RapiGEN BIOCREDIT Dengue NS1 Ag Test
One Step Dengue NS1 Ag Rapid Test
Introduction
Dengue viruses, caused of Dengue fever, transmitted by the mosquito, Aedes
aegypti and Aedes albopictus, 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). It usually follows symptoms of headache, fever, prostration, severe
joint and muscle pain, swollen glands and rash. Victims of dengue often have
contortions with to the intense joint and muscle pain. Dengue NS1 (non-structural
protein1) is a highly conserved glycoprotein