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Evaluation of performance of two SARS-CoV-2 Rapid whole-blood finger-stick IgM-IgGCombined Antibody Tests
Thierry Prazuck; Mathilda Colin; Susanna Giache; Camelia Gubavu; Aymeric Seve; Vincent Rzepecki; Marie Chevereau-Choquet; Catherine Kiani; Victor Rodi; Elsa Lyonnet; Laura Courtellemont; Jerome Guinard; Gilles Pialoux; Laurent Hocqueloux.
Afiliación
  • Thierry Prazuck; CHR Orleans, Department of infectious and tropical diseases
  • Mathilda Colin; Department of infectious and tropical diseases, CHR Orleans
  • Susanna Giache; Department of infectious and tropical diseases, CHR Orleans
  • Camelia Gubavu; Department of infectious and tropical diseases, CHR Orleans
  • Aymeric Seve; Department of infectious and tropical diseases, CHR Orleans
  • Vincent Rzepecki; Department of infectious and tropical diseases, CHR Orleans
  • Marie Chevereau-Choquet; Department of infectious and tropical diseases
  • Catherine Kiani; Department of infectious and tropical diseases, CHR Orleans
  • Victor Rodi; Department of infectious and tropical diseases, CHR Orleans
  • Elsa Lyonnet; Department of infectious and tropical diseases, CHR Orleans
  • Laura Courtellemont; Department of virology, CHR Orleans
  • Jerome Guinard; Department of virology, CHR Orleans
  • Gilles Pialoux; Department of infectious diseases, Hopital Tenon
  • Laurent Hocqueloux; Department of infectious and tropical diseases, CHR Orleans
Preprint en En | PREPRINT-MEDRXIV | ID: ppmedrxiv-20112888
ABSTRACT
BackgroundThe SARS-CoV-2 virus is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease). In response to the growing COVID-19 pandemic, Rapid Diagnostic Tests (RDTs) have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a real-life study to evaluate the performance of two RDTs, COVID-PRESTO(R) and COVID-DUO(R), compared to the gold standard, RT-PCR. MethodsRT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orleans, France). Fingertip whole blood samples taken at different time points after onset of the disease were tested with RDTs. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated. ResultsAmong 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with RDTs were all negative for these patients, indicating a specificity of 100% for both RDTs. In the RT-PCR positive subgroup (n=238), 133 patients were tested with COVID-PRESTO(R) and 129 patients were tested with COVID-DUO(R) (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO(R) test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO(R) test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days). ConclusionCOVID-PRESTO(R) and DUO(R) RDTs turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with capillary blood sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.
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Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Diagnostic_studies / Experimental_studies Idioma: En Año: 2020 Tipo del documento: Preprint
Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Diagnostic_studies / Experimental_studies Idioma: En Año: 2020 Tipo del documento: Preprint