One Step Dengue NS1 Ag Test

Dénomination commerciale

One Step Dengue NS1 Ag Test

06936155803750

B-06936155803750

Numéro de référence/catalogue

ITP71003-TC40

GS1

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The One Step Dengue NS1 Ag Test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of dengue virus NS1 Ag in human whole blood, serum or plasma, and serves as an aid in the diagnosis of early Dengue infections. This test is a screening test, and all positives must be confirmed using an alternate test. The test is intended for healthcare professional use only. Dengue viruses are transmitted by mosquitoes and are widely distributed in tropical and subtropical areas. NS1 is a highly conserved glycoprotein present at high concentrations in the sera of dengue-infected patients during the early clinical phase and may be detected from the first day up to 9 days after onset of fever. The assay uses colloidal gold immunochromatography. Dengue NS1-specific monoclonal antibodies conjugated to colloidal gold react with dengue NS1 antigen in the specimen to form antibody-antigen gold particle complexes, which migrate along the membrane and are captured by anti-NS1 antibody to form a colored test line. The control line should always appear if the assay is performed correctly.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105099007DENGUE - RT & POC

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW011

  For professional in vitro diagnostic use only. This test is a screening test used as an aid for diagnosis and all positive results must be confirmed by an alternate method. Results should be interpreted together with clinical information and other diagnostic methods
• CW010

  Read and follow the package insert carefully before use
• CW008

  Treat all specimens as potentially infectious. Wear gloves and protective clothing when handling specimens and autoclave used devices before disposal
• CW032

  Do not use kit materials beyond their expiration dates
• CW999

  Do not interchange reagents from one kit lot to another