1) Twenty five (25) BIONOTE DENGUE NS1 Ag Rapid test kits
2) Twenty five (25) Disposable droppers
3) One (1) instruction for use
The BIONOTE DENGUE NS1 Ag Rapid Test Kit is a chromatographic immunoassay for the qualitative detection of Dengue virus NS1 antigens in whole blood, serum or plasma
■ Specimen Collection and Preparation
1) The test should be performed using serum, plasma, or whole blood.
2) [Whole blood]
① Collect the whole blood into the collection tube containing EDTA, citrate or heparin by venipuncture.
② If specimens are not immediately tested, they should be refrigerated at 2 ~ 8°C. For storage periods greater than three days, freezing is recommended. They should be brought to room temperature prior to use. Using the specimen in the long-term keeping more than three days can cause non-specific reaction.
③ When storage at 2 ~ 8°C, the whole blood sample should be used with 3 days.
Collect an anticoagulated blood sample using standard clinical laboratory procedures. Separate plasma by centrifugation. Plasma samples may be stored refrigerated (2~8℃) for up to 72hours, for longer storage freeze at or below -20℃ in vials with air-tight seals.
Collect and prepare serum samples using standard clinical laboratory procedures. Serum samples may be stored refrigerated (2~8℃) for up to 72 hours, for longer storage freeze at or below -20℃ in vials with air-tight seals.
■ Procedure of the test
1) Allow all kit components and specimen to room temperature prior to testing.
2) Remove the test device from foil pouch, and place it on a flat, dry surface.
3) Add 2 drops (about 80㎕) of whole blood, serum or plasma into the sample well, using a disposable dropper.
4) Interpret test results at 15~20 minutes. Do not interpret after 30 minutes.
■ Interpretation of the test
A colored band will appear in the left section of the result window to show that the test is working properly. This band is the control band. The right section of the result window indicates the test result. If another colored band appears in the right section of the result window, it is the test band.
1) Negative result
The presence of one color band ("C" Control line) within the result window indicates a negative result.
2) Positive result
The presence of two color bands ("T" Test line and "C" Control line) within the result window, no
matter which band appears first, indicates positive result.
3) Invalid Result
If the control band ("C" Control line) fails to appear within the result window, the result is
considered invalid. The directions may not have been followed correctly or the test may have
deteriorated. It is recommended that the specimen should be re-tested.
1) The test procedure, precautions and interpretation of results for this test must be followed when testing.
2) Although the test is very accurate in detecting antigen specific to Dengue virus, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
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 a second time 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. Usually IgM does not become detectable until 5 to 10 days after the onset of illness in cases of primary dengue infection and until 4 to 5 days after onset of illness in secondary infections.