Evidence map›Paper›PMID 38421466›Full record

ArticleEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2024

Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department.

Alfredo Maldonado-Barrueco, Almudena Gutiérrez-Arroyo, Iván Bloise, María de Ceano-Vivas, Angélica Rivera-Nuñez, Rosario Torres Santos-Olmos, Dolores Montero Vega, Julio García-Rodríguez, SARS-CoV-2 working group

Abstract readEvaluation Study
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In one paragraph

Article in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Guideline
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Alfredo Maldonado-BarruecoClinical Microbiology Department, Hospital Universitario La Paz, Madrid, Spain. alfredo.maldonado@salud.madrid.org.ORCID http://orcid.org/0000-0002-1856-1725
Almudena Gutiérrez-ArroyoClinical Microbiology Department, Hospital Universitario La Paz, Madrid, Spain.
Iván BloiseClinical Microbiology Department, Hospital Universitario La Paz, Madrid, Spain.
María de Ceano-VivasPaediatric Emergency Department, Hospital Universitario La Paz, Madrid, Spain.
Angélica Rivera-NuñezAdults Emergency Department, Hospital Universitario La Paz, Madrid, Spain.
Rosario Torres Santos-OlmosAdults Emergency Department, Hospital Universitario La Paz, Madrid, Spain.
Dolores Montero VegaClinical Microbiology Department, Hospital Universitario La Paz, Madrid, Spain.
Julio García-RodríguezClinical Microbiology Department, Hospital Universitario La Paz, Madrid, Spain.
SARS-CoV-2 working group
Hospital Universitario La Paz · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesRapid 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.

methodsNasopharyngeal 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).

resultsWe 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.

conclusionsThe 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.

Indexed as

Antigens, ViralCOVID-19Emergency Service, HospitalInfluenza, HumanSARS-CoV-2Sensitivity and SpecificityAdolescentAdultAgedAged, 80 and overChildChild, PreschoolCohort StudiesCOVID-19 Serological TestingFemaleHumansAntigens, ViralAntigen testClinitestEmergency departmentInfluenza A/BPoint-of-careRespiratory infectionRT-PCRSARS-CoV-2Viruses

Identifiers

PMID38421466
OpenAlexW4392296426

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.