IVD Infections disease diagnostic flu A&B home rapid test kit CE Marked

One Step Influenza A&B Test is a rapid qualitative assay that detects influenza type A (including

the subtype H1N1) and B nucleoprotein antigens extracted from the nasal swab specimen.

These devices are used to aid in the differential diagnosis of influenza type A and B infection.

Influenza is a highly contagious, acute, viral infection of the respiratory tract. The causative

agents of the disease are immunologically diverse, single-strand RNA viruses known as

influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are

the most prevalent and are associated with most serious epidemics. Type B viruses produce a

disease that is generally milder than that caused by type A. Type C viruses have never been

associated with a large epidemic of human disease. Both type A and B viruses can circulate

simultaneously, but usually one type is dominant during a given season.

Influenza antigens may be detected in clinical specimens by immunoassay. The One Step

Influenza A&B test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies

that are specific for influenza antigens. The test is specific to influenza types A and B antigens

with no known cross-reactivity to normal flora or other known respiratory pathogens.

Procedure and Result Reading of Flu A&B Rapid Test Device

1. All reagents should be warmed to room temperature before use.
 

2. Open aluminum foil bags, take out the test kit, put on a horizontal plane, suck three

to four drops of nasal swab sample with the dropper, then add it to the Sample Port.
 

3. Record the result at 10 to 15 minutes, after 15 minutes record the result to be invalid

or not.