MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; CINTESIS, Center for Health Technology and Services Research, Faculty of Medicine, University of Porto, Porto, Portugal; Basic and Clinical Immunology Unit, Department of Pathology, Faculty of Medicine, University of Porto, Porto, Portugal.
MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal.
J Allergy Clin Immunol. 2021 Jan;147(1):296-308. doi: 10.1016/j.jaci.2020.04.058. Epub 2020 May 21.
Having a penicillin allergy label associates with a higher risk for antibiotic resistance and increased health care use.
We sought to assess the accuracy of skin tests and specific IgE quantification in the diagnostic evaluation of patients reporting a penicillin/β-lactam allergy.
We performed a systematic review and diagnostic accuracy meta-analysis, searching on MEDLINE, Scopus, and Web of Science. We included studies conducted in patients reporting a penicillin allergy and in whom skin tests and/or specific IgE quantification were performed and compared with drug challenge results. We quantitatively assessed the accuracy of diagnostic tests with bivariate random-effects meta-analyses. Meta-regression and subgroup analyses were performed to explore causes of heterogeneity. Studies' quality was evaluated using QUADAS-2 criteria.
We included 105 primary studies, assessing 31,761 participants. Twenty-seven studies were assessed by bivariate meta-analysis. Skin tests had a summary sensitivity of 30.7% (95% CI, 18.9%-45.9%) and a specificity of 96.8% (95% CI, 94.2%-98.3%), with a partial area under the summary receiver-operating characteristic curve of 0.686 (I = 38.2%). Similar results were observed for subanalyses restricted to patients reporting nonimmediate maculopapular exanthema or urticaria/angioedema. Specific IgE had a summary sensitivity of 19.3% (95% CI, 12.0%-29.4%) and a specificity of 97.4% (95% CI, 95.2%-98.6%), with a partial area under the summary receiver-operating characteristic curve of 0.420 (I = 8.5%). Projected predictive values mainly reflect the low frequency of true penicillin allergy.
Skin tests and specific IgE quantification appear to have low sensitivity and high specificity. Because current evidence is insufficient for assessing the role of these tests in stratifying patients for delabeling, we identified key requirements needed for future studies.
青霉素过敏标签与抗生素耐药性风险增加和医疗保健利用增加相关。
我们旨在评估皮试和特异性 IgE 定量在报告青霉素/β-内酰胺过敏的患者的诊断评估中的准确性。
我们进行了系统评价和诊断准确性荟萃分析，在 MEDLINE、Scopus 和 Web of Science 上进行了搜索。我们纳入了在报告青霉素过敏的患者中进行皮试和/或特异性 IgE 定量并与药物挑战结果进行比较的研究。我们使用双变量随机效应荟萃分析定量评估诊断测试的准确性。进行了荟萃回归和亚组分析以探索异质性的原因。使用 QUADAS-2 标准评估研究质量。
我们纳入了 105 项主要研究，评估了 31761 名参与者。27 项研究进行了双变量荟萃分析。皮试的综合敏感性为 30.7%（95%CI，18.9%-45.9%），特异性为 96.8%（95%CI，94.2%-98.3%），综合受试者工作特征曲线下面积为 0.686（I=38.2%）。对于仅报告非即刻性斑丘疹或荨麻疹/血管性水肿的患者的亚分析，也观察到类似的结果。特异性 IgE 的综合敏感性为 19.3%（95%CI，12.0%-29.4%），特异性为 97.4%（95%CI，95.2%-98.6%），综合受试者工作特征曲线下面积为 0.420（I=8.5%）。预测值主要反映了青霉素过敏的低发生率。
皮试和特异性 IgE 定量似乎具有低敏感性和高特异性。由于目前的证据不足以评估这些测试在对患者进行去标签分层中的作用，因此我们确定了未来研究的关键需求。
