Medical Implements

Flu A(H1N1) Rapid Test kit

INTENDED USE
WKEA Flu A (H1N1) rapid test kit (Colloidal Gold hnmunochromatographic Strip Assay) is to be used for detection of Flu A(H1N1) virus in nasal cavity secretion. The assay will recognize a variety of subtype of Flu A (H1N1) virus
It is intended to aid in the rapid diagnosis of Flu A (H1N1) viral infection
For in vitro diagnostic use only. For professional use only

SUMMARY AND EXPLANATION OF THE TEST
Influenza (commonly known as& quot;Flu& quot;)is a highly contagious acute viral infection of the respiratory tract. Only influenza A viruses are further classified by subtype on the basis ofthe two main surface glycoproteins hemagglutinin (HA) and neuraminidase (NA). Subtypes ofinfluenza A that are currently circulating among people worldwide include H1N1,H1 N2 and H3N2 viruses. WKEA Flu A (H1N1) Rapid Test Kit is a point
of-care test to aid in the diagnosis ofinfection A type influenza

PRECAUTIONS
1.This kit is for in vitro use only. Do not swallow
2.Do not mix components from different kit lots
3.Do not use test kit beyond the expiration date
4.Do not use the kit if the pouch is punctured or not well sealed
5.Keep out of the reach of children
6.Discard after useThe test device cannot he used more than once
7.The extraction tube and nasal swab are single use items - do
not use with multiple specimens
8.All specimens should be treated as potentially infectious
diseases. Protection glove should be worn when handling
the specimen. Wash hands Thoroughly afterwards
9. Avoid splashing or aerosol formation
10. DISPOSAL OF THE DIAGNOSTIC: The used device, swab and extraction tube have the infectious risk. The process of disposing the diagnostic must follow the local Infectious disposal law or laboratory rule

STORAGE
1.Store the kit at room temperature (4 Centigrade-30 Centigrade) in the sealed pouch up to the expiration date
2.Keep away from sunlight, moisture and heat