胶体金法检测输血相关传染病的风险评估

Evaluation of the Safety of the Collodial Gold Immune Chromatography for Screening Transfusion Transmitted Infectious Diseases

目的:评估胶体金免疫层析法(G ICA)在不同温度、不同时间下检测输血相关传染病(HBsAg、抗-H IV、抗-HCV、梅毒抗体)的风险。方法:随机选取酶联免疫吸附法(ELISA)检测HBsAg、抗-H IV、抗-HCV、梅毒抗体阳性的115例标本,采用G ICA法分别在4℃、22℃、37℃进行检测,并在5分钟、10分钟、20分钟和30分钟4个时间段观察结果并与ELISA检查结果进行比较。结果:观察30分钟G ICA检测HBsAg、梅毒抗体与ELISA法的符合率为96.7%,抗-HCV与ELISA的符合率为93.3%,抗-H IV与ELISA法的符合率为100%,差异无统计学意义(P>0.05)。在G ICA检测中,除HBsAg外,温度对G ICA检测的其他三项均有影响,随温度的升高检出率提高,在不同时间段G ICA检测四项传染病指标的阳性率比较差异有统计学意义(P<0.01)。将试验观察测时间从20分钟延长至30分钟时可明显提高G ICA与ELISA检测的符合率。结论:G ICA与ELISA有较好的符合性,但G ICA仍存在一定的漏检风险。

Objective：To evaluate the safety of the collodial gold immune chromatography （GICA）for screening transfusion transmitted infectious diseases （ HBsAg, Anti-HIV, Anti- HCV, Anti-syphilis antibodies） in different temperatures and times. Methods： 115 samples of positive sera were randomly selected according to results of ELISA tests. The selected positve sera were detected by GICA in different temperatures （4℃ ,22℃ and 37℃ ）and times （5 min, 10 min,20 min and 30 min）respectively. Results： Samples tested for HbsAg and anti-syphilis antibody were 96.7% concordant with the results of ELISA. Samples tested for anti- HCV were 93.3% concordant with the results of ELISA. Samples tested for anti-HIV were 100% concordant with the results of ELISA with no significant difference. In GICA test,temperatures had influence on the other 3 items of GICA except HbsAg detection rate increased with temperature and the positive rate during different stages of GICA showed significant difference （ P 〈 0. 01 ）. Coincidence rate significantly increased in GICA and ELISA when observation time was extended from 20 min to 30 min. Conclusion：The results of GICA were well concordant with those of ELISA. However,certain risk of GICA still exists.