AQ+ COVID-19 Ag Rapid Test

Trade name

AQ+ COVID-19 Ag Rapid Test

UDI-DI code

06936155806805

Basic UDI-DI

B-06936155806805

Reference / catalog number

ITP16042-TC25-

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105090501CORONAVIRUS ANTIGEN (AG) - RT & POC

5 warnings recorded — scroll inside the panel to see all entries.

• 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.; Biological risks: 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.
• CW007

  Do not use the swab if the package is damaged or the seal is broken, and do not use the test cassette if the foil pouch is damaged or the seal is broken.
• CW032

  Do not use the swab if the package is damaged or the seal is broken, and do not use the test cassette if the foil pouch is damaged or the seal is broken.

No certificate specifically references this device's Basic UDI-DI.