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COVID-19 : How to use the test

June 5, 2020

 

Products Range

New product:

COVID-19
Ag Respi-Strip

BL-RED Range

Resist Range

IMP - NEW

OXA-23

Oxa-48

KPC

RESIST-3 O.O.K.

RESIST-3 O.K.N.

RESIST-4 O.K.N.V.

RESIST-5

Immunochromatographic Range

Pathogens detection

40/41 Adenovirus

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Rotavirus & 40/41 Adenovirus

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Helicobacter pylori

Influenza A & B viruses

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Respiratory Adenovirus

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Molecular Range

Pseudomonas aeruginosa

Scientific partners

VHFMoDrad

INNPAPER

PARADIS (Biowin)

AquaVir (FP7)

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Euroleish (H2020-MSCA-ITN)

ebolaMoDRAD (IMI-2)

 

Products  >  Human-Field  >  Covid-19  >  Science

Sars Cov- - Science

• COVID-19 Response in Sub-Saharan Low-Resource Setting: Healthcare Soldiers Need Bullets

Denis Mukwege, Guy-Bernard Cadière, Olivier Vandenberg

Am. J. Trop. Med. Hyg., 00(0), 2020, pp. 1-2

Article

 

 

• Evaluation of a rapid diagnostic assay for detection of SARS CoV-2 antigen in nasopharyngeal swab

Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, Le Goff J, Delaugerre C

J. Clin. Microbiol. 2020 May 13 00977-20.

https://jcm.asm.org/content/jcm/early/2020/05/11/JCM.00977-20.full.pdf

Article

 

• Development and potential usefulness of the COVID-19 Ag Respi-Strip diagnostic assay in a pandemic context.

Mertens P, De Vos N, Martiny D, Jassoy C, Mirazimi A, Cuypers L, Van Den Wijngaert S, Monteil V, Melin P, Stoffels K, Yin N, Mileto D, Delaunoy S, Magein H, Lagrou K, Bouzet J,  Serrano G,  Wautier M,  Leclipteux T,  Van  Ranst M and Vandenberg O

Front. Med., 08 May 2020.

Abstract

Introduction:
COVID-19 Ag Respi-Strip, an immunochromatographic (ICT) assay for the rapid detection of SARS-CoV-2 antigen on nasopharyngeal specimen, has been developed to identify positive COVID-19 patients allowing prompt clinical and quarantine decisions. In this Original Research article, we describe the conception, the analytical and clinical performances as well as the risk management of implementing the COVID-19 Ag Respi-Strip in a diagnostic decision algorithm. Materials and Methods: Development of the COVID-19 Ag Respi-Strip resulted in a ready-to-use ICT assay based on a membrane technology with colloidal gold nanoparticles using monoclonal antibodies directed against the SARS-CoV and SARS-CoV-2 highly conserved nucleoprotein antigen. Four hundred observations were recorded for the analytical performance study and thirty tests were analysed for the cross-reactivity study. The clinical performance study  was  performed  in  a  retrospective  multi-centric  evaluation  on  aliquots  of  328 nasopharyngeal samples. COVID-19 Ag Respi-Strip results were compared with qRT-PCR as golden standard for COVID-19 diagnostics.

Results:
In the analytical performance study, the reproducibility showed a between-observer disagreement of 1.7%, a robustness of 98%, an overall satisfying user friendliness and no cross-reactivity with other virus-infected nasopharyngeal samples. In the clinical performance study performed in three different clinical laboratories we found an overall sensitivity and specificity of 57.6% and 99.5% respectively with an accuracy of 82.6%. The cut-off of the assay was found at  Ct<22.  User-friendliness  analysis  and  risk  management  assessment  through  Ishikawa diagram  demonstrate  that  COVID-19  Ag  Respi-Strip  may  be  implemented  in  clinical laboratories according to biosafety recommendations.

Conclusion:
The  COVID-19  Ag  Respi-Strip  represents  a  promising  rapid  SARS-CoV-2 antigen assay for the first-line diagnosis of COVID-19 in 15 minutes. Its role in the proposed diagnostic algorithm is complementary to the currently-used molecular techniques.

https://www.frontiersin.org/articles/10.3389/fmed.2020.00225/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Medicine&id=551560

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