Department of Respiratory Medicine, Ichinomiyanishi Hospital, Ichinomiya, Japan.
Systematic Review Workshop Peer Support Group (SRWS-PSG), Osaka, Japan.
Am J Nephrol. 2021;52(7):531-538. doi: 10.1159/000518362. Epub 2021 Aug 19.
The sensitivity and specificity of anti-glomerular basement membrane (GBM) antibodies have not been systematically analyzed. In this systematic review, we aimed to evaluate the diagnostic accuracy of anti-GBM antibodies for anti-GBM disease.
Potential studies were searched using MEDLINE, Embase, the Cochrane Library, and the International Clinical Trials Registry Platform based on the index test and target condition. The inclusion criteria were prospective or retrospective cohort studies or case-control studies assessing the sensitivity and specificity of anti-GBM antibodies, and the reference standard was clinical diagnosis including biopsy results. The exclusion criteria were review articles, case reports, animal studies, and in vitro studies. Quality assessment was conducted based on the Quality Assessment of Diagnostic Accuracy Studies-2. The pooled estimates of sensitivity and specificity were calculated using a bivariate random-effects model. The overall quality was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation. Six studies (1,691 patients) and 11 index tests were included in our systematic review. A high risk of bias and concerns regarding the applicability of patient selection were noted because of the case-control design in 67% of the included studies. The pooled sensitivity and specificity were 93% (95% CI: 84-97%) and 97% (95% CI: 94-99%), respectively. The certainty of evidence was low because of the high risk of bias and indirectness. Key Messages: Anti-GBM antibodies may exhibit high sensitivity and specificity in the diagnosis of anti-GBM disease. Further cohort studies are needed to confirm their precise diagnostic accuracy and compare diagnostic accuracies among different immunoassays.
抗肾小球基底膜(GBM)抗体的敏感性和特异性尚未得到系统分析。在这项系统评价中,我们旨在评估抗 GBM 抗体对抗 GBM 疾病的诊断准确性。
根据索引试验和目标情况,使用 MEDLINE、Embase、Cochrane 图书馆和国际临床试验注册平台搜索潜在的研究。纳入标准为前瞻性或回顾性队列研究或病例对照研究,评估抗 GBM 抗体的敏感性和特异性,参考标准为包括活检结果在内的临床诊断。排除标准为综述文章、病例报告、动物研究和体外研究。根据诊断准确性研究质量评估-2 进行质量评估。使用双变量随机效应模型计算敏感性和特异性的汇总估计值。使用推荐评估、制定和评估的等级对整体质量进行评估。
本系统评价共纳入 6 项研究(1691 例患者)和 11 项指标检测。由于 67%的研究采用病例对照设计,存在较高的偏倚风险和对患者选择适用性的关注。汇总的敏感性和特异性分别为 93%(95%CI:84-97%)和 97%(95%CI:94-99%)。由于存在较高的偏倚风险和间接性,证据的确定性较低。
抗 GBM 抗体在抗 GBM 疾病的诊断中可能具有较高的敏感性和特异性。需要进一步的队列研究来确认其确切的诊断准确性,并比较不同免疫测定方法的诊断准确性。