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Erschienen in:

28.09.2021 | main topic

Evaluation of a rapid-antigen test for COVID-19 in an asymptomatic collective

A prospective study

verfasst von: Dr. Thomas von Ahnen, Martin von Ahnen, Ulrich Wirth, Hans Martin Schardey, Steffen Herdtle

Erschienen in: Wiener Medizinische Wochenschrift | Ausgabe 3-4/2022

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Summary

Background

Over the past year, there has been a significant increase in rapid antigen test (RAT) detection of SARS-CoV‑2 COVID-19. Antigen detection is usually inferior to real-time reverse transcription polymerase chain reaction (RT-PCR) in terms of sensitivity and specificity. The aim of this study was to evaluate a RAT for specificity and sensitivity in an asymptomatic collective.

Methods

The study was carried out in January 2021 at a hospital located in a district with a 7-day index and an average of more than 100 cases per 100,000 inhabitants. COVID-19 patients are treated at this hospital. All employees with symptoms typical of COVID-19 were not allowed to go to work. We used RAT by Roche® (Roche Diagnostics GmbH, D-68305 Mannheim) and RT-PCR on our employees. The testing was done voluntarily. We performed RT-PCR and RAT using two swab tubes at the same time.

Results

We could correlate 919 RAT to 919 RT-PCR tests. 12 people tested positive in RAT. All 12 tests were validated by RT-PCR. There was not one incorrect positive result in RAT. In one person COVID-19 was not detected by RAT, but then positively identified with a RT-PCR. In the group of positive RAT, the mean cycle threshold (CT) value was 19.95. Our results showed a sensitivity of 92.3%, CI (confidence interval) [0.78; 1.00] and a specificity of 100.00% CI [1.0; 1.0].

