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Dengue NS1 Test (Colloidal Gold)

Overview

The Test is intended for the in vitro qualitative detection of Dengue NS1 Antigen in human whole blood/serum/plasma. It provides an aid in the diagnosis of infection with Dengue viruses.

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

  • 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 pipette

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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. 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 (30μL).

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  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. Positive: The presence of two purple-red lines ("C" and "T") within the result window indicates positive for NS1.

  2. Negative: If the control line (C) is the only visible line within the result window, it indicates a negative result.

  3. Invalid: If the control line (C) fails to appear, even if the test line (T) 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

  • A negative result can occur if the concentration of Dengue virus NS1 Antigen present in the specimen is below the detection limits of the assay, or the antigens are not present during the stage of disease in which the specimen was collected.

  • A negative test result cannot exclude a recent infection.

  • The presence of detectable Dengue virus NS1 Antigen may mean positive for early Dengue infection. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

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

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