D20rha25 2013-1
D20rha25 2013-1
D20rha25 2013-1
Introduction
Dengue viruses, caused of Dengue fever, transmitted by the mosquito, Aedes Caution: Dont read test results after 20 minutes. Reading too late can give false
aegypti and Aedes albopictus, are widely distributed throughout the tropical and results.
subtropical areas of the world. There are four known distinct serotypes (dengue virus
1, 2, 3 and 4). It usually follows symptoms of headache, fever, prostration, severe Interpretation of the results
joint and muscle pain, swollen glands and rash. Victims of dengue often have Negative:
contortions with to the intense joint and muscle pain. Dengue NS1 (non-structural The presence of only one band within the result window indicates a negative result.
protein1) is a highly conserved glycoprotein that is essential for the viability of If only the C band is present, the absence of any Black color in the test band (T)
Dengue virus and is produced both in membrane-associated and secretory forms by indicates that no anti-dengue virus antibodies are detected.
the virus. NS1 antigen is present at high concentration in the blood of dengue virus- Positive:
infected patients during the early clinical phase of the disease. BIOCREDIT Dengue The Red/purple and black bands appear: One in the control line (C) and test line
NS1 Ag test detect to Dengue virus NS1 antigen in human blood. The test is user (T).The presence of two color bands (T and C line) within the result window, no
friendly, without cumbersome laboratory equipment, and requires minimal staff matter which band appears first, indicates a positive result.
trainings. Invalid:
[Principle of test] BIOCREDIT Dengue NS1 Ag Test is a lateral flow chromatographic If the control band fails to appear within the result window, the result is considered
immunoassay. The test cassette is consist of: 1) a burgundy colored conjugate pad invalid. The directions may not have been followed correctly or the test may have
containing dengue antigens conjugated with colloid gold and BSA-gold conjugates, 2) deteriorated. It is recommended that the specimen be retested
a nitrocellulose membrane strip containing test band(T band) and a control band (C Note: There is no meaning attributed to line color intensity or width.
band). T band is pre-coated with mouse polyclonal antibody specific to NS1 anti-
dengue virus respectively and C band is pre-coated with Rabbit anti-BSA polyclonal
antibody.
Limitations and Interferences
1. The Assay Procedure and Test Results Interpretation must be followed closely
They, antibody BSA Dengue NS1 monoclonal antibody gold conjugates complex,
when testing the presence of antibodies to dengue virus in serum or plasma from
move along the membrane chromatographically and form a visible black band on the
test lines and purple/red band on the control line. This dual color system is easy to individual subjects. Failure to follow the procedure may give inaccurate results.
2. If the symptom persists, while the result from BIOCREDIT Dengue NS1 Ag Rapid
read results of the test.
Test is negative or non-reactive result, it is recommended to re-sample the patient
[Intended Use] BIOCREDIT Dengue NS1 Ag test is a lateral flow immunoassay for the
few days late or test with an altermative test device.
simultaneous detection of NS1 anti-dengue virus in human serum, plasma or whole
blood. It is intend to be used by the professionals as a screening test and as an aid in 3. The test procedure, precautions and interpretation of results for this test must be
the diagnosis of infection with dengue viruses. And reactive specimen with the followed precisely when testing.
BIOCREDIT Dengue NS1 Ag test must be confirmed with alternative methods. 4. This test kit detects antigen to Dengue NS1 Ag in serum, plasma and whole blood
of patient and is useful as a screening procedure of dengue NS1 Ag diagnosis.
5. BIOCREDIT Dengue NS1 Ag Rapid Test is limited to the qualitative detection of
Kit components antibodies to dengue virus in human serum, plasma and whole blood. The intensity
BIOCREDIT Dengue NS1 Ag Test Kit contains the following: of the test band does not have linear correlation with the antibody titer in the
- Each test device sealed in a foil punch with a desiccant specimen.
- Disposable dropper 6 BIOCREDIT Dengue NS1 Ag Rapid Test cannot be used to differentiate if the
- Assay diluent infection is primary or secondary.
-Instructions for use 7. Serological cross reactivity with other flaviviruses is common; therefore, it is
possible that patients infected with these bacteria may show some level of the
Precautions / Storage and Kit stability reactivity with this test.
For the reproducible results, users should be aware of the following and followed: 8. A negative or non-reactive result for an individual subject indicates absence of
1. BIOCREDIT Dengue NS1 Ag should be stored at room temperature (1~40C). Do detectable dengue virus antibodies. However, a negative or non-reactive test result
not store at refrigerator. does not preclude the possibility of exposure to or infection with dengue virus.
2. The test device is sensitive with humidity as well as heat. 9. A negative or non-reactive result can occur if the quantity of the dengue virus
3. Perform the test immediately after removing the test device from the foil pouch. antigen present in the specimen is below the detection limits of the assay, or the
4. Do not use the test kit if the pouch is damaged or the seal is broken. antigen that are detected are not present during the stage of disease in which a
5. Do not mix reagent of different lots. sample is collected.
6. Do not use it beyond the expiration date. 10. Some specimens containing unusually high titer of heterophile antibodies or
7. The shelf-life of the kit is as indicated on the outer package.. rheumatoid factor may affect expected results.
8. When transporting or storing the packages, avoid exposure to high temperature 11. The results obtained with this test should only be interpreted in conjunction with
(over 45C) for a period longer than 1 week. other diagnostic procedures and clinical findings.
R0702-019-H014 (Rev.1)
Issued date: 2013. 4. 9
R0702-019-H014 (Rev.1)
Issued date: 2013. 4. 9