胶体金快速法在梅毒抗体检测中的应用性评价

The application evaluation for the use of TPCG in testing TPCGhilis Antibodies

目的应用胶体金法快速法（TPCG）检测血清梅毒抗体,并与梅毒螺旋体明胶颗粒凝集试验（TPPA）进行比较,对胶体金快速法的应用性进行评价。方法对29 640例（A组）需要检测梅毒的患者血清,用TPPA法检测,对结果阳性的用TPCG法复查。对4892例（B组）需要应用快速法检测梅毒的患者血清,用TPCG法检测,对结果阳性者用TPPA法复查。对8份梅毒抗体阳性血清用阴性血清进行倍比稀释,对稀释后的同一份血清分别用TPPA法和TPCG法进行定性检测,以比较TPCG法的灵敏度和可检测范围。结果 A组TPPA法检出616例阳性,用TPCG复查612例阳,阳性符合率为99.35%;阳性漏检率为0.01%;B组TPCG法共检测出91例阳性,用TPPA法复查80例阳性,符合率为87.9%。TPCG法能检测到TPPA法下限的1/2~1/4,可从下限开始检测出下限的1024倍或更高。结论 TPCG法敏感度高,漏检率低,试剂易于保存,独立包装,操作简单,结果易于判断,能满足基层医院筛查的需要,对于阳性结果,应结合症状,必要时可以到上级医院复查。

Objective Through the comparison between the use of the colloidal gold rapid screen test（TPCG）and the treponema pallidum particle agglutination（TPPA）method in testing TPCG syp hilis antibodies in serum in order to carry out an evaluation on the former＇s application in testing TPCG syphilis antibodies.Methods（1）Group A：use TPPA method to test for 29 640 cases of patients who demand to have the TPCG syphilis test and use TPCG method to do repeat tests for those positive cases.Group B：use the TPCG method to test for 4892 cases of patients who demand to have a rapid TPCG syphilis test and again use the TPPA method to do repeat tests for those positive cases.（2）Dilute the serum concentration of 8cases of tested positive serum samples to half by adding the tested negative serum.Use the TPPA method and the TPCG method respectively to run qualitative testing for the same diluted serum sample so as to know the sensitivity and detecting range of TPCG through its comparison with the former.Results As for group A,of the 616 TPPA tested positive cases,612 tested positive using the TPCG method for a repeat test,which indicates a true positive rate of 99.35%for the TPCG method,and a missed positive rate of 0.65%.As for group B,of the 91 TPCG tested positive cases,80 tested positive when using TPPA method for a repeat test,which shows 87.9% compliance.（2）The TPCG method can detect up to 1/2to 1/4of the lower limit of the TPPA method,meaning that the lower limit is 1024 times or even higher than that of the lower limits of the TPPA method.Conclusion The TPCG is characterized by high sensitivity,a low missing rate,the easy storage of reagent,individual packages,simple operation,easy judging results and the satisfaction of the screening demand for primary hospitals.For positive results,symptoms should be correlated,and a review can be made at a higher level hospital if necessary.