Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.
Equalis AB, Uppsala, Sweden.
Eur J Clin Microbiol Infect Dis. 2021 Mar;40(3):549-558. doi: 10.1007/s10096-020-04034-z. Epub 2020 Sep 29.
Sensitivity and specificity of rapid antigen detection tests (RADTs) for detection of group A hemolytic streptococcus (GAS) vary. The purpose is to present the first SKUP (Scandinavian evaluation of laboratory equipment for point of care testing) evaluations concerning the assessment of the diagnostic performance and user-friendliness of two RADTs for detection of GAS when used under real-life conditions in primary health care. Throat samples were collected in duplicates at primary health care centers (PHCCs) from patients with symptoms of pharyngitis. The performance of QuickVue Dipstick Strep A test (307 samples) and DIAQUICK Strep A Blue Dipstick (348 samples) was evaluated using culture results at a clinical microbiology laboratory as comparison. The user-friendliness was evaluated using a questionnaire. The diagnostic sensitivity was 92% (90% confidence interval (CI) 87-96%) and 72% (90% CI 65-79%), while the diagnostic specificity was 86% (90% CI 81-90%) and 98% (90% CI 96-99%) for QuickVue Dipstick Strep A test and DIAQUICK Strep A Blue Dipstick, respectively. Both RADTs obtained acceptable assessments for user-friendliness and fulfilled SKUP's quality goal for user-friendliness. The diagnostic sensitivity for QuickVue Dipstick Strep A test and the diagnostic specificity for DIAQUICK Strep A Blue Dipstick in this objective and supplier-independent evaluation were higher compared with previous meta-analyses of RADTs. However, the diagnostic specificity for QuickVue Dipstick Strep A test and the diagnostic sensitivity for DIAQUICK Strep A Blue Dipstick were lower compared with previous meta-analyses of RADTs.
快速抗原检测试验（RADTs）检测 A 组溶血性链球菌（GAS）的敏感性和特异性各不相同。本研究旨在介绍首次 SKUP（北欧床边即时检验设备评估）评估，评估两种 RADTs 在初级保健中心实际条件下用于检测 GAS 时的诊断性能和用户友好性。从有咽炎症状的患者在初级保健中心（PHCC）采集两份咽拭子。使用临床微生物学实验室的培养结果作为比较，评估 QuickVue 试纸条 Strep A 试验（307 个样本）和 DIAQUICK Strep A 蓝色试纸条（348 个样本）的性能。使用问卷评估用户友好性。QuickVue 试纸条 Strep A 试验的诊断敏感性为 92%（90%置信区间（CI）87-96%）和 72%（90% CI 65-79%），而 DIAQUICK Strep A 蓝色试纸条的诊断特异性为 86%（90% CI 81-90%）和 98%（90% CI 96-99%）。两种 RADTs 在用户友好性方面均获得可接受的评估，满足 SKUP 的用户友好性质量目标。与之前的 RADTs 荟萃分析相比，QuickVue 试纸条 Strep A 试验的诊断敏感性和 DIAQUICK Strep A 蓝色试纸条的诊断特异性在本次客观和无供应商依赖的评估中更高。然而，QuickVue 试纸条 Strep A 试验的诊断特异性和 DIAQUICK Strep A 蓝色试纸条的诊断敏感性均低于之前的 RADTs 荟萃分析。
