诊断研究评估一种新型尿液抗原检测方法的性能- 2014-2017 年奥地利三家转诊大学医院的全国性研究。
Diagnostic Study to Assess the Performance of a New Urinary Antigen Test-A National Study in Three Referral University Hospitals in Austria during 2014-2017.
机构信息
Institute for Surveillance & Infectious Disease Epidemiology, Austrian Agency for Health and Food Safety (AGES), Währingerstrasse 25a, 1090 Vienna, Austria.
Department of Global Public Health, Karolinska Institutet, 17177 Stockholm, Sweden.
出版信息
Int J Environ Res Public Health. 2022 Dec 13;19(24):16705. doi: 10.3390/ijerph192416705.
BACKGROUND
We evaluated the performance of a rapid diagnostic antigen test (Coris) as an index test versus the urinary Antigen ELISA (Bartels) as the reference test.
METHODS
Prospective diagnostic accuracy study (2014-2017) at three university hospitals in Austria.
RESULTS
A total of 996 patients were included in the study. Legionellosis was diagnosed in 49/996 (4.9%) using the reference test. The sensitivity and specificity of the Coris test were 75.5% (95% CI 61.1-86.7%) and 100% (95%CI 99.6-100%), respectively. The PPV was 100% and when using the lower 95% CI limit of the estimate for sensitivity, the resulting PPV was 61.1%. The NPV was 98.7% and the accuracy was 98.8%. The index test showed a PPV > 97% during the period of summer and autumn (May through November) and ≥88% during winter (December through February). The NPV was >97% during all of the periods. The median of the monthly incidence in the general population was 0.1 per 100,000 (IQR 0.1; 0.3).
CONCLUSION
The new rapid test gave a high level of diagnostic accuracy in a rapid fashion. The test can be applied at the bedside by non-laboratory staff.
背景
我们评估了一种快速诊断抗原检测（Coris）作为指标检测与尿抗原 ELISA（Bartels）作为参考检测的性能。
方法
在奥地利的三家大学医院进行了前瞻性诊断准确性研究（2014-2017 年）。
结果
共有 996 例患者纳入本研究。使用参考检测，军团病的诊断率为 49/996（4.9%）。Coris 试验的灵敏度和特异性分别为 75.5%（95%CI 61.1-86.7%）和 100%（95%CI 99.6-100%）。PPV 为 100%，当使用灵敏度估计值的较低 95%CI 限时，PPV 为 61.1%。NPV 为 98.7%，准确性为 98.8%。在夏季和秋季（5 月至 11 月）期间，该指标检测的 PPV ＞97%，冬季（12 月至 2 月）期间≥88%。在所有时间段，NPV ＞97%。普通人群中每月的发病率中位数为每 10 万人 0.1 例（IQR 0.1；0.3）。
结论
新型快速检测以快速的方式提供了高度的诊断准确性。该检测可由非实验室人员在床边进行应用。
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