Zika lgG/IgM and NS1 Combo Test

INTENDED USE

The Zika Virus IgG/IgM And NS1 Combo Test is a rapid chromatographic immunoassay for the qualitative detection of Zika Virus NS1 antigen and IgG/IgM antibodies to Zika Virus in human whole blood, serum or plasma specimen.

MATERIALS

Materials Provided

• Test Devices
• Disposable specimen dropper
• Package insert

Materials Required But Not Provided

• Specimen collection container
• Lancet
• Centrifuge (for plasma only)
• Timer

• TEST PROCEDURE

  Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°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.

  Zika Virus IgG/IgM part

  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 mL) 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.

   

  Zika Virus NS1 part

  To use a dropper: Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 2 drops (about 60µL) of plasma/ serum specimen or 3 drops(about 90µL)  of whole blood specimen into the sample well making sure that there are no air bubbles.

  Note: Add 1 drop of Saline or Phosphate-Saline buffer (common buffers used in clinic not provided in the kit) into the sample well if flow migration is not observed within 30 seconds in the result window, which could occur with a highly viscous specimen.

  3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

  INTERPRETATION OF RESULTS

  POSITIVE: Both colored C and T bands appear in the test and control region.

  NEGATIVE: Only one colored line appears in the control region.

  INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.