摘要
目的评价Trustline结核抗体IgG/IgM检测试剂盒临床应用效果。方法选用3家医院的1009份血清标本,其中628份为结核病患者血清(308例菌阳病例,320例菌阴病例);对照组381份非结核病血清。采用Trustline试剂盒及一种已上市的试剂盒(对照试剂盒)分别检测1009份血清,计算多项检测指标,从而评价试剂盒的检测效果。结果通过检测1009份临床血清标本,Trustline试剂盒检测血清抗体(IgG+IgM)的灵敏度、特异度、阳性预测值、阴性预测值、Youden指数分别为61.3%、79.8%、83.3%、55.6%和0.411,对照试剂盒检测血清抗体(IgG)的结果分别为53.7%、89.0%、88.9%、53.8%和0.426。经统计分析表明Trustline试剂盒的灵敏度显著优于对照试剂盒(P<0.01),特异度低于对照试剂盒(P<0.01),但阳性诊断效率和阴性诊断效率方面差异无统计学意义,Youden指数相接近。进一步分析显示Trustline试剂盒对菌阳样本及菌阴样本的检出率分别77.6%和44.7%,对照试剂盒则为67.9%和40.0%,对菌阳样本检出率的差异有统计学意义。检测1009份标本,Trustline试剂盒共得IgM阳性35例,其中结核组阳性30例(4.8%),非结核组阳性5例(1.3%)。结论 Trustline试剂盒检测结核抗体的灵敏度显著优于对照结核抗体试剂盒,并可同时用于检测IgG/IgM抗体,可以应用于结核病的快速诊断。
Objective To evaluate the application of a newly approved serological diagnostic kit for tuberculosis （TB） diagnosis： Tmstline TB IgG/IgM rapid test kit. Methods In this multiple center study, 1009 serum specimens were collected from three hospitals and tested with Trustline TB IgG/IgM rapid test kit and a commercial TB Ab （IgG） colloid gold test kit （control test）. Among the 1009 specimens, 628 were from TB patients and 381 were from non TB individuals. By gold standard bacteriological tests, 308 of the 628 specimens were positive and 320 were negative. Results The sensitivity, specificity, positive predict value, negative predict value and Youden index on the 1009 specimen detection by the Tmstline TB IgG/IgM rapid test kit was 61.3%, 79. 8%, 83.3%, 55.6% and 0. 411 respectively, and 53.7%, 89. 0%, 88. 9%, 53.8% and 0. 426 by the control test kit. The differences in sensitivity and specificity between the two tests were statistically significant （P 〈 0. 01 ）. Further analysis showed that the detection rate of TrustlIne IgG/IgM test kit was 77. 6% for positive specimens and 44. 7% for negative specimens, while the related detection rates of the control test kit were 67.9% and 40. 0% respectively; there was significant difference in positive specimen detection between the two kits. In addition, this study showed that 35 of the 1009 specimens were IgM positive by Trustline test kit, in which 30 （4. 8% ） were from TB patients, and 5 （ 1.3% ） were from non TB individuals. Conclusion Trustline TB IgG/IgM rapid test kit is more sensitive in the detection of TB antibody in serum specimens compared with control test kit. The Trusline TB IgG/IgM test kit can detect both IgG and IgM in one test. It is recommended to be sued as TB screening test kit.
出处
《疾病监测》
CAS
2013年第10期861-865,共5页
Disease Surveillance
关键词
结核病
血清学诊断
免疫层析胶体金
tuberculosis
serodiagnosis
colloid gold immunochromatographic assay
