Dengue NS1 Rapid Test

Short Description:

The Dengue NS1 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.

Used For: Dengue NS1 Antigen Rapid Test

Specimen:whole blood, serum or plasma

Certification:CE

MOQ:1000

Delivery time:2-5 days after Get payment

Packing:20 tests kits/Packing box

Shelf Life:24 Months

Payment:T/T, Western Union, Paypal

Assay Time: 10-15 Minutes


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INTRODUCTION

Dengue viruses, transmitted by the mosquito, Aedes aegypti and Aedes albopictus mosquitoes, are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes (dengue virus 1, 2, 3 and 4). In children, infection is often subclinical or causes a self-limited febrile disease. However, if the patient is infected second times with a different serotype, a more severe disease, dengue hemorrhagic fever or dengue shock syndrome, is more likely to occur. Dengue is considered to be the most important arthropod-borne viral disease due to the human morbidity and mortality it causes. NS1 is a highly-conserved glycoprotein that is present at high concentrations in the sera of dengue-infected patients during the early clinical phase of the disease. NS1 antigen is found from the first day and up to 9 days after onset of fever in sample of primary or secondary dengue infected patients.

The Dengue NS1 Antigen Rapid Test is a rapid test that utilizes a combination of anti-dengue NS1 Ag coated colored particles for the detection of Dengue NS1 antigen in human whole blood, serum, or plasma.

MATERIALS

Materials Provided

·         Individually packed test devices

·         Disposable pipettes

·         Package insert

Materials Required but Not provided

·         Specimen collection container

·         Centrifuge

·         Micropipette

·         Timer

·         Lancets

PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (1530°C) before use.

  1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
  2. Using the provided disposable pipette, transfer 3 drops of specimen (approximately 75 µL) to the specimen well (S) of the device, then start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

  1. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

  1. A negative result can occur if the quantity of Dengue virus NS1 antigen present in the specimen is below the detection limits of the assay, or the antigens that are detected are not present during the stage of disease in which a sample is collected.
  2. A negative test result cannot exclude a recent infection.
  3. The presence of detectable Dengue virus NS1 Ag 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.

Relative Sensitivity: 92.98% (95%CI: 86.57%96.59% 

Relative Specificity: 98.24% (95%CI95.40%99.47%

Accuracy: 96.48% (95%CI93.89%98.04%


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