献血者抗-HCV不合格标本RIBA确认结果分析

目的分析献血人群ELISA试剂抗-HCV不合格标本确认结果,探讨抗-HCV ELISA试剂组合及灰区限的设置。方法收集113份ELISA试剂抗-HCV不合格标本,采用重组免疫印迹实验(RIBA)进行确认,并比较不同ELISA试剂的检测情况。结果 113份ELISA检测不合格标本中,RIBA确认阳性46份,不确定39份,阴性28份。确认阳性比例为40.7%。RIBA确认阳性的标本中,2种抗-HCV ELISA试剂检测结果均呈阳性反应的有44份;1种抗-HCV ELISA试剂呈阳性反应的标本中,RIBA确认阳性有2份,其余为阴性或不确定;灰区标本中,确认结果均为不确定或阴性。2种ELISA试剂检测均呈阳性反应的标本中,确认阳性率为78.57%。结论选用国产和进口试剂相组合,并设定灰区限,对保证血液安全意义重大。

The RIBA Confirmation of Anti-HCV ELISA Positive Samples from Blood Donors

Objective To analyze the results of RIBA confirmation for anti-HCV ELISA positive samples from blood donors, and to study the combination of anti-HCV ELISA reagents and the setting of grey area. Methods A total of 113 anti-HCV positive sample identified by ELISA were tested by using the restructuring immune imprinting （RIBA）. Resuits Forty-six samples （40.70//00, 46/113） were confirmed positive by RIBA, 41 samples were uncertain, and 26 samples were negative. Among the 46 RIBA confirmed HCV positive samples, the test results of 2 kinds of anti-HCV ELISA reagents were both positive for 44 samples. The 2 samples were positive with only one of reagents ,others were negative or uncertain. Among the specimens with anti-HCV results in the grey area, the RIBA confirmation showed either uncertain or negative. In the anti-HCV positive samples identified by 2 ELISA reagents, the rate of confirmed positivity was 83.0%. Conclusion For ensuring the safety of blood, it＇s very important to use combination of the domestic and overseas anti- HCV ELISA reagents and to set a proper grey area.