四種廠牌COVID-19快篩試劑與qRT-PCR結果之比較評估

Comparison Between the Four Brands COVID-19 Antigen Rapid Test and qRT-PCR Results

張皓婷(Hao-Ting Chang) ； 溫士玄(Xei-Shi Wen) ； 潘品靜(Pin-Jing Pan) ； 湯勝輝(Sheng-Hui Tang) ； 張錦標(Jin-Biou Chang) ； 洪維彤(Wei-Tung Hung)

《中華職業醫學雜誌》 29卷2期 (2022/04) Pp. 103-110

摘要

目的：四種快篩試劑與qRT-PCR結果之比較，評估並確認其效能的各項表現。材料與方法：自110年5月16日至7月10日於台北市萬華及本院快篩站，共收納個案人數7092人（女：3500人；男：3592人）。期間使用四家不同廠牌快篩試劑（分別為Vstrip、Eternal、Abbott、Speedy），與qRT-PCR結果進行效能評估。使用MedCalc軟體統計分析，靈敏度、特異度、偽陽性率、偽陰性率、陽性似然比、陰性似然比、疾病盛行率、陽性預測值、陰性預測值的各項結果。結果：Vstrip、Eternal、Abbott、Speedy四廠牌的評估結果如下：（1）靈敏度分別為：37.5%、70.9%、79.6%、100%。（2）特異度分別為：99.4%、99.2%、99.8%、87.8%。（3）偽陽性率分別為：0.6%、0.8%、0.2%、12.2%。（4）偽陰性率分別為：62.5%、29.1%、20.4%、0.0%。（5）陽性似然比分別為：58.2、88.3、370.5、8.2。（6）陰性似然比分別為：0.6、0.3、0.2、0。（7）疾病盛行率分別為：0.7%、1.2%、6.6%、6.6%。（8）陽性預測值分別為：28.8%、52.6%、96.3%、36.6%。（9）陰性預測值分別為：99.6%、99.6%、98.6%、100%。結論：研究結果顯示Speedy廠牌靈敏度的表現較佳；Abbott廠牌則於特異度、偽陽性率、陽性似然比及陽性預測值表現上較高於其餘三家廠牌。此研究結果可做為各院使用單位之參考。

關鍵字

COVID-19 ； COVID-19快篩試劑 ； qRT-PCR

並列摘要

Purpose: This study was to evaluate the performance of four brands COVID-19 antigen rapid test, in comparison to qRT-PCR Results Materials and methods: Nasopharyngeal swabs were collected from 7092 participants (female: 3500; male:3592) at the fifth screening station of Taipei Wanhua district and Tri-Service General Hospital, between May 16 and July 10, 2021. In the period, we replaced four brands COVID-19 antigen rapid test, respectively Vstrip、Eternal、Abbott、and Speedy, in comparison to qRT-PCR results. We used MedCalc statistical analysis software to evaluate the performance of sensitivity, specificity, false positive rate, false negative rate, positive likelihood ratio, negative likelihood ratio, disease prevalence, positive predictive value, and negative predictive value. Results: The evaluation results of the four brand Vstrip、Eternal、Abbott、Speedy: (1) sensitivity: 37.5%、70.9%、79.6%、100%。(2) specificity: 99.4%、99.2%、99.8%、87.8%。(3) false positive rate: 0.6%、0.8%、0.2%、12.2%。(4) false negative rate: 62.5%、29.1%、 20.4%、0.0%。(5) positive likelihood ratio: 58.2、88.3、370.5、8.2。(6) negative likelihood ratio: 0.6、0.3、0.2、0。(7) disease prevalence: 0.7%、1.2%、6.6%、6.6%。(8) positive predictive value: 28.8%、52.6%、96.3%、36.6%。(9) negative predictive value: 99.6%、99.6%、 98.6%、100%。 Conclusion: In our study, the Speedy had the best sensitivity performance; the Abbott had the better performance of specificity, false positive rate, positive likelihood ratio and positive predictive value than the other three brands. In conclusion, our study can be used as a reference for each hospital.

並列關鍵字

COVID-19 ； COVID-19 rapid antigen screening test ； qRT-PCR