Rapid flu test

for antigensinfluenza Ainfluenza B

Product overview
The Influenza A+B Rapid Test Device is a cassette-format chromatographic immunoassay for qualitative detection of Influenza A and Influenza B antigens in nasal swab, throat swab or nasal aspirate specimens. It delivers results within 15 minutes and is intended to assist rapid differential diagnosis of Influenza A and B infections in clinical settings.

Intended use
The device qualitatively detects Influenza A and/or Influenza B antigens in nasal swab, throat swab or nasal aspirate specimens. The test employs specific antibodies for Influenza A and B to provide separate detection lines for each virus and yields results within 15 minutes.

Specimen collection

• Nasopharyngeal swab: insert a sterile swab into the nasal cavity and rotate along the turbinate several times to collect sample.
• Pharyngeal (throat) swab: insert a sterile swab into the pharynx and swab the posterior pharyngeal wall and palatine tonsils, avoiding saliva contamination.
• Nasopharyngeal aspirate: use an aspiration catheter and trap to collect nasal aspirate; dip a sterile swab into the aspirate to transfer specimen to the swab.

Principle and format
The test is a cassette-format rapid chromatographic immunoassay using colloidal gold-labeled antibodies to separately detect Influenza A and Influenza B antigens.

Components

• Individually packaged test cassettes
• Extraction reagent
• Extraction tubes
• Sterile swabs
• Package insert

Performance characteristics

• Positive coincidence rate: 100%
• Negative coincidence rate: 100%
• Analytical sensitivity: Influenza A approximately 1.3×10^4 TCID50; Influenza B approximately 9.2×10^4 TCID50
• Time to result: within 15 minutes

Storage and stability
Store at 4-30°C. Shelf life: 24 months.

Operating steps (summary)
Collect the appropriate specimen (nasal/throat swab or nasal aspirate), process the specimen with extraction reagent in the extraction tube, apply the processed specimen to the cassette sample well, and read the result within the specified time (within 15 minutes).

Technical specifications

• Product: Medical device — Influenza A/B rapid diagnostic test kit
• Commercial name: Influenza A+B Rapid Test Device
• Specimen: nasal swab / throat swab / nasal aspirate
• Format: cassette
• Method: colloidal gold immunochromatography
• Components: individually packed test devices, extraction reagent, extraction tubes, sterile swabs, package insert
• Dimension (strip): 3 mm, 4 mm
• Storage temperature: 4-30°C
• Validity: 24 months
• Positive coincidence rate: 100%
• Negative coincidence rate: 100%
• Analytical sensitivity: Influenza A ~1.3×10^4 TCID50; Influenza B ~9.2×10^4 TCID50
• Time to result: within 15 minutes
• Brand / Manufacturer: HWTAI