科华和Murex梅毒螺旋体酶联免疫吸附试验的Kappa一致性分析  

Kappa consistency analysis between Kehua TP-ELISA and Murex TP-ELISA

作　　者：张秋丽[1] 周俊[1] 郭彦青[1] 

机构地区：[1]北京军区总医院输血科,100700

出　　处：《山西医药杂志》2015年第15期1747-1749,共3页Shanxi Medical Journal

摘　　要：目的通过对2种梅毒螺旋体酶联免疫吸附试验(TP-ELISA)检测方法一致性的研究,为选择最佳的血液筛查方法提供了理论基础,以确保输血安全。方法利用科美生物免疫化学试剂盒检测2014年1月至9月我院所有门诊和住院患者的梅毒待检标本;其中可疑和阳性标本利用科华TP-ELISA和Murex TP-ELISA分别进行双孔复检;利用SAS 9.2软件对可疑和阳性复检结果进行Kappa一致性分析,并对可疑和阳性结果分别进行Kappa一致性分析,并对Kappa系数进行了U检验。结果科美生物免疫化学试剂盒检测所有标本中共754份可疑和阳性结果,其中171份为可疑结果,583份为阳性结果;科华TP-ELISA检测754份标本,阴性、可疑和阳性结果分别为85(11%)、19(3%)和650(86%),Murex TP-ELISA结果为173(23%)、29(4%)和552(73%)。2种方法针对可疑及阳性标本、阳性标本和可疑标本的Kappa系数分别为Kappa=0.480 0,95%CI=(0.409 6,0.550 5);Kappa=0.379 5,95%CI:(0.231 2,0.527 9);Kappa=0.010 8;95%CI=(-0.078 7,0.100 4)。结论 2种方法针对可疑阳性标本和阳性标本有较好的一致性,而仅针对可疑标本时2种方法的一致性可能是由机器造成的。针对可疑标本应采用其他更敏感特异的实验进行验证。Objective To provide scientific materials for selecting the best method of blood screening and to ensure the safety of blood transfusion in our country by performing kappa consistency analysis of 2 type TP-ELISA methods. Methods All the syphilis inspected samples which were collected from the outpatients and inpatients in the Military Gen- eral Hospital of Beijing from January to September 2014, were detected by Kernel Immunohistochemistry kits. Among them, the suspicious and positive specimens were re-inspected by Kehua TP-ELISA and Murex TP-ELISA. Kappa con- sistency analysis of the re-inspected results of suspicious and positive samples was carried out on SAS 9.2 software and u test of Kappa coefficient was performed. Results Among all the samples, 754 suspicious and positive specimens were de- tected by Kernel Immunohistochemistry kits, which included 171 suspicious and 583 positive specimens. Of 754 specimens re-inspected by Kehua TP-ELISA showed negative, suspicious, positive specimens were 85 （11 %）, 19 （3 %） and 650 （86 % ）, respectively. The re-inspected results by Murex TP-ELISA was 173 （23 % ） negative, 29 （4 % ） suspicious and 552（73%） positive. Kappa coefficient of suspicious-positive specimens, suspicious specimens and positive specimens by two TP-ELISA methods were 0. 480 0, 95 % CI ：（0. 409 6,0. 550 5） ; 0. 379 5, 95 % CI ..（0. 231 2,0. 527 9） ; 0. 010 8, 95 % CI ： （- 0. 078 7,0. 100 4）, respectively. Conclusion There is a good consistency of suspicious-positive and positive specimens by two TP-ELISA methods. Consistency of the two methods for suspicious specimens was caused by opportu- nity. Suspicious specimens should be confirmed by other more sensitive and specific methods, such as PCR, WB and rab- bit infectivity testing and so on.

关 键 词：梅毒血清诊断 酶联免疫吸附测定 Kappa一致性分析 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]