国内斑点免疫金胶体渗滤法检测结核抗体诊断结核病的文献质量评价

Assessing the Quality of Diagnostic Studies on Using Dot Immunogold Filtration Assay to Diagnose Tuberculosis

目的评价国内斑点免疫金胶体渗滤法检测结核抗体诊断结核病的文献质量。方法计算机检索中国生物医学文献数据库(CBM,1978～2006)和中文科技期刊全文数据库(VIP,1994～2006),纳入斑点免疫金胶体渗滤法检测结核抗体诊断结核病的所有诊断性研究文献,按QUADAS质量评价标准评估,由两位研究者独立进行文献质量评估。若遇分歧,讨论解决。结果共检索到38篇相关文献,质量评价结果显示,大多数文献与QUADAS质量评价标准的符合率不高。多数文献采用回顾性病例对照研究设计,其中31篇未清楚描述研究对象的选择标准,18篇不能确定是否所有研究对象均经金标准核实,36篇不清楚诊断试验结果的解释是否采用盲法,37篇未描述是否有难以解释的结果,34篇未描述是否有退出病例。结论国内斑点免疫金胶体渗滤法检测结核抗体诊断结核病的诊断性研究质量还有待提高。

Objective To assess the quality of diagnostic studies on detecting the tuberculosis antibody to diagnose tuberculosis. Methods CBM （1978 to 2006） and VIP （1994 to 2006） were searched; any author-claimed diagnostic studies which used the dot immunogold filtration assay （DIGFA） to detect the tuberculosis antibody and to diagnose tuberculosis were included. The Quality Assessment of Diagnostic Accuracy Studies （QUADAS） was used to assess the quality of included diagnostic studies by two reviewers independently. Results Thirty-eight papers were included and assessed. We found that most of the quality items were not met with QUADAS. Most papers adopted the retrospective diagnostic case-control design. Thirty-one papers did not describe the selection criteria clearly, 18 did not describe whether all the included patients were verified by using a reference standard of diagnosis, 36 did not describe whether the index test results were interpreted without knowledge of the results of the reference standard, 37 did not report the uninterpretable/intermediate test results, and 34 did not report the withdrawals fi＇om the study. Conclusion There are few high quality studies on using DIGFA to detect tuberculosis antibody to diagnose tuberculosis.