Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department.
Eur J Clin Microbiol Infect Dis
; 43(5): 853-861, 2024 May.
Article
em En
| MEDLINE
| ID: mdl-38421466
ABSTRACT
OBJECTIVES:
Rapid management of patients with respiratory tract infections in hospital emergency departments is one of the main objectives since the concurrent circulation of respiratory viruses following the SARS-CoV-2 pandemic. The use of new combined point-of-care antigen tests for detecting influenza A/B and SARS-CoV-2 represents an advantage in response time over the molecular tests. The objective was to evaluate the suitability of the CLINITEST® Rapid Covid-19 + Influenza Antigen test (Siemens Healthineers, Germany) (RCIA test) by measuring the sensitivity, specificity, Cohen's kappa, and cut-off values.METHODS:
Nasopharyngeal samples were collected from a randomised group of symptomatic patients of all ages at emergency department during January-February 2023. In parallel, these patients were screened for influenza A/B, and SARS-CoV-2 using RT-PCR. The Ct (cycle threshold) values were collected for positive [RT-PCR (+) /RCIA test (+)] and false negative [(RT-PCR (+) /RCIA test (-)] samples. A subanalysis was performed in the paediatric population (< 16 years-old).RESULTS:
We included 545 patients (55.8% females) with a median age of 7 years-old (IQR 1-66.5). The RCIA test showed a sensitivity of 59.7% [95%CI 46.9-67.33] for influenza A, 65.6% [95%CI 49.5-80.3] for influenza B, and 76.9% [95%CI 45.8-84.8] for SARS-CoV-2. The specificity was between 90.7%-99.7% with a moderate/high level of agreement with RT-PCR (kappa score 0.6-0.8) for the three respiratory viruses included in the RCIA test.CONCLUSIONS:
The sensitivity of the RCIA test is insufficient for screening of patients, including patients with low Ct values (Ct > 20). Despite its good specificity and Cohen's kappa value, its use as a screening test is not comparable to RT-PCR systems in the ED environment with a high number of false negative results.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Sensibilidade e Especificidade
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Serviço Hospitalar de Emergência
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Influenza Humana
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SARS-CoV-2
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COVID-19
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Antígenos Virais
Limite:
Adolescent
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Adult
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Aged
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Aged80
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article