AQ+Rapid SARS-CoV-19/ Flu Combo Test

Dénomination commerciale

AQ+Rapid SARS-CoV-19/ Flu Combo Test

06936155808410

B-06936155808410

Numéro de référence/catalogue

ITP16050-TC5

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+ Rapid COVID-19/Flu Combo Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of antigens to SARS-CoV-2 and Influenza A and Influenza B present in human nasopharyngeal/nasal specimens. The test is used as an aid in the diagnosis of COVID-19 infection and/or Influenza A and Influenza B. COVID-19 and Influenza are both contagious respiratory illnesses caused by different viruses, and because symptoms of COVID-19, influenza and other respiratory illnesses may be similar, testing is needed to help differentiate the illness and confirm diagnosis. The device can distinguish SARS-CoV-2 viral antigens from Influenza A or Influenza B viral antigens from a single specimen using a single device, providing simple visual qualitative results within 20 minutes. The assay principle is based on gold-conjugated mouse anti-SARS-CoV-2 N-protein IgG, gold-conjugated mouse anti-influenza A nucleoprotein IgG and gold-conjugated mouse anti-influenza B nucleoprotein IgG reacting with the corresponding target antigens in the specimen to form immune complexes, which migrate along the test strip and are captured in the respective test band regions to produce visible colored bands when the target antigen concentration is above the detection limit. A control band formed by goat anti-mouse IgG must appear for the result to be 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.

• W0105090601CORONAVIRUS / INFLUENZA - RT & POC

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

• Avertissement

  For in vitro diagnostic use only. Please read and strictly follow the instructions for use. Strict personal protection is required throughout the test. This product is for diagnosis of SARS-CoV-2, Influenza A and Influenza B infection only, and clinical diagnosis should not be made based only on the product result. Negative results cannot rule out the possibility of exposure to or infection of Influenza A, Influenza B or SARS-CoV-2. Positive specimens should be confirmed using an appropriate test such as RT-PCR or equivalent. Do not use pooled specimens or specimens other than specified, such as urine or blood. Do not perform the test under conditions leading to rapid evaporation, such as >40°C and <40% RH, or close to a running fan or air conditioner.

• Consulter la notice d’utilisation

  Read the instructions for use carefully before use and follow the procedure strictly.

• Risques biologiques

  Treat all specimens and potentially contaminated materials as infectious. Follow good microbiological practices, wear disposable gloves, avoid contact of gloved hands with the face, and decontaminate and dispose of specimens, reagents and other potentially contaminated materials as infectious waste in a biohazard container.

• Ne pas réutiliser

  Do not reuse the cassette, swab or buffer tube.