A rapid test for the qualitative detection of antibodies (IgG and IgM) to Dengue virus in whole blood, serum, or plasma. For professional in vitro diagnostic use only. INTENDED USE The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections. DIRECTIONS FOR USE Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing. 1.Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible. 2.Place the test device on a clean and level surface. For Serum or Plasma Specimens: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 μL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 L) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S). For Whole Blood (Venipuncture/Fingerstick) Specimens: To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 uL) and start the timer. See illustration below. To use a micropipette: Pipet and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below. 3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.