Evaluation of a rapid-antigen test for COVID-19 in an asymptomatic collective : A prospective study.
Evaluierung eines Antigen-Schnelltests auf COVID-19 in einer asymptomatischen Kohorte : Eine prospektive Studie.
COVID-19
Mass screening
Point-of-care testing
Rapid antigen tests
Real-time reverse transcription polymerase chain reaction
Journal
Wiener medizinische Wochenschrift (1946)
ISSN: 1563-258X
Titre abrégé: Wien Med Wochenschr
Pays: Austria
ID NLM: 8708475
Informations de publication
Date de publication:
Mar 2022
Mar 2022
Historique:
received:
02
05
2021
accepted:
19
08
2021
pubmed:
29
9
2021
medline:
11
3
2022
entrez:
28
9
2021
Statut:
ppublish
Résumé
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. 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. 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]. 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.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 34581966
doi: 10.1007/s10354-021-00883-1
pii: 10.1007/s10354-021-00883-1
pmc: PMC8476981
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
70-73Informations de copyright
© 2021. Springer-Verlag GmbH Austria, ein Teil von Springer Nature.
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