Dengue NS1 Ag Test Kit In-vitro Diagnostic Sample For Whole Blood, Serum, Plasma

【INTENDED USE】

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. Serum and Plasma sample is better recommended for testing.

【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 Ag 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.

【PRINCIPLE】

This kit is used for qualitative detection of dengue virus NS1 antigen in human serum, plasma or whole blood by immunochromatography and double-antibody sandwich method. Monoclonal antibody against DENGUE virus NS1 protein is coated on nitrocellulose membrane detection area (T), and anti-mouse IgG polyclonal antibody is coated on quality control area (C). When the sample contains dengue NS1 antigen and the concentration is higher than the minimum detection limit, Monoclonal antibodies against DENGUE virus NS1 protein labeled with colloidal gold bind to dengue virus NS1 antigen in serum, plasma, or whole blood to form a reaction complex, which moves forward along the nitrocellulose membrane by chromatography. It binds to monoclonal antibody of anti-dengue NS1 antigen precoated in the detection region (T) of nitrocellulose membrane to form a complex, and finally forms a visible red reaction line, at which time the result is positive. In contrast, when the sample does not contain dengue NS1 antigen or the concentration is below the minimum detection limit, there is no red response line in the test area (T), and the result is negative. Regardless of whether the sample contains NS1 antigen, a red reaction line will be formed in the quality control area (C).

【CONTENTS】

• Rapid Test.

• Buffer

• Disposable pipettes

• Instruction for use.

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

• The test must remain in the sealed pouch until use.

• Keep away from direct sunlight, moisture and heat.

• Do not freeze.

• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

【OPERATION】

Bring tests, specimens, buffer and/or controls to room temperature (15- 30°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 2 drops of Serum or Plasma specimen into the center of the specimen well(s) of the test cassette. OR Transfer 1 drop of Whole Blood specimen into the center of the specimen well(s) of the test cassette, then add 1 drop of buffer, and 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.

3. Wait for the colored band(s) to appear. The result should be read at 15 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 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

【WARNINGS AND PRECAUTIONS】

• Immunoassay for in vitro diagnostic use only.

• Do not use after expiration date.

• The test should remain in the sealed pouch until use.

• The used test should be discarded according to local regulations.

【TEST LIMITATIONS】

1.The Dengue NS1 Ag Rapid Test is for in vitro diagnostic useonly. Thetest should be used for the detection of Dengue NS1 antigeninwholeblood, serum or plasma specimens only.

2.The Dengue NS1 Ag Test will only indicate the presence of DengueNS1antigen in the specimen and should not be used as the sole criteriaforthediagnosis of Dengue.

【QUALITY CONTROL】

 Internal procedural controls are included in the test. Redbandappearing in the control region (C) is considered an internal positiveprocedural control, confirming sufficient specimen volumeandcorrectprocedural technique.

 External controls are not supplied with this kit. It is recommendedthatpositive and negative controls be tested as a good laboratorypracticetoconfirm the test procedure and to verify proper test performance.

For further operation or performance details, please refer to final instruction manual.