摘要
目的对罗氏公司生产的弓形体(toxoplasma,TOX)IgG抗体亲和力检测试剂进行临床应用评估,为临床资料提供参考依据。方法收集TOX-IgG和TOX-IgM均阳性的标本130份,同时用被考核试剂(罗氏公司产品)和参考试剂进行TOX-IgG抗体亲和力检测,计算被考核试剂IgG抗体亲和力检测的相对灵敏度、相对特异度、相对总符合率。结果经参考试剂检测,34份为高亲和力抗体,其中被考核试剂检测为高亲和力的25份、低亲和力3份、灰区6份;92份为低亲和力抗体,其中被考核试剂检测为低亲和力72份、高亲和力12份、灰区8份;4份为灰区,被考核试剂检测为低亲和力抗体3份、灰区1份;即被考核试剂的相对灵敏度为89.3%、相对特异度为85.7%、相对总符合率为86.6%。结论罗氏公司的弓形体IgG抗体亲和力检测试剂盒的灵敏度、特异性均>85%,达到检测试剂临床应用的性能要求。
OBJECTIVE To evaluate the performance of Roche＇s product, IgG antibody affinity reagents kit for the toxoplasma （TOX）, so as to provide evidence for the clinical data. METHODS Totally 130 specimens with both TOX-IgG and TOX-IgM tested positive were collected, then the TOX-IgG affinity was tested by respectively using the study reagents （Roche＇s product） and reference reagent, and the relative sensitivity and specificity as well as the relative total coincidence rate of the study reagents for the test of IgG affinity were calculated. RESULTS The result of test of the reference reagents showed that there were 34 specimens of high affinity antibodies, including 25 specimens of high affinity antibodies tested with the study reagents, 3 specimens of low affinity antibodies, and 6 specimens in gray areas there were 92 specimens of low affinity antibodies, including 72 specimens of low affinity tested with the study reagents, 12 specimens of high affinity, and 8 specimens in gray areas there were 4 specimens in gray area, including 3 specimens of low affinity tested with the study reagents and 1 specimens in gray area. The relative sensitivity of the study reagent was 89. 3%, the relative specificity 85. 7%, the relative total coincidence rate 86.6 %. CONCLUSION Both the sensitivity and specificity of the Roehe＇s toxoplasma （TOX） IgG affinity test kit are higher than 85%, which meets the performance requirements of the clinical application of test reagents.
出处
《中华医院感染学杂志》
CAS
CSCD
北大核心
2013年第24期5933-5934,5940,共3页
Chinese Journal of Nosocomiology
基金
云南省科技计划面上基金项目(2011FB216)
解放军总医院科技创新苗圃基金项目(13KMM40)
