Influenza A+B rapid test for professional use
The Influenza A+B rapid test is a qualitative immunochromatographic assay for detecting influenza A and B virus antigens in nasopharyngeal swab, throat swab or nasal aspirate specimens. It is intended for professional in vitro diagnostic use.
Who is the test intended for?
The test is intended for professional use and has not been tested for home use.
Which specimen types can be used?
According to the instructions for use, the test can be used with nasopharyngeal swabs, throat swabs and nasal aspirates. Specimen collection and testing must follow the supplied instructions.
Specimen collection and test procedure
- Allow the test cassette, specimen, buffer and controls to reach room temperature before testing.
- Collect the specimen using the appropriate method and extract it in the buffer.
- Add three drops of the extracted specimen to the specimen well.
- Read the result at the specified time.
When should the result be read?
Read the result at 15 minutes. Do not interpret the result after 20 minutes.
How is the result interpreted?
- Influenza A positive: control line C and test line A appear.
- Influenza B positive: control line C and test line B appear.
- Influenza A and B positive: control line C and both test lines A and B appear.
- Negative: only control line C appears.
- Invalid: control line C does not appear. Repeat the test with a new cassette.
Does a negative result rule out influenza?
No. A negative result does not rule out influenza. A confirmatory method should be used when necessary.
Performance stated in the IFU
- Nasopharyngeal swabs: relative sensitivity 99.0% for influenza A and 97.7% for influenza B; relative specificity 99.9% and 99.6%.
- Throat swabs: relative sensitivity 95.1% for influenza A and 94.2% for influenza B; relative specificity 99.6% and 97.8%.
- Nasal aspirates: relative sensitivity 100% for influenza A and 97.9% for influenza B; relative specificity 99.3% and 98.4%.
Performance figures apply to the specimen types and comparator methods stated in the IFU. Results must be assessed together with other available clinical information.
Kit contents
- 20 individually sealed test cassettes
- 20 extraction tubes
- 20 dropper tips
- 20 sterile swabs
- extraction buffer
- workstation
- instructions for use
Storage and important limitations
- Store at 2–30 °C. Do not freeze.
- Do not use after the expiry date or if the foil pouch is damaged.
- For single use only.
- The test differentiates influenza A and B but does not identify influenza A subtypes.
- A positive result does not rule out co-infection with other pathogens.
Manufacturer: Hangzhou AllTest Biotech Co., Ltd.
EU authorised representative: MedNet EC-REP GmbH.
Importer: Abcell Oy.
Read the English instructions for use (IFU, revision 2023-07-12).
Order the Influenza A+B rapid test for professional use and always follow the product instructions.
