Influenza A and B Rapid Test

Intended Use

Influenza A and B Rapid Test is an in vitro immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal/nasopharyngeal swabs and nasal washes/aspirates of humans. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Influenza A and B Rapid Test is not intended for the detection of influenza C viral antigens. Negative results do not preclude influenza A or B viral infections and should be confirmed via cell culture or molecular assay. The Influenza A/B Rapid Test Device is for professional use only.

Introduction

Influenza virus can be distinguished into influenza virus A, B and C on the basis of antigenic differences between their nucleoprotein and matrix proteins. For types A and B, the antigenic variation of hemagglutinin and neuraminidase is responsible for the emergence of new strains, while type C is antigenically stable1. Type A influenza viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B influenza infections are usually milder2. Influenza due to type C species is rare compared to types A or B3.

Who is most at risk?

Pregnant women at any stage of pregnancy

Children younger than 5 years

People older than 65 year

Materials

● Test Cassette: Each foil pouched Cassette has two distinct test lines of monoclonal antibodies specific to influenza A and B viral antigens respectively, and a control line of anti-species antibody.

● FLU Assay Buffer: Detergent, tris, sodium chloride, blocking reagent and 0.1% sodium azide as preservative.

● Extraction Tube: Tubes for sample processing and sample delivery into Cassettes.

● Nozzle with Filter: Tube tips to filter sample when delivered into Cassettes.

● Swab: Swabs for sample collection.

● Tube Stand: Stand to support tubes in a stable upright position.

● Package insert

Test Procedure

Bring devices, reagents and specimens and/or controls to room temperature (15~30℃) before use.

1. For each specimen swab, open the foil pouch just before testing and remove the test device, and put it on a clean, level surface. Label the tube with the patient identification. For best results, the assay should be performed within one hour.

2. Gently mix sample diluent buffer. Add 10 drops into the extraction tube.

3. For Nasal/ Nasopharyngeal Swabs

a. Insert the swab into the extraction tube. Mix well and squeeze the swab several times by compressing the walls of the tube against the swab.

b. Roll the swab head against the inside of the tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.

For Nasal Wash/Aspirate Specimens

a. Vortex or thoroughly mix specimen. Do not centrifuge, as the removal of cellular material may adversely affect test sensitivity.

b. Transfer 300 uL of specimen into the extraction tube using transfer pipette.

4. Insert filtered nozzle into sample extraction tube. Invert the tube and add 2 drops (approximately 100uL) of test sample into the sample well by gently squeezing the tube.

5. Read results at 15 minutes and disregard after 30 minutes.

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