Diagnostic performance of a novel digital immunoassay (RapidTesta SARS-CoV-2): A prospective observational study with nasopharyngeal samples.
J Infect Chemother
; 28(1): 78-81, 2022 Jan.
Article
em En
| MEDLINE
| ID: mdl-34736814
ABSTRACT
INTRODUCTION:
Digital immunoassays are generally regarded as superior tests for the detection of infectious disease pathogens, but there have been insufficient data concerning SARS-CoV-2 immunoassays.METHODS:
We prospectively evaluated a novel digital immunoassay (RapidTesta SARS-CoV-2). Two nasopharyngeal samples were simultaneously collected for antigen tests and Real-time RT-PCR.RESULTS:
During the study period, 1127 nasopharyngeal samples (symptomatic patients 802, asymptomatic patients 325) were evaluated. For digital immunoassay antigen tests, the sensitivity was 78.3% (95% CI 67.3%-87.1%) and the specificity was 97.6% (95% CI 96.5%-98.5%). When technicians visually analyzed the antigen test results, the sensitivity was 71.6% (95% CI 59.9%-81.5%) and the specificity was 99.2% (95% CI 98.5%-99.7%). Among symptomatic patients, the sensitivity was 89.4% (95% CI; 76.9%-96.5%) with digital immunoassay antigen tests, and 85.1% (95% CI; 71.7%-93.8%) with visually analyzed the antigen test, respectively.CONCLUSIONS:
The sensitivity of digital immunoassay antigen tests was superior to that of visually analyzed antigen tests, but the rate of false-positive results increased with the introduction of a digital immunoassay device.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
SARS-CoV-2
/
COVID-19
Tipo de estudo:
Diagnostic_studies
/
Observational_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article