Medical Implements

INTENDED USE
This kit is an in vitro immunoassay membrane test (Dot-ELISA) for the direct rapid and qualitative detection of Influenza A viral antigen in avian excretes, human nasopharyngeal aspirates, swabs, nasal wash, chicken embryo whole virus inoculation or viral lysates, etc. It is intended for clinical identification of type-A influenza viruses.The use of this immuno-filtration assay provides rapid reliable and safe diagnostic method for detection of Influenza A Antigen within 30 minutes. Simple use device that has integrated quality control dot and do not require any additional laboratory equipment.

SPECIMEN COLLECTION,TRANSPORTATION AND STORAGE
1.For liquid specimens (e.g. viral lysates, virus innoculations) - mix 200ul of each specimen with 400ul of virus lysis buffer.
2.In case that solid specimens will be tested (e.g. fecal,cloacae samples), such sample must be firstly dissolved 1:10 with a normal saline solution (for example 0.1g of sample mixed with 1ml of lysis buffer).
3.For specimens collected into cotton swabs, firstly elute the samples with 1ml of a normal saline solution.

INTERPRETATION OF RESULTS AND QUALITY CONTROL
Read the results in a well-lighted area within 3-5 minutes. Record the test results.
1.Positive Test (antigen present)- In addition to the blue dot in the Control Zone, a distinctive green ellipse will appear at the Test Zone, indicating that NP of influenza A virus has been detected using this Dot-ELISA Test.
2.Negative Test (no antigen detected) - Only the blue dot appears in the Control Zone, indicating that no NP of influenza A virus has been detected with this Dot-ELISA Test. However, this does not exclude the possibility of infection with influenza A virus.
3.Quality Control: A blue dot always appears in the Control Zone. If no blue dot appears in the Control Zone, the test is invalid; discard the test and repeat with a new sample and new device.