Department of Anesthesiology, Intensive Care, Emergency Medicine and Pain Therapy, Schwarzwald-Baar Hospital, Villingen-Schwenningen.
Witten/Herdecke University, Faculty of Health, School of Medicine, Witten.
Eur J Emerg Med. 2022 Aug 1;29(4):285-290. doi: 10.1097/MEJ.0000000000000928. Epub 2022 Apr 12.
Rapid antigen point-of-care tests (antigen POC tests) are frequently used to detect COVID-19 infections. Based on clinical impressions, we suspected that the sensitivity of antigen POC tests might be lower in vaccinated patients.
To evaluate the sensitivity of antigen POC tests in vaccinated patients.
DESIGN, SETTING AND PARTICIPANTS: We retrospectively evaluated all patients over 18 years of age that tested positive for severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in November 2021 at our institution, whose antigen POC test result had been recorded. We considered patients who were either fully vaccinated or unvaccinated, as well as whether they were symptomatic.
We calculated the sensitivity of antigen POC tests in vaccinated and unvaccinated as well as in symptomatic and asymptomatic patients and compared the results.
A total of 4080 reverse transcription PCR tests were performed in our institution in November 2021, of which 360 patients tested positive for SARS-CoV-2. Of those, 234 patients met inclusion criteria and were further evaluated. The sensitivity of the antigen POC test was only 39.4% [95% confidence interval (CI), 31.3-48.1%] in vaccinated patients and differed significantly from the sensitivity of 53.3% (95% CI, 43.9-62.4%) in unvaccinated patients (difference of sensitivities, 13.9%; 95% CI, 1.1-26.1%). In symptomatic patients, the sensitivity increased by only 11.8% from 45.7% in all patients (95% CI, 39.5-52.1%) to 57.5% in symptomatic patients (95% CI, 49.9-64.7%). In asymptomatic patients, the antigen POC test was only able to detect SARS-CoV-2 positive patients in 16.4% of the cases (95% CI, 9.4-27.1%).
Point-of-care antigen tests are likely not useful for ruling out SARS-CoV-2 infection, especially in vaccinated and asymptomatic patients, potentially due to lower viral load. Moreover, the use of these tests might lead to a false sense of security, especially when used by the public as part of a public health testing strategy.
快速抗原即时检测（抗原 POCT 检测）常用于检测 COVID-19 感染。根据临床印象，我们怀疑抗原 POCT 检测在接种疫苗的患者中的敏感性可能较低。
评估接种疫苗患者的抗原 POCT 检测的敏感性。
设计、设置和参与者：我们回顾性评估了 2021 年 11 月在我们机构检测出严重急性呼吸综合征冠状病毒 2 型（SARS-CoV-2）阳性的所有 18 岁以上患者的检测结果，这些患者的抗原 POCT 检测结果均有记录。我们考虑了完全接种疫苗或未接种疫苗的患者，以及他们是否有症状。
2021 年 11 月，我们机构共进行了 4080 次逆转录聚合酶链反应（RT-PCR）检测，其中 360 例 SARS-CoV-2 检测呈阳性。其中，234 例符合纳入标准，并进一步进行了评估。抗原 POCT 检测的敏感性在接种疫苗的患者中仅为 39.4%[95%置信区间（CI），31.3-48.1%]，与未接种疫苗的患者 53.3%（95%CI，43.9-62.4%）的敏感性差异显著（敏感性差异，13.9%；95%CI，1.1-26.1%）。在有症状的患者中，敏感性仅从所有患者的 45.7%（95%CI，39.5-52.1%）增加了 11.8%，达到 57.5%（95%CI，49.9-64.7%）。在无症状患者中，抗原 POCT 检测仅能在 16.4%的情况下检测到 SARS-CoV-2 阳性患者（95%CI，9.4-27.1%）。
POC 抗原检测可能不适用于排除 SARS-CoV-2 感染，尤其是在接种疫苗和无症状患者中，可能是由于病毒载量较低。此外，这些检测的使用可能会导致一种虚假的安全感，尤其是当公众将其作为公共卫生检测策略的一部分使用时。
