CE Mosquito Borne Disease Serum Dengue Rapid Test Cassette

Dengue NS1 Antigen Rapid Test

For the qualitative detection of Dengue NS1 Antigen in serum/plasma and whole blood

Dengue NS1 Antigen Rapid Test Kit Dengue Fever Home Use Mosquito-Borne Infectious Disease

Intended Use

The Dengue NS1 Antigen Rapid Test is a qualitative test for the detection of NS1 antigen of dengue virus in human serum or plasma.. Dengue fever is a worldwide health problem, and in epidemic proportions in some countries.

The World Health Organization estimates that annually, 50-100 million people are infected worldwide with the dengue virus.

Studies have shown that early detection of Dengue NS1 virus using tests like the Dengue NS1 Rapid test can help in early confirmation, clinical treatment, and control of dengue viral infections.This test is effective new diagnostic tools for early diagnosis of dengue virus infection. The test is for In-Vitro Diagnostic use only.

Principle

Serum, or plasma, samples may be used with this test. A sample is dispensed on to the membrane The sample then migrates by capillary action towards the test site where anti-Dengue antibodies are immobilized.

The NS1 antigen present in the sample will bind to the immobilized Mab-anti-Dengue Antibodies immobilized in the test zone. on the membrane.Next the sample buffer is applied which in turn reconstitutes the dried Dengue gold anti-NS1 mouse antibody conjugate.

The Dengue conjugate then migrates towards the test zone and binds to Dengue NS1 antigen-Dengue Anti-NS1 antibodiy to form a complex on the membrane as a separate red to blue lines if Dengue NS1 Antigens are present in the sample.

The intensity of the test lines will vary depending upon the amount of antigen present in the sample. The appearance of pink to dark blue line in the test region should be considered as positive for NS1 antigen in the sample.

There will be a second control line on the membrane which will be invisible until the test is run. It will show up as a red to blue control line to indicate that the test is functioning properly.

Specimen Collection and Preparation

Whole blood specimen collection

☀ Whole blood is collected in syringe or evacuated tube containing the anticoagulant.

☀ Whole blood specimens should be tested immediately after collection. In the case of storing at 2-8°C, it should be tested within 24 hours.

Plasma/Serum specimen collection

☀ Plasma or serum specimens should be tested immediately after collection.

☀ Do not leave the specimens at room temperature for prolonged period. Specimens may be stored at 2-8°C for up to 3days. For long term storage, specimens should be kept below -20°C.

Specimens containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to assay.

Assay Procedure

All test cassettes, and specimens must be at room temperature (4- 300C) before running the assay procedure. Serum or plasma samples should be used immediately after collection. The use of Icteric or Lipemic samples should be avoided.

☀ Pipette 30 μl of serum or plasma,or 50 μl of whole blood into the “S” well.

☀ Next dispense 2 drops of sample diluent buffer into the “S” well.

☀ Read the results between 15-20 minutes. Discard the test cassette after 20 minutes. Do not read after 20 min.

Interpretation of Results

Negative:

The control line is the only line visible in the test zone. No NS1 antigens were detected. The result does not exclude dengue infection.

Positive:

The control line and the test line line is visible in the test zone. The test is positive for NS1 antigens. This is indicative of dengue infection.

Invalid:

The test results are INVALID, if no control line is visible, regardless of the presence or absence of line in the test zone of the cassette.. Repeat the test using a new cassette.

Storage

Store the kit between 4°C and 30°C. Do not store the kit in direct sunlight. Only remove and open the number of cassettes to be immediately used. The test kit should be used until the expiration date of the kit. Please refer to the package label for the expiration date.

Limitation

☀ This test detects the presence of NS1 dengue antigen in the sample and should not be used as the sole criterion for the diagnosis of a dengue viral infection.

☀ As with all diagnostic tests, the results must be correlated with clinical findings. If the results is negative and a dengue infection suspicion still exists, additional follow up testing using other clinical methods is recommended.

☀ A negative serological result at any time does not preclude the possibility of an early infection of dengue virus.

☀ This is only a screening test. Most alternative diagnostic test should be used as additional follow up test such as isolation of virus, antigen detection in fixed tissue, RT-PCR, and Haemagglutination inhibition of dengue virus infection .