Detailed Description
"Allow the test device, buffer, and/or controls to equilibrate to room temperature(15-30℃) prior to testing.
1.Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2.Place the cassette on a clean and level surface. Be sure to label the device with specimen's ID number.
3.With a 5 μL mini plastic dropper provided, draw whole blood specimen to exceed the specimen line as showed in the following image and then transfer drawn whole blood into the sample well(S).Then add 3 drops (about 120 μL) of buffer to the buffer well(B) immediately.
Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by pipette capable to deliver 5 μL of volume.
4.Set up timer. If preferred, after 5 minutes of adding specimen and buffer, you may add one more drop of buffer to help the background become clearer.
5.Results can be read in 20 to 30 minutes. It may take more than 20 minutes to have the background become clearer. Don't read results after 30 minutes. To avoid confusion, discard the test device after interpreting the result."
Directions For Use
Clinical performance for P.f Ag test
sensitivity: more than 99.9%
specificity: 98.7%
Total accuracy: 98.9%
Clinical performance for P.v Ag test
sensitivity: more than 99.9%
specificity: 98.7%
Total accuracy: 99%