Rapid SARS-CoV-2 Antigen Test

Dénomination commerciale

Rapid SARS-CoV-2 Antigen Test

06936155806751

B-06936155806751

Numéro de référence/catalogue

ITP16010-TC1

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 Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in nasopharyngeal/nasal specimens collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection and is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly, and remote healthcare professional supervision can be used with appropriate clinical governance after training has been completed and verified. COVID-19 is a SARS-CoV-2 associated pneumonia that may develop into severe pneumonia, pulmonary oedema, ARDS, multiple organ failure or death. The test is based on immunochromatography for detection of SARS-CoV-2 antigen in swab-collected specimens, is visually interpreted, and provides results within 20 minutes. Gold-conjugated mouse anti-SARS-CoV-2 N-protein IgG and gold-conjugated rabbit nonspecific IgG are pre-coated on the sample pad. SARS-CoV-2 N-protein antigen, if present, reacts with the gold-conjugated antibody to form an immune complex that migrates along the test strip and is captured in the test band region to form a purplish-red band. The control band appears when the assay is valid.

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.

• W0105090501CORONAVIRUS ANTIGEN (AG) - RT & POC

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

• CW011

  For in vitro diagnostic use only. This product is for diagnosis of SARS-CoV-2 infection only; other diseases cannot be analyzed with any component of this kit. Positive results should be confirmed using an appropriate test such as RT-PCR or equivalent. Clinical diagnosis of SARS-CoV-2 infection should not be made solely based on this product, and negative results cannot rule out SARS-CoV-2 exposure or infection.
• CW010

  Read and strictly follow the instructions for use before testing. Reliability of assay results cannot be guaranteed if the instructions are not followed.
• CW008

  Strict personal protection is required. Follow good microbiological practices when handling and processing specimens. Wear disposable gloves, avoid touching the face with gloved hands, clean and disinfect contaminated areas, and decontaminate and dispose of specimens, reagents and potentially contaminated materials as infectious waste in a biohazard container.
• CW009

  Do not reuse the cassette, swab or buffer tube/test tube.