Conclusion

RAT can be an important tool for screening for SARS-CoV‑2 COVID-19 at the point of care. With low cost and resource needs, high specificity, and high specificity, RAT are performed best during the early stages of SARS-CoV‑2 COVID-19, when the viral loads are high.
Literatur
1.
Zurück zum Zitat Zhu N, Zhang D, Wang W, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382:727–33.CrossRef Zhu N, Zhang D, Wang W, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382:727–33.CrossRef
6.
Zurück zum Zitat SD Biosensor. SARS-CoV‑2 rapid antibody test package insert. 2020. SD Biosensor. SARS-CoV‑2 rapid antibody test package insert. 2020.
9.
Zurück zum Zitat Bruning AHL, Leeflang MMG, Vos J, et al. Rapid tests for influenza, respiratory syncytial virus, and other respiratory viruses: a systematic review and meta-analysis. Clin Infect Dis. 2017;65(6):1026–32.CrossRef Bruning AHL, Leeflang MMG, Vos J, et al. Rapid tests for influenza, respiratory syncytial virus, and other respiratory viruses: a systematic review and meta-analysis. Clin Infect Dis. 2017;65(6):1026–32.CrossRef
10.
Zurück zum Zitat Toptan T, Eckermann L, Pfeiffer AE, et al. Evaluation of a SARS-CoV‑2 rapid antigen test: potential to help reduce community spread? J Clin Virol. 2021;135:104713.CrossRef Toptan T, Eckermann L, Pfeiffer AE, et al. Evaluation of a SARS-CoV‑2 rapid antigen test: potential to help reduce community spread? J Clin Virol. 2021;135:104713.CrossRef
15.
Zurück zum Zitat Prince-Guerra JL, Almendares O, Nolen LD, et al. Evaluation of Abbott BinaxNOW rapid antigen test for SARS-CoV‑2 infection at two community-based testing sites—Pima County, Arizona, November 3–17, 2020. MMWR Morb Mortal Wkly Rep. 2021;70:100–5.CrossRef Prince-Guerra JL, Almendares O, Nolen LD, et al. Evaluation of Abbott BinaxNOW rapid antigen test for SARS-CoV‑2 infection at two community-based testing sites—Pima County, Arizona, November 3–17, 2020. MMWR Morb Mortal Wkly Rep. 2021;70:100–5.CrossRef
16.
Zurück zum Zitat Scohy A, Anantharajah A, Bodéus M, et al. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol. 2020;129:104455.CrossRef Scohy A, Anantharajah A, Bodéus M, et al. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol. 2020;129:104455.CrossRef
17.
Zurück zum Zitat Lauer SA, Grantz KH, Bi Q, et al. The incubation period of coronavirus disease 2019 (COVID-19) from publicly reported confirmed cases: estimation and application. Ann Intern Med. 2020;172:577–82.CrossRef Lauer SA, Grantz KH, Bi Q, et al. The incubation period of coronavirus disease 2019 (COVID-19) from publicly reported confirmed cases: estimation and application. Ann Intern Med. 2020;172:577–82.CrossRef
18.
Zurück zum Zitat Li Q, Guan X, Wu P, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med. 2020;382:1199–207.CrossRef Li Q, Guan X, Wu P, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med. 2020;382:1199–207.CrossRef
19.
Zurück zum Zitat Linton NM, Kobayashi T, Yang Y, et al. Incubation period and other epidemiological characteristics of 2019 novel coronavirus infections with right truncation: a statistical analysis of publicly available case data. J Clin Med. 2020;9:538.CrossRef Linton NM, Kobayashi T, Yang Y, et al. Incubation period and other epidemiological characteristics of 2019 novel coronavirus infections with right truncation: a statistical analysis of publicly available case data. J Clin Med. 2020;9:538.CrossRef
20.
Zurück zum Zitat WHO. Report of the WHO-China joint mission on coronavirus disease 2019 (COVID-19). 2020c. WHO. Report of the WHO-China joint mission on coronavirus disease 2019 (COVID-19). 2020c.
22.
Zurück zum Zitat Zou L, Ruan F, Huang M, et al. SARS-CoV‑2 viral load in upper respiratory specimens of infected patients. N Engl J Med. 2020;382(12):1177–9.CrossRef Zou L, Ruan F, Huang M, et al. SARS-CoV‑2 viral load in upper respiratory specimens of infected patients. N Engl J Med. 2020;382(12):1177–9.CrossRef
23.
Zurück zum Zitat Arons MM, Hatfield KM, Reddy SC, et al. Presymptomatic SARS-CoV‑2 infections and transmission in a skilled nursing facility. N Engl J Med. 2020;382:2081–90.CrossRef Arons MM, Hatfield KM, Reddy SC, et al. Presymptomatic SARS-CoV‑2 infections and transmission in a skilled nursing facility. N Engl J Med. 2020;382:2081–90.CrossRef
25.
Zurück zum Zitat Aydillo T, Gonzalez-Reiche AS, Aslam S, et al. Shedding of viable SARS-CoV‑2 after immunosuppressive therapy for cancer. N Engl J Med. 2020;383:2586–8.CrossRef Aydillo T, Gonzalez-Reiche AS, Aslam S, et al. Shedding of viable SARS-CoV‑2 after immunosuppressive therapy for cancer. N Engl J Med. 2020;383:2586–8.CrossRef
27.
Zurück zum Zitat Covid-Investigation Team. Clinical and virologic characteristics of the first 12 patients with coronavirus disease 2019 (COVID-19) in the United States. Nat Med. 2020;26:861–8.CrossRef Covid-Investigation Team. Clinical and virologic characteristics of the first 12 patients with coronavirus disease 2019 (COVID-19) in the United States. Nat Med. 2020;26:861–8.CrossRef
28.
Zurück zum Zitat He X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020b;26:672–5.CrossRef He X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020b;26:672–5.CrossRef
29.
Zurück zum Zitat Wolfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020;581:465–9.CrossRef Wolfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020;581:465–9.CrossRef
31.
Zurück zum Zitat Kimball A, Hatfield KM, Arons M, et al. Asymptomatic and presymptomatic SARS-CoV‑2 infections in residents of a long-term care skilled nursing facility—King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020;69:377–81.CrossRef Kimball A, Hatfield KM, Arons M, et al. Asymptomatic and presymptomatic SARS-CoV‑2 infections in residents of a long-term care skilled nursing facility—King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020;69:377–81.CrossRef
32.
Zurück zum Zitat Xiao AT, Tong YX, Gao C. Dynamic profile of RT-PCR findings from 301 COVID-19 patients in Wuhan, China: a descriptive study. J Clin Virol. 2020;127:104346.CrossRef Xiao AT, Tong YX, Gao C. Dynamic profile of RT-PCR findings from 301 COVID-19 patients in Wuhan, China: a descriptive study. J Clin Virol. 2020;127:104346.CrossRef
33.
Zurück zum Zitat Zheng S, Fan J, Yu F, et al. Viral load dynamics and disease severity in patients infected with SARS-CoV‑2 in Zhejiang province, China, January–March 2020: retrospective cohort study. BMJ. 2020;369:m1443.CrossRef Zheng S, Fan J, Yu F, et al. Viral load dynamics and disease severity in patients infected with SARS-CoV‑2 in Zhejiang province, China, January–March 2020: retrospective cohort study. BMJ. 2020;369:m1443.CrossRef
34.
Zurück zum Zitat Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395:1054–62.CrossRef Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395:1054–62.CrossRef
35.
Zurück zum Zitat La Scola B, Le Bideau M, Andreani J, et al. Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards. Eur J Clin Microbiol Infect Dis. 2020;39:1059–61.CrossRef La Scola B, Le Bideau M, Andreani J, et al. Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards. Eur J Clin Microbiol Infect Dis. 2020;39:1059–61.CrossRef
Metadaten
Titel
Evaluation of a rapid-antigen test for COVID-19 in an asymptomatic collective
A prospective study
verfasst von
Dr. Thomas von Ahnen
Martin von Ahnen
Ulrich Wirth
Hans Martin Schardey
Steffen Herdtle
Publikationsdatum
28.09.2021
Verlag
Springer Vienna
Erschienen in
Wiener Medizinische Wochenschrift / Ausgabe 3-4/2022
Print ISSN: 0043-5341
Elektronische ISSN: 1563-258X
DOI
https://doi.org/10.1007/s10354-021-00883-1