A prospective clinical evaluation of the diagnostic accuracy of the SARS-CoV-2 rapid antigen test using anterior nasal samples

Akashi, Yusaku; Horie, Michiko; Takeuchi, Yuto; Togashi, K; Adachi, Yuki; Ueda, Atsuo; Notake, Shigeyuki; Nakamura, Koji; Terada, Norihiko; Kurihara, Yoko; Kiyasu, Yoshihiko; Suzuki, Hiromichi

doi:10.1016/j.jiac.2022.02.016

Cited by 8 publications

(7 citation statements)

References 20 publications

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“…In this study, the results of NS specimens with the FUJIFILM COVID-19 Ag test exhibited an overall sensitivity of >90% for samples with Ct values <30, which is more sensitive than other antigen tests [ 21 , 23 ], and a specificity of 100%. Simulation studies suggest that highly sensitive antigen tests can reduce the number of tests required, shorten the isolation period of patients, and accelerate their return to society [ 24 ].…”

Section: Discussionmentioning

confidence: 60%

Prospective Clinical Evaluation of the Diagnostic Accuracy of a Highly Sensitive Rapid Antigen Test Using Silver Amplification Technology for Emerging SARS-CoV-2 Variants

Obata

Miyakawa²,

Takei³

et al. 2022

Biomedicines

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The COVID-19 pandemic caused by SARS-CoV-2 remains a serious health concern worldwide due to outbreaks of SARS-CoV-2 variants that can escape vaccine-acquired immunity and infect and transmit more efficiently. Therefore, an appropriate testing method for COVID-19 is essential for effective infection control and the prevention of local outbreaks. Compared to reverse-transcription polymerase chain reaction (RT-PCR) tests, antigen tests are used for simple point-of-care testing, enabling the identification of viral infections. In this study, we tested the clinical usefulness of the FUJIFILM COVID-19 Ag test, an antigen test based on silver amplification and immunochromatographic technology. The FUJIFILM COVID-19 Ag test was shown to detect a lower viral concentration as compared to other conventional kits without significant performance loss in detecting prevalent SARS-CoV-2 variants. We tested nasopharyngeal and nasal swabs from a single patient during two different epidemic periods dominated by various SARS-CoV-2 variants. We observed that the sensitivity of the FUJIFILM COVID-19 Ag test was 95.7% and 85.7% in nasopharyngeal and nasal swabs, respectively. These results suggest that the FUJIFILM COVID-19 Ag test is highly sensitive and applicable when RT-PCR testing is unavailable. Furthermore, these results indicate that high-frequency testing using nasal swab specimens may be a valuable screening strategy.

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Section: Discussionmentioning

confidence: 60%

Prospective Clinical Evaluation of the Diagnostic Accuracy of a Highly Sensitive Rapid Antigen Test Using Silver Amplification Technology for Emerging SARS-CoV-2 Variants

Obata

Miyakawa²,

Takei³

et al. 2022

Biomedicines

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“…Among the 49 studies on nasal swabs containing 79,073 samples [ [2] , [3] , [4] , 6 , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] ], all of them were published between 2021 and 2022, and twenty-one studies were conducted in the USA [ 12 , 14 , 15 , 18 , 21 , 22 , [25] , [26] , [27] , [32] , [33] , [34] , [35] , 39 , 44 , 45 , [47] ...…”

Section: Resultsmentioning

confidence: 99%

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

Xie

Zheng

Wang

et al. 2023

Travel Medicine and Infectious Disease

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“…After searching electronic databases such as PubMed, Embase, Web of Science, Google Scholar, EBSCO, and the Cochrane library, recorded before Dec 1st, 2021 using terms of Covid 19 antibody test, Covid 19 antigen test, SARSCoV-2 antibody test, SARS-CoV-2 antigen test, or rapid SARS-CoV-2 test, 26 ( 18 , 23 – 47 )studies were included for meta-analysis. The specific process of publication screening and filtration was shown in the flow diagram ( Fig.…”

Section: Resultsmentioning

confidence: 99%

Detection of Antibody versus Antigen, Optimal Option of Different Serological Assays Based Tests for COVID-19 Diagnosis: A Meta-Analysis

Fu¹,

Sun²,

Zhu³

2023

ijph

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Background: In this study, the diagnostic efficacy of antigen test and antibody test were assessed. Additionally, the difference of sensitivity, specificity, and diagnostic odds ratio were compared concerning efficacy of antibody test versus antigen test for Corona Virus Disease 2019 (COVID-19) diagnosis. Methods: Online databases were searched for full-text publications and STATA software was used for data pooling and analysis before Sep 1st, 2022. Forrest plot was used to show the pooled sensitivity, specificity and diagnostic odds ratio. Combined receiver operating characteristic (ROC) curve was used to show the area of under curve of complex data. Results: Overall, 25 studies were included. The sensitivity (0.68, 95% CI: 0.53-0.80) and specificity (0.99, 95% CI: 0.98-0.99) in antibody or antigen was calculated. The time point of test lead to heterogeneity. The area under curve (AUC) was 0.98 (95% CI: 0.96-0.99), and the diagnostic odds ratio (DOR) was 299.54 (95% CI: 135.61-661.64). Subgroup analysis indicated antibody test with sensitivity (0.59, 95% CI: 0.44-0.73) and specificity (0.98, 95% CI: 0.95-0.99) and antigen test with sensitivity of 0.77 (95% CI: 0.53-0.91) and specificity of 0.99 (95% CI: 0.98-1.00). Higher AUC and DOR were proved in antigen test. Conclusion: The present study compared the efficacy of antibody test versus antigen test for COVID-19 diagnosis. Better diagnostic efficacy, lower heterogeneity, and less publication bias of rapid antigen testing was suggested in this study. This study would help us to make better strategy about choosing rapid and reliable testing method in diagnosis of the COVID-19 disease.

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A prospective clinical evaluation of the diagnostic accuracy of the SARS-CoV-2 rapid antigen test using anterior nasal samples

Cited by 8 publications

References 20 publications

Prospective Clinical Evaluation of the Diagnostic Accuracy of a Highly Sensitive Rapid Antigen Test Using Silver Amplification Technology for Emerging SARS-CoV-2 Variants

Prospective Clinical Evaluation of the Diagnostic Accuracy of a Highly Sensitive Rapid Antigen Test Using Silver Amplification Technology for Emerging SARS-CoV-2 Variants

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

Detection of Antibody versus Antigen, Optimal Option of Different Serological Assays Based Tests for COVID-19 Diagnosis: A Meta-Analysis

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