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; Zhang, Li; Ma, Di; Shi, Yingying; Wu, Jiayin; Xu, Xiaosheng; Chen, Weihong; Wu, Beiwen; Tang, Yiding; Qu, Hongping; Xie, Qing; Yang, Youwei; Liu, Jialin; Xin, Haiguang

doi:10.1128/spectrum.04542-22

Cited by 2 publications

(6 citation statements)

References 25 publications

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“…It was reported that sensitivities of DART were 78.4% for participants within 5 days after the first RT‐PCR‐positive result and 90.77% even higher within 5 days after symptom onset in a Chinese cohort. 22 And more importantly, nasopharyngeal swabs were better than oropharyngeal (throat) swab at sensitivity detection, especially in early stages of infection and in asymptomatic patients. 29 So, in our research design, nasopharyngeal swabs were mandatory, both for DART and RT‐PCR, and DART results were approved for the diagnosis of COVID‐19.…”

Section: Discussionmentioning

confidence: 98%

“…Patients were quickly admitted to hospitals if they met the criteria of moderate or severe illness according to World Health Organization (WHO) clinical progression scale of COVID‐19 infection 21 . Patients with uninfected or mild disease, including asymptomatic disease, were encouraged to stay at home, apply individual protections, and daily direct antigen rapid test (DART) for COVID‐19 22 …”

Section: Methodsmentioning

confidence: 99%

“… 21 Patients with uninfected or mild disease, including asymptomatic disease, were encouraged to stay at home, apply individual protections, and daily direct antigen rapid test (DART) for COVID‐19. 22 …”

Section: Methodsmentioning

confidence: 99%

“… 24 For patients with uninfected or mild disease, DART was performed daily at home using the COVID‐19 antigen test kits approved by NMPA, according to the manufacturer's instructions and actual accessibility of the products. 22 …”

Section: Methodsmentioning

confidence: 99%

“…24 For patients with uninfected or mild disease, DART was performed daily at home using the COVID-19 antigen test kits approved by NMPA, according to the manufacturer's instructions and actual accessibility of the products. 22 The disease history including previous treatments for B-cell lymphoma, smoking status, comorbidities of the enrolled patients were obtained from electronic medical records and following-up, as long as laboratory or imaging data. The COVID-19 antigen test or nucleic acid test result, symptoms, signs, antiviral therapies, and supportive therapies were also carefully collected and evaluated by our trained team of hematologist.…”

Section: Diagnosis Of Covid-19 and Data Recordingmentioning

confidence: 99%

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Outcomes and risk factors of SARS‐CoV‐2 omicron variant in B‐cell lymphoma patients following CD19 targeted CAR‐T therapy

Xiao,

Chen,

Zhong

et al. 2023

Cancer Medicine

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BackgroundLittle was known on infection and mortality rates, still less the risk factors of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) omicron variant in B‐cell lymphoma patients following CD19 targeted chimeric antigen receptor T cell (CAR‐T).AimsWe performed a retrospective multicenter study and analyzed the details of relapsed/refractory (R/R) B‐cell lymphoma patients who received CD19 targeted CAR‐T heretofore in five cellular immunotherapy centers in China during the omicron wave.Materials & MethodsOne hundred fifty‐four patients were enrolled in this study.ResultsAmong them, 52 patients (33.8%) were uninfected, 74 patients (48.1) had ambulatory mild disease (including nine patients of asymptomatic infection), 22 patients (14.3%) had moderate disease and six patients (3.9%) had severe disease when data collected up. Three patients with severe disease died from COVID‐19, the death rate was 1.9% for all enrolled patients, and 2.9% for infected patients. We also found that patients over 60 years old or with diabetes mellitus (DM) tend to develop severe disease (p = 0.0057 and p = 0.0497, respectively). Patients had CAR‐T infusion within 6 months also tend to have severe disease (p = 0.0011). In multivariate logistic regression model, CAR‐T infusion within 6 months (relative risk (RR) 40.92; confidence interval (CI) 4.03–415.89; p = 0.002) were associated with significantly higher risk of severe disease.ConclusionThrough this study, we conclude that the outcome for B‐cell lymphoma patients following CD19 targeted CAR‐T therapy when facing omicron infection was improved, but aggressive precautionary measures were particularly crucial for patients with high risk factors.

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Section: Discussionmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Diagnosis Of Covid-19 and Data Recordingmentioning

confidence: 99%

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Outcomes and risk factors of SARS‐CoV‐2 omicron variant in B‐cell lymphoma patients following CD19 targeted CAR‐T therapy

Xiao,

Chen,

Zhong

et al. 2023

Cancer Medicine

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Improved detection of infection with SARS-CoV-2 Omicron variants of concern in healthcare workers by a second-generation rapid antigen test

Wettengel,

Strehle,

von Lucke

et al. 2023

Microbiol Spectr

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The continuous genetic evolution of SARS-CoV-2 resulting in the immune escape variant of concern (VoC) Omicron poses a challenge to rapid and accurate diagnosis of infection, especially in high-risk groups such as healthcare workers. We performed a clinical study to determine the diagnostic accuracy and robustness of a second-generation rapid antigen test compared to a first-generation rapid antigen test with an RT-qPCR-based assay as gold standard, for early detection of infections with SARS-CoV-2 Omicron VoC. A total of 428 healthcare workers with COVID-19-associated symptoms or during routine testing participated in the study and completed a questionnaire on infection-associated symptoms, previous SARS-CoV-2 infections, and vaccination status. All participants performed a second- and first-generation rapid antigen test on the day of presentation and repeated the test 2 days later, and a diagnostic SARS-CoV-2 RT-qPCR assay was performed. qPCR-confirmed SARS-CoV-2 infections ( n = 104) with Omicron VoC (BA.2, BA.4, BA.5) were detected by the first-generation rapid antigen test with a sensitivity of 83.7% (95% CI 75.12%–90.18%), whereas the second-generation rapid antigen test performed with a sensitivity of 89.4% (95% CI 81.9%–94.6%). Increased sensitivity of the second-generation rapid antigen test led to earlier detection of SARS-CoV-2 infection, while lower test sensitivity of the first-generation rapid antigen test was compensated by repeated testing 2 days later. Moreover, direct in vitro comparison revealed a lower limit of detection for the second-generation rapid antigen test for isolates of currently circulating Omicron sub-lineages BA.5.2, BQ.1, and XBB.1. IMPORTANCE The results from this study demonstrate the usefulness of a second-generation rapid antigen test for early detection of infection with the SARS-CoV-2 Omicron variant of concern (VoC) and reveal a higher sensitivity to detect immune escape Omicron VoCs compared to a first-generation rapid antigen test (89.4% vs 83.7%) in the high-risk group of healthcare workers.

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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

Abstract: 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.

Cited by 2 publications

References 25 publications

Outcomes and risk factors of SARS‐CoV‐2 omicron variant in B‐cell lymphoma patients following CD19 targeted CAR‐T therapy

Outcomes and risk factors of SARS‐CoV‐2 omicron variant in B‐cell lymphoma patients following CD19 targeted CAR‐T therapy

Improved detection of infection with SARS-CoV-2 Omicron variants of concern in healthcare workers by a second-generation rapid antigen test

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