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Dengue IgG/IgM Test (Colloidal Gold)

Overview

The kit is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to dengue virus in human whole blood/serum/plasma. It provides an aid in the diagnosis of infection with Dengue viruses.

Contents Include

  • 25 test cassettes: each sealed foil pouch containing one test device and one desiccant

  • 6mL*1 vial Specimen diluent: 50mM PBS, Sodium Casein, ProClin 300

  • 25 micropipette: Micropipette with 10μL marker line

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Storage and Stability​

  • Stored at 4°C~ 30°C(39.2°F~ 86°F)in a dry place and avoid direct sunlight. The validity period is 18 months (see the label for the specific batch number and expiration date). Do not freeze.

  • After the specimen diluent is opened, it should be recapped immediately after use and stored at 4°C~30°C (39.2°F~86°F), and the validity period is 6 months.

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Specimen Collection and Handling

  • Consider any materials of human origin as infectious and handle them using standard bio-safety procedures.

  • The test can be used on whole blood/serum/plasma.

  • Collect whole blood, serum, or plasma specimens following regular clinical laboratory procedures.

  • Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Whole blood should be stored at 2°C~8°C if the test is to be run within 3 days of collection. Do not freeze whole blood specimens. Serum and plasma specimens may be stored at 2°C~8°C for up to 2 weeks or kept below -15°C for long-term storage.

  • Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed for more than 6 cycles.

  • Do not use specimens demonstrating gross lipemia, gross hemolysis, or turbidity to avoid interference with result interpretation.

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Test Procedure

  1. Allow the test, specimen, diluent, and/or controls to reach room temperature 15°C~30°C (59°F~86°F) prior to testing.

  2. Bring the pouch to room temperature before unsealing it. Remove the test device from the sealed pouch and use it as soon as possible.

  3. Place the test device on a clean and level surface.

  4. Use the micropipette with a 10μL marker line to collect and apply 20μL whole blood or 10μL serum/plasma into

    the specimen well, and then apply 2 drops of diluent (approximately 80μL).

  5. Wait for the colored line(s) to appear. Read results within 15~20 minutes. Do not read the results after 20 minutes.

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Results Interpretation

  1. Negative: The control line (C) is the only visible line within the result window. No IgG or IgM antibodies were detected. Retest in 3-5 days if dengue infection is suspected.

  2. IgM Positive: The control line (C) and the IgM line (M) are visible within the result window. This is positive for IgM antibodies to the Dengue virus. This is an indication of primary dengue infection.

  3. IgG Positive: The control line (C) and IgG line (G) are visible within the result window. This is positive for IgG antibodies to Dengue virus. This is indicative of secondary or previous dengue infection.

  4. IgG and IgM Positive: The control line (C), IgG (G) and IgM (M) lines are all visible within the result window. This is positive for both IgG and IgM antibodies. This is indicative of late primary or early secondary dengue infection.

  5. Invalid: The control line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the likeliest reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local distributor.

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Limitations

  • The kit is for in vitro diagnostic use only.

  • This test detects the presence of antibodies to dengue in the specimen and should not be used as the sole criterion of Dengue virus infection.

  • In early infections and some secondary infections, detectable levels of IgM antibodies may be low. Some patients may not produce detectable levels of antibodies within the first 7-10 days after infection. If clinical symptoms persist, patients should be retested in 3-4 days.

  • There may be serological cross-reactions between flavivirus groups.

  • As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

  • If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not preclude the possibility of early infection of the dengue virus.

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