Dengue IgG/IgM&NS1 Test (Colloidal Gold)

Summary

• Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitos. It is widely distributed throughout the tropical and subtropical areas of the world and causes up to 100 million infections annually. Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia, and rash. The test detects Dengue virus antigen in human whole blood/serum/plasma. It is a non-invasive method and does not use radioactive isotopes.

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Contents Include

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

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

• 20 micropipette: Micropipette with 10μL marker line

• 20 pipette: Pipette without 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. For IgG/IgM Test: Use the micropipette with 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.

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  5. For NS1 Test:
      Serum/plasma: Use the pipette to apply 2 drops of serum/plasma (80μL) into the specimen well.

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  Whole blood: Use the pipette to apply 2 drops of whole blood (80μL) into the specimen well, and then apply 1 drop of   diluent.

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

 

Results Interpretation

1. Negative: If only the control line(C) is developed, the result is negative.

2. Positive:

For IgG/IgM Test: Control line(C)and at least one test line are visible within the result window . The appearance of IgG test line (G) indicates the presence of dengue specific IgG antibodies. The appearance of IgM test line (M) indicates the presence of dengue specific IgM antibodies. And if both IgG test line (T) and IgM test line (T) appear, it indicates that the presence of both dengue specific IgG and IgM antibodies.

 

 

 

 

 

 

 

For NS1 Test: The presence of both the control line (C) and NS1 line within the result window indicates positive for Dengue NS1.

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​​  3. Invalid: If the control line (C) fails to appear, even if the NS1 or G/M line is visible, the result is invalid. 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

1. The kit is for in vitro diagnostic use only. DO NOT RE-USE

2. This test detects the presence of IgG/IgM antibodies and NS1 antigen to dengue in the specimen and should not be used as the sole criterion of Dengue virus infection.

3. 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.

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

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

6. 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 with the dengue virus.

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