INTENDED USE

To detect influenza A virus antigens and influenza B virus antigens in nasal aspirate, nasal swab, nasal discharge/nasal mucus or pharyngeal swab (to assist in the diagnosis of influenza virus infectious disease).

SUMMARY AND EXPLANATION OF THE TEST

Influenza spreads around the world in seasonal epidemics, resulting in about 3 to 5 million annual cases of severe illness and about 290,000 to 650,000 annual deaths, rising to millions in some pandemic years. (WHO News Release, 2017)

Common symptoms are chills, fever, sore throat, muscle pains, headache, coughing, weakness/fatigue and general discomfort.

Diagnosis is difficult because the initial symptoms can be similar to those caused by other infectious agents.

The influenza A virus is usually more prevalent and is associated with the most serious influenza epidemics, while influenza B infections usually present more mild symptoms.

Because the influenza virus is highly contagious, rapid diagnosis and prompt treatment can have a positive effect on public health. And the ability to distinguish between A or B antigens can help the physician to prescribe an appropriate antiviral therapy.

Administration of antiviral therapy within 48 hours of symptom onset is recommended for more rapid reduction of symptoms and to reduce viral shedding.

Capilia Flu Neo can provide rapid and accurate detection of influenza A and/or B virus antigens from symptomatic patients. No special instruments or equipment are required.

• Provides fast and reliable results
• Easy to read
• Created through the latest nanotechnology “Platinum-Gold Colloid”
• Includes an extraction buffer that is compatible with Capilia 1 series tests (Flu, Adeno, hMPV, RSV)

REAGENTS AND MATERIALS PROVIDED

• Test cartridges
• Extraction buffer (compatible with 4 different tests)
• Drip tips
• Nasal swab

REPORTING TIME

3-5 minutes

PRINCIPLE OF THE TEST

Measurement using this product is based on an immunochromatography assay using a monoclonal antibody that recognizes influenza virus antigens.

This product comprises a test plate with a carrier strip containing a sample placement area, a reagent area including a colloidal platinum-gold labeled anti-influenza A and B virus monoclonal antibody (mouse) (hereinafter referred to as “colloidal platinum-gold labeled antibody” ), a reading area [A] that fixes the anti-influenza A virus monoclonal antibody (mouse) (hereinafter referred to as “anti-influenza A virus antibody” ), a reading area [B] that fixes the anti-influenza B virus monoclonal antibody (mouse) (hereinafter referred to as “anti-influenza B virus antibody” ), and a reading area [C] that fixes the anti-mouse immunoglobulin polyclonal antibody (rabbit) (hereinafter referred to as “anti-mouse immunoglobulin antibody” ).