Chikungunya IgG/IgM Rapid Test

INTENDED USE

The Chikungunya IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG/IgM anti-chikungunya virus (CHIK) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with CHIK. Any reactive specimen with the Chikungunya IgG/IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

MATERIALS

Materials Provided

 Individually packed test devices

 Assay buffer

 Disposable specimen dropper

 Package insert

Materials Required but Not provided

 Specimen collection container

 Lancet

 Centrifuge

 Timer

TEST PROCEDURE

Allow the test, reagents, swab specimen, and/or controls to reach 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.

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 Assay buffer (approximately 90 L)

and start the timer. 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 Assay buffer (approximately 90 µL) and start the timer.
• To use a micropipette: Pipette 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.

3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

IgG POSITIVE:* Purplish red line appears in control line region (C), and purplish red line appears in test line region (G). The result is positive for Chikungunya specific-IgG and is probably indicative of                        secondary Chikungunya infection.

IgM POSITIVE:* Purplish red line appears in control line region (C), and purplish red line appears in test line region (M). The result is positive for Chikungunya specific-IgM antibodies and is indicative of primary Chikungunya infection.

IgG AND IgM POSITIVE:* Purplish red line appears in the control line region (C), and two Purplish red lines should appear in the test line region G and M, and the color intensity of the lines need not match. Resulting the IgG and IgM antibodies were positive, indicating the presence of anti-Chik IgG and IgM in the specimens.

*NOTE: Therefore, any shade of color in the test line region(s) (G and/or M) should be considered positive.

NEGATIVE: Purplish red line appears in the control line region (C). No lines appear in the test line region G and M.

NVALID: No line appears on control line (C). Insufficient sampling amount or improper sampling method may indeed lead to the fault of control line.

Check the addition pattern and repeat the procedure with a new test device. If the problem persists, stop using the test suite immediately and contact your local distributor.

LIMITATION

1. 1. The TEST PROCEDURE and the INTERPRETATION OF RESULTS must be followed closely when testing the presence of IgM anti-CHIK in serum, plasma or whole blood from individual subjects. Failure to follow the

procedure may give inaccurate results.

2. 2. The Chikungunya IgG/IgM Rapid Test is limited to the qualitative detection of IgM anti-CHIK in human serum, plasma or whole blood. The intensity of the test region does not have the linear correlation with the

antibody titer in the specimen.

3. 3. A negative result for an individual subject indicates absence of detectable IgM anti-CHIK. However, a negative test result does not preclude the possibility of exposure to or infection with CHIK.

4. 4. A negative result can occur if the quantity of IgM anti-CHIK present in the specimen is below the detection limits of the test, or the antibodies that are detected are not present during the stage of disease in which a

sample is collected.

5. 5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

6. 6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.
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