Evaluation of the Rapid Antigen Detection Test for Diagnosing SARS-CoV-2 during the COVID-19 Pandemic: Experience from a Centralized Isolation Site in Shanghai, China.
Evaluation of the Rapid Antigen Detection Test for Diagnosing SARS-CoV-2 during the COVID-19 Pandemic: Experience from a Centralized Isolation Site in Shanghai, China.
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DOI：
10.1128/spectrum.04542-22
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发表时间：
2023-02-14
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
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作者：
Rapid and reliable diagnosis is important for the management of individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The rapid antigen detection test (RADT) is a rapid, inexpensive, and easy method. Several studies have reported that RADTs performed well in many countries; however, very few studies have been reported in China. In this study, we assessed the performance of the RADT (Ediagnosis COVID-19 antigen test kit). This study was conducted in a centralized isolation site in Shanghai and enrolled 716 patients with COVID-19 and 203 noninfected participants. Nasopharyngeal swabs from all participants were collected on the same day and tested using the RADT and real-time reverse transcription-PCR (RT-PCR). The performance of the RADT was evaluated in different scenarios, such as threshold cycle (CT) values, symptomatic phase, and symptoms on the day of testing. The results demonstrated that the sensitivity for patients with CT values lower than 20 was 96.55% (95% confidence interval [CI], 87.05 to 99.4). The sensitivities were 78.4% (95% CI, 69.96 to 85.05) for participants within 5 days after the first RT-PCR-positive result and 90.77% (95% CI, 80.34 to 96.19) within 5 days after symptom onset. Moreover, the sensitivity of the RADT was more than 80% for patients with symptoms on the day of testing, including fever (89.29%), cough (86.84%), stuffy nose (92.59%), runny nose (92%), sore throat (81.25%), and muscle pain (80.77%), especially for those with upper respiratory tract symptoms. The specificity of the RADT was good in all scenarios. During the SARS-CoV-2 epidemic, Ediagnosis performed excellently in individuals with a higher viral load (evidenced by lower CT values), individuals in the early symptomatic phase, and especially those with upper respiratory tract symptoms. IMPORTANCE RADTs have demonstrated excellent performance in many counties for screening SARS-CoV-2 infection, but very few studies have been conducted in China. The performance of RADTs is largely related to different real-life scenarios. In our study, the performance of the RADT was evaluated in different scenarios, such as CT values, symptomatic phase, and symptoms on the day of testing. The results demonstrated that Ediagnosis (an RADT made in China) performed excellently for individuals with a higher viral load (evidenced by lower CT values), individuals in the early symptomatic phase, and especially those with upper respiratory tract symptoms.
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影响因子：
19
作者：
Singanayagam, Anika;Patel, Monika;Gopal, Robin
通讯作者：
Gopal, Robin
影响因子：
64.8
作者：
通讯作者：
--
影响因子：
3.7
作者：
Ngo Nsoga MT;Kronig I;Perez Rodriguez FJ;Sattonnet-Roche P;Da Silva D;Helbling J;Sacks JA;de Vos M;Boehm E;Gayet-Ageron A;Berger A;Jacquerioz-Bausch F;Chappuis F;Kaiser L;Schibler M;Renzoni A;Eckerle I
通讯作者：
Eckerle I
DOI：
10.2807/1560-7917.es.2021.26.50.2101147
发表时间：
2021-12
期刊：
Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin
影响因子：
--
作者：
Brandal LT;MacDonald E;Veneti L;Ravlo T;Lange H;Naseer U;Feruglio S;Bragstad K;Hungnes O;Ødeskaug LE;Hagen F;Hanch-Hansen KE;Lind A;Watle SV;Taxt AM;Johansen M;Vold L;Aavitsland P;Nygård K;Madslien EH
通讯作者：
Madslien EH
影响因子：
4.4
作者：
Ahmad Malik J;Ahmed S;Shinde M;Almermesh MHS;Alghamdi S;Hussain A;Anwar S
通讯作者：
Anwar S