Dengue IgM and/or IgGRapid Test Cassette (whole blood)
Dengue IgM and/or IgGRapid Test Cassette is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM and IgG anti-dengue in human whole blood. The kit is a diagnostic device for qualitative detection .
When a specimen is added to the test, IgG and IgM antibodies in the specimen sample react with gold particles labeled with dengue envelope proteins. As this specimen/particle mixture migrates along the length of the test, the anti-dengue IgG and/or IgM antibody particle complex is captured by the relevant IgG and IgM test bands located in the test device window causing a pale to dark red band to form at the test region of the cassette window. The intensity of the bands will vary depending upon the amount of antibody present in the sample. The appearance of any color in test region should be considered as positive for IgG and/or IgM antibody. A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.
For whole blood specimen, collect fresh blood specimen just prior to using the assay. Specimens must be fresh. Whole bloodcollected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze wholeblood specimens. Whole blood collected by fingerstick should be tested immediately.
1. Open a pouch containing a cassette, remove the testkit from the pouch and place it
horizontally on the desk.
2. Pipette 1 drop (5µl) of specimen into the same well and then drop 1 drop(about 50µl) of diluent into the same well.
3.Then draw one drop of the buffer into the sample well as well.
4. Read results within 10 minutes. Do not read results after 20 minutes.
INTERPRETATION OF RESULTS
Negative: Only control pink band appears on test region of the cassette. This indicates that there is no anti-dengue IgMand IgG in the specimen.
Positive: Three pink bands(C,G,M) ,two pink bands(C,G) or(C,M) appear on test region of the cassette. This indicates that the specimen contains detectable amount of anti-dengue IgGand IgM, only IgG, only IgM.
Invalid: If without colored band appears atcontrol region, this is an indication of a possible error in performing the test. The test should be repeated using a new one.
1,Must use fresh specimen and avoid repetitive freezing, the result will be invalid
2,Use it before expiry date.
3,The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator. Use the test kit as soon as possible but within 1 hour after removal from pouch specially if the room temperature is more than 30°C and in high humidity environment.
4,Old serum can not be used. If the serum is thick, it can be used only after being separated.
1,The test is for in-vitro diagnostic use only.
2,The test is qualitative filter detection,it can not be used as the final test for blood donor.
STORAGE AND STABILITY
The test kit can be stored at room temperature (18 to 30°C) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.