Emergency Medicine Program, Eastern Health, Melbourne, Victoria, Australia.
Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.
BMJ Open. 2022 Dec 29;12(12):e065568. doi: 10.1136/bmjopen-2022-065568.
To determine the negative predictive value (NPV) of the FebriDx point-of-care host response device in patients presenting with symptoms suggestive of COVID-19 infection in a mostly immunised Australian emergency department (ED) population during the late 2021 phase of the COVID-19 pandemic.
Observational diagnostic accuracy study comparing FebriDx point-of-care test to SARS-CoV-2 PCR.
An ED in Melbourne, Australia, with 63 000 annual presentations in 2021.
Patients aged 16 and over who met the Victorian Department of Health case definition for suspected COVID-19 infection PCR testing. Patients meeting any of the following criteria were excluded: <16 years of age; acute respiratory symptom(s) with onset>14 days prior to testing; current immunosuppressive or interferon therapy; live immunisation within the last 30 days; fever lasting>7 days; antibiotic or antiviral use in the preceding 14 days; experience of major trauma, major surgical intervention or severe burns within the last 30 days.
COVID-19 PCR results (detected, not detected) and FebriDx results (bacterial positive, viral negative, viral positive).
94 participants were enrolled (female: 46; male: 48), 34% of participants (tested positive for COVID-19 according to PCR results, with a background incidence among all adult ED attenders of 2.5%. The sensitivity of FebriDx for detection of COVID-19 was 56% (95% CI 40% to 100%) and specificity was 92% (95% CI 84% to 100%). For the population tested, this resulted in an NPV of 80% (95% CI 71% to 100%) and a positive predictive value of 78% (95% CI 60% to 100%).
In the context of a population with low COVID-19 infection rates, an evolved variant of COVID-19 and a very high community COVID-19 vaccination rate, FebriDx demonstrated reduced sensitivity and NPV relative to results from earlier international tests. These contextual factors should be considered during any attempt to generalise the current results.
ACTRN12620001029987 (Australian Clinical Trials).
在 COVID-19 大流行的 2021 年末，在澳大利亚一家主要接种疫苗的急诊科，确定 FebriDx 即时护理宿主反应设备在出现 COVID-19 感染症状的患者中的阴性预测值（NPV）。
比较 FebriDx 即时检测与 SARS-CoV-2 PCR 的观察性诊断准确性研究。
澳大利亚墨尔本的一家急诊科，2021 年每年就诊 63000 次。
年龄在 16 岁及以上、符合维多利亚州卫生部 COVID-19 疑似 PCR 检测病例定义的患者。符合以下任何标准的患者被排除在外：<16 岁；症状出现>14 天；目前正在接受免疫抑制或干扰素治疗；在过去 30 天内接受过活疫苗接种；发热持续>7 天；在过去 14 天内使用抗生素或抗病毒药物；在过去 30 天内经历过重大创伤、重大手术干预或严重烧伤。
COVID-19 PCR 结果（检测到，未检测到）和 FebriDx 结果（细菌阳性，病毒阴性，病毒阳性）。
共纳入 94 名参与者（女性：46 人；男性：48 人），34%的参与者（根据 PCR 结果检测为 COVID-19 阳性，所有成年急诊科就诊者的背景发病率为 2.5%。FebriDx 检测 COVID-19 的敏感性为 56%（95%CI 40%至 100%），特异性为 92%（95%CI 84%至 100%）。对于所检测的人群，这导致阴性预测值为 80%（95%CI 71%至 100%）和阳性预测值为 78%（95%CI 60%至 100%）。
在 COVID-19 感染率较低、COVID-19 变异株不断进化且社区 COVID-19 疫苗接种率非常高的情况下，与早期国际检测结果相比，FebriDx 的敏感性和 NPV 降低。在试图推广当前结果时，应考虑这些背景因素。
ACTRN12620001029987（澳大利亚临床试验）。
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