Detailed Description
Allow the test device, specimen, buffer and/or controls to reach 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.
For Serum, Plasma or Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.
For Fingerstick Whole Blood specimens: Fill the capillary tube and transfer approximately 50 µL of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.
3.For hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 µL) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.
4.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not read results after 20 minutes.
Directions For Use
Clinical sensitivity: more than 99.9%
Clinical specificity: 99.6%
Total accuracy: 99.7%