NAT-HBV/HCV检测结果分析

Analysis of the NAT-HBV/HCV results of single ALT(+) blood donors

目的探讨无偿献血者ALT与核酸扩增技术(NAT-HBV/HCV)检测结果的相关性,为优化血液筛查策略提供理论依据。方法回顾性调查本站2006年12月—2007年12月共28 800份无偿献血者样本,用速率法进行ALT检测,ALT单项不合格样本用NAT-HBV/HCV检测;分析ALT值与ELISA-HBV/HCV-OD值的分布规律。结果共筛查出2 516份ALT单项不合格样本;经NAT-HBV/HCV检测出8份阳性,其中HBV-DNA阳性5份,HCV-RNA阳性3份;ALT≤80 U/L的献血者NAT-HBV/HCV阳性率明显低于ALT>80 U/L献血者(P<0.01);经ELISA-HBV/HCV检测OD值,95%ALT单项不合格样本ELSIA-HBV/HCV的OD值<Cut-off值的40%。结论将ALT报废域值设定为ALT≤70 U/L且ELSIA-HBV/HCV检测OD值<其Cut-off值的40%,能够较好地保证血液的安全性,并可减少血液浪费。

Objective To investigate the NAT （ nucleic acid amplification technique ） -HBV/HCV results among single ALT（ ＋ ） blood donors, in order to provide theoretical basis of optimizing strategy for blood screening. Methods A total of 28 800 samples, from December 2006 to December 2007, were studied retrospectively. ALT was tested by rate method. HBV-DNA and HCV-RNA in single ALT（ ＋ ） samples were detected via NAT-HBV/HCV. The relationship between positive ALT values and ELSIA-HBV/HCV OD values was analyzed. Results A total of 2 516 ALT（ ＋ ） cases were found in 28 800 samples. Of these ALT （ ＋ ） cases, 8 positive cases were found via NAT-HBV/HCV, including 5 HBV-DNA （ ＋ ） and 3 HCV-RNA（ ＋ ） cases. The positive rates of NAT-HBV/HCV for the donors with ALT values ≤80 U/L were significant lower than those with ALT values≥81 U/L（P 〈0. 01 ）. The ELISA-HBV/HCV OD values of 95% single ALT （ ＋ ） cases were 〈 40% of Cut-Off. Conclusion It suggests that blood safety could be further ensured and blood waste could be further reduced if the reject threshold value of ALT would be set at ≤70 U/L and the OD value of ELISA-HBV/ HCV was set to be 〈 40% of Cut-Off.