AQ+ COVID-19 Ag Rapid Test

Dénomination commerciale

AQ+ COVID-19 Ag Rapid Test

06936155806782

B-06936155806782

Numéro de référence/catalogue

ITP16042-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 AQ+ COVID-19 Ag Rapid 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; some patients may develop severe pneumonia, pulmonary oedema, ARDS, multiple organ failure or death. The AQ+ COVID-19 Ag Rapid Test is based on immunochromatography for detection of SARS-CoV-2 antigen in swab-collected specimens, is a visual qualitative test, and presents the result within 20 minutes. Gold-conjugated mouse anti-SARS-CoV-2 N-protein IgG is pre-coated on the sample pad. If SARS-CoV-2 N-protein antigen is present, it forms an immune complex with the gold-conjugated antibody, migrates along the strip, and is captured in the test band region to form a colored band. The control band appears to indicate that the test result 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

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• CW011

  For in vitro diagnostic use only. This product is for diagnosis of COVID-19 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 should not be made solely based on the test result, and negative results cannot rule out SARS-CoV-2 exposure or infection.
• CW010

  Read the instructions carefully before use and strictly follow the instructions.
• 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 other potentially contaminated materials as infectious waste in a biohazard container.
• CW009

  Do not reuse the cassette, swab or buffer tube.