Department of General Practice, Julius-Maximilians-Universität Wuerzburg, Wuerzburg, Germany.
Department of General Practice, University Medical Center Goettingen, Goettingen, Germany.
BMC Prim Care. 2022 Jun 11;23(1):149. doi: 10.1186/s12875-022-01756-1.
PCR testing is considered the gold standard for SARS-CoV-2 diagnosis but its results are earliest available hours to days after testing. Rapid antigen tests represent a diagnostic tool enabling testing at the point of care. Rapid antigen tests have mostly been validated by the manufacturer or in controlled laboratory settings only. External validation at the point of care, particularly in general practice where the test is frequently used, is needed. Furthermore, it is unclear how well point of care tests are accepted by the practice staff.
In this prospective multicenter validation study in primary care, general practitioners included adult individuals presenting with symptoms suggesting COVID-19. Each patient was tested by the general practitioner, first with a nasopharyngeal swab for the point of care test (Roche SARS-CoV-2 Rapid Antigen Test) and then with a second swab for PCR testing. Using the RT-PCR result as a reference, we calculated specificity, sensitivity, positive predictive value and negative predictive value, with their 95% confidence intervals. General practitioners and medical assistants completed a survey to assess feasibility and usefulness of the point of care tests.
In 40 practices in Würzburg, Germany, 1518 patients were recruited between 12/2020 and 06/2021. The point of care test achieved a sensitivity of 78.3% and a specificity of 99.5% compared to RT-PCR. With a prevalence of 9.5%, the positive predictive value was 93.9% and the negative predictive value was 97.8%. General practitioners rated the point of care test as a helpful tool to support diagnostics in patients with signs and symptoms suggestive for infection, particularly in situations where decision on further care is needed at short notice.
The point of care test used in this study showed a sensitivity below the manufacturer's specification (Sensitivity 96.25%) in the practice but high values for specificity and high positive predictive value and negative predictive value. Although widely accepted in the practice, measures for further patient management require a sensitive interpretation of the point of care test results.
聚合酶链反应（PCR）检测被认为是 SARS-CoV-2 诊断的金标准，但检测结果最早在检测后数小时至数天才能获得。快速抗原检测代表了一种能够在护理点进行检测的诊断工具。快速抗原检测大多仅由制造商或在受控实验室环境中进行验证。需要在护理点进行外部验证，特别是在经常使用该检测的一般实践中。此外，目前尚不清楚护理点检测在实践工作人员中接受程度如何。
在这项在初级保健中进行的前瞻性多中心验证研究中，全科医生纳入出现疑似 COVID-19 症状的成年个体。每位患者均由全科医生进行检测，首先使用鼻咽拭子进行护理点检测（罗氏 SARS-CoV-2 快速抗原检测），然后使用第二个拭子进行 PCR 检测。使用 RT-PCR 结果作为参考，我们计算了特异性、敏感性、阳性预测值和阴性预测值及其 95%置信区间。全科医生和医疗助理完成了一项调查，以评估护理点检测的可行性和实用性。
在德国维尔茨堡的 40 个诊所中，于 2020 年 12 月至 2021 年 6 月期间招募了 1518 名患者。与 RT-PCR 相比，护理点检测的敏感性为 78.3%，特异性为 99.5%。在 9.5%的患病率下，阳性预测值为 93.9%，阴性预测值为 97.8%。全科医生认为护理点检测是支持具有感染迹象和症状的患者进行诊断的有用工具，特别是在需要短时间内做出进一步护理决策的情况下。
在本研究中使用的护理点检测在实践中显示出低于制造商规格（敏感性 96.25%）的敏感性，但特异性和阳性预测值及阴性预测值均较高。尽管在实践中得到广泛认可，但进一步的患者管理措施需要对护理点检测结果进行敏感解读。
