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篇名 盛行率對新冠抗原快速檢驗結果的影響
卷期 18:4
並列篇名 Impact of Prevalence Rate on the Rapid Antigen Test for SARS-CoV-2
作者 陳正雄陳立軒李元民
頁次 022-028
關鍵字 盛行率快速抗原檢測新冠病毒即時反逆轉錄聚合酶連鎖反應Prevalence rateRapid antigen test SARS-CoV-2Real-time reverse transcription-polymerase chain reaction
出刊日期 202210

中文摘要

目的:新冠病毒即時反轉錄聚合酶連鎖反應(RTPCR)是目前SARS-CoV-2的標準診斷方法,但其操作耗時,無法適用於所有患者。而抗原快篩(RAT)可提供便宜、簡單而快速的診斷。但確認抗原快篩之敏感性與使用策略是相當重要的。我們嘗試以回溯方式了解疾病盛行率對快速抗原快篩結果的影響。
方法:我們收集了2021年5月1日至8月31日,患者因有症狀或無症狀需緊急手術,而至急診進行COVID-19抗原快篩。當陽性結果時,立即隔離並進行RT-PCR檢驗。
結果:共有1,795位個案同時有抗原快篩和RT-PCR結果。於評估抗原快篩在疾病盛行率影響中,5月份陽性預測值(PPV)60%(敏感性:48.0%,特異性96.2%),6月份81%(敏感性:100%,特異性99.2%),7月份12%(敏感性:100%,特異性96.2%),8月份0%(敏感性:0%,特異性97.2%)。而偽陽性率分別為40%、19%、88%、100%。
結論:抗原快篩可以有效篩檢分流病患,並於高盛行率和高危險個案中進行COVID-19感染的確認。然而,抗原快篩之敏感性低於RT-PCR,基於敏感性的限制,陽性結果大多為有症狀的個案,因此仍有一定比例的偽陰性可能。當抗原快篩結果為陰性,進行臨床決策時,仍須以RT-PCR加以驗證。現在SARS-CoV-2已經發現了一些突變和變異株。將來,可能需要了解突變和變異菌株對抗原快篩的敏感性影響。

英文摘要

Purposes: The real-time reverse transcription-polymerase chain reaction (RT-PCR) of viral RNA is the gold standard for the diagnosis of SARS-CoV-2 infection. However, the operations are time-consuming and is, therefore, not suitable for every patient. In contrast, the rapid antigen test (RAT) for SARS-CoV-2 provides rapid and simple COVID-19 diagnosis at low costs. However, it is pivotal to determine the sensitivity and usage strategies of RAT. This study attempts to retrospectively explore the impact of prevalence rate of COVID-19 on RAT results.
Methods: Data from May 1 to August 31, 2021 were retrospectively collected and analyzed. These patients required surgical operations for symptomatic or non-symptomatic diseases, and had been admitted to the emergency departments where they received RAT for COVID-19. Subjects with positive results were quarantined immediately and RT-PCR tests were performed. Results: A total of 1,795 participants had both RAT and RT-PCR results. The assessment of the effect of the prevalence rate on RAT showed that the positive predictive value (PPV) was 60% in May (sensitivity: 48.0%, specificity: 96.2%), 81% in June (sensitivity: 100%, specificity: 99.2%), 12% in July (sensitivity: 100%, specificity: 96.2%), and 0% in August (sensitivity: 0%, specificity: 97.2%). The false positive rates were 40%, 19%, 88%, and 100%, respectively.
Conclusions: RAT could be used to screen the patients for triage and identify COVID-19 infection given the high prevalence rate among the high-risk population. However, RAT is less sensitive than RT-PCR. Due to the limitation of sensitivity, the majority of the results obtained from symptomatic cases were positive. Therefore, it is still possible that some of these results were false-negatives. The clinical decision-making should still be made based on confirmatory testing with RT-PCR given a negative RAT result. Currently, there are some novel mutations and variant strains of SARS-CoV-2. The impact of mutations and variant strains on the sensitivity of RAT may be explored in the future.

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