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.
- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- 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.
- Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
Zika Virus IgG/IgM part
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IgG Positive:* The colored line in the control line region (C) appears, and a colored line appears in test line region G. The result is positive for Zika Virus virus specific-IgG and is probably indicative of secondary Zika Virus infection. |
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IgM Positive:* The colored line in the control line region (C) appears, and a colored line appears in test line region M. The result is positive for Zika Virus virus specific-IgM antibodies and is indicative of primary Zika Virus infection. |
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IgG and IgM Positive:* The colored line in the control line region (C) appears, and two colored lines should appear in test line region G and M. The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary Zika Virus infection. |
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Negative: The colored line in the control line region (C) appears. No line appears in test line regions 1 or 2 (T1 or T2). |
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INVALID: Control line (C) fails to appear. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor. |
Zika Virus NS1 Part
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.
