tetano
Editor, Senior Moderator
Microbiol Spectr
. 2023 Jan 19;e0454222.
doi: 10.1128/spectrum.04542-22. Online ahead of print.
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
Xu Zhong[SUP] #[/SUP][SUP] 1 2 [/SUP], Li Zhang[SUP] #[/SUP][SUP] 3 [/SUP], Di Ma[SUP] #[/SUP][SUP] 4 [/SUP], Yingying Shi[SUP] 5 [/SUP], Jiayin Wu[SUP] 6 [/SUP], Xiaosheng Xu[SUP] 7 [/SUP], Weihong Chen[SUP] 8 [/SUP], Beiwen Wu[SUP] 9 [/SUP], Yiding Tang[SUP] 3 [/SUP], Hongping Qu[SUP] 3 [/SUP], Qing Xie[SUP] 10 [/SUP], Yi Yang[SUP] 11 [/SUP], Jialin Liu[SUP] 3 [/SUP], Haiguang Xin[SUP] 10 [/SUP]
Affiliations
Abstract
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 (C[SUB]T[/SUB]) values, symptomatic phase, and symptoms on the day of testing. The results demonstrated that the sensitivity for patients with C[SUB]T[/SUB] 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 C[SUB]T[/SUB] 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 C[SUB]T[/SUB] 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 C[SUB]T[/SUB] values), individuals in the early symptomatic phase, and especially those with upper respiratory tract symptoms.
Keywords: SARS-CoV-2; diagnostic performance; nasopharyngeal swabs; rapid antigen detection test; upper respiratory tract symptoms.
. 2023 Jan 19;e0454222.
doi: 10.1128/spectrum.04542-22. Online ahead of print.
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
Xu Zhong[SUP] #[/SUP][SUP] 1 2 [/SUP], Li Zhang[SUP] #[/SUP][SUP] 3 [/SUP], Di Ma[SUP] #[/SUP][SUP] 4 [/SUP], Yingying Shi[SUP] 5 [/SUP], Jiayin Wu[SUP] 6 [/SUP], Xiaosheng Xu[SUP] 7 [/SUP], Weihong Chen[SUP] 8 [/SUP], Beiwen Wu[SUP] 9 [/SUP], Yiding Tang[SUP] 3 [/SUP], Hongping Qu[SUP] 3 [/SUP], Qing Xie[SUP] 10 [/SUP], Yi Yang[SUP] 11 [/SUP], Jialin Liu[SUP] 3 [/SUP], Haiguang Xin[SUP] 10 [/SUP]
Affiliations
- PMID: 36655994
- DOI: 10.1128/spectrum.04542-22
Abstract
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 (C[SUB]T[/SUB]) values, symptomatic phase, and symptoms on the day of testing. The results demonstrated that the sensitivity for patients with C[SUB]T[/SUB] 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 C[SUB]T[/SUB] 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 C[SUB]T[/SUB] 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 C[SUB]T[/SUB] values), individuals in the early symptomatic phase, and especially those with upper respiratory tract symptoms.
Keywords: SARS-CoV-2; diagnostic performance; nasopharyngeal swabs; rapid antigen detection test; upper respiratory tract symptoms.