"Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Remove the test device 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 test device on a clean and level surface.
3.For Serum, Plasma or Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of specimen (approximately 80 μL) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 μL) and start the timer.
4.Wait for the red line(s) to appear. The result should be read at 10 minutes. Do not interpret results after 20 minutes. "
Directions For Use
"Clinical sensitivity: more than 99.9%
Clinical specificity: 99.6%
Total accuracy: 99.8%"