Department of Emergency Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada.
JAMA Netw Open. 2022 Oct 3;5(10):e2236288. doi: 10.1001/jamanetworkopen.2022.36288.
Early and accurate diagnostic testing for SARS-CoV-2 is essential to initiate appropriate treatment and infection control and prevention measures among patients presenting to the hospital.
To evaluate the diagnostic sensitivity of the SARS-CoV-2 nucleic acid amplification test (NAAT) performed within 24 hours of arrival to the emergency department among a nationally representative sample of patients.
DESIGN, SETTING, AND PARTICIPANTS: This diagnostic study was conducted at 47 hospitals across 7 provinces in Canada participating in the Canadian COVID-19 Rapid Response Emergency Department Network among consecutive eligible patients presenting to a participating emergency department who were tested for SARS-CoV-2 from March 1, 2020, to December 31, 2021. Patients not tested within 24 hours of arrival and those presenting with a positive result from a test performed in the community were excluded.
The primary outcome was a positive result from the SARS-CoV-2 NAAT. Outcome measures were the diagnostic sensitivity and yield of the SARS-CoV-2 NAAT.
Of 132 760 eligible patients (66 433 women [50.0%]; median age, 57 years [IQR, 37-74 years]), 17 174 (12.9%) tested positive for SARS-CoV-2 within 14 days of their first NAAT. The diagnostic sensitivity of the SARS-CoV-2 NAAT was 96.2% (17 070 of 17 740 [95% CI, 95.9%-96.4%]) among all of the tests performed. Estimates ranged from a high of 97.7% (1710 of 1751 [95% CI, 96.8%-98.3%]) on day 2 of symptoms to a low of 90.4% (170 of 188 [95% CI, 85.3%-94.2%]) on day 11 of symptoms among patients presenting with COVID-19 symptoms. Among patients reporting COVID-19 symptoms, the sensitivity of the SARS-CoV-2 NAAT was 97.1% (11 870 of 12 225 [95% CI, 96.7%-97.3%]) compared with 87.6% (812 of 927 [95% CI, 85.2%-89.6%]) among patients without COVID-19 symptoms. The diagnostic yield of the SARS-CoV-2 NAAT was 12.0% (18 985 of 158 004 [95% CI, 11.8%-12.2%]) and varied from a high of 20.0% (445 of 2229 [95% CI, 18.3%-21.6%]) among patients tested on day 10 after symptom onset to a low of 8.1% (1686 of 20 719 [95% CI, 7.7%-8.5%]) among patients presenting within the first 24 hours of symptom onset.
This study suggests that the diagnostic sensitivity was high for the first SARS-CoV-2 NAAT performed in the hospital and did not vary significantly by symptom duration. Repeated testing of patients with negative test results should be avoided unless their pretest probability of disease is high.
对于因 COVID-19 而到医院就诊的患者，早期、准确的诊断检测对于启动适当的治疗以及感染控制和预防措施至关重要。
评估在急诊部门就诊后 24 小时内进行的 SARS-CoV-2 核酸扩增检测（NAAT）在全国代表性患者样本中的诊断敏感性。
设计、地点和参与者：这项诊断研究在加拿大 7 个省的 47 家医院进行，这些医院参与了加拿大 COVID-19 快速反应急诊网络，连续纳入了在参与急诊部门就诊的符合条件的患者，这些患者在 2020 年 3 月 1 日至 2021 年 12 月 31 日期间接受了 SARS-CoV-2 检测。未在 24 小时内就诊且在社区进行的检测结果为阳性的患者被排除在外。
主要结局是 SARS-CoV-2 NAAT 的阳性结果。结局指标是 SARS-CoV-2 NAAT 的诊断敏感性和检出率。
在 132760 名符合条件的患者（66433 名女性[50.0%]；中位年龄为 57 岁[IQR，37-74 岁]）中，有 17174 名（12.9%）在首次 NAAT 后 14 天内 SARS-CoV-2 检测呈阳性。所有进行的检测中，SARS-CoV-2 NAAT 的诊断敏感性为 96.2%（17070 例中有 17174 例[95%CI，95.9%-96.4%]）。估计值从症状出现第 2 天的 97.7%（1751 例中有 1710 例[95%CI，96.8%-98.3%]）到症状出现第 11 天的 90.4%（188 例中有 170 例[95%CI，85.3%-94.2%]）不等，这在有 COVID-19 症状的患者中。在报告 COVID-19 症状的患者中，SARS-CoV-2 NAAT 的敏感性为 97.1%（12225 例中有 11870 例[95%CI，96.7%-97.3%]），而在无症状患者中，敏感性为 87.6%（927 例中有 812 例[95%CI，85.2%-89.6%]）。SARS-CoV-2 NAAT 的诊断检出率为 12.0%（158004 例中有 18985 例[95%CI，11.8%-12.2%]），在症状出现后第 10 天接受检测的患者中检出率最高（20.0%，445 例中有 445 例[95%CI，18.3%-21.6%]），在症状出现后 24 小时内就诊的患者中检出率最低（8.1%，20719 例中有 1686 例[95%CI，7.7%-8.5%]）。
本研究表明，在医院进行的首次 SARS-CoV-2 NAAT 的诊断敏感性较高，且与症状持续时间无显著差异。除非患者的疾病先验概率较高，否则应避免对阴性检测结果的患者进行重复检测。
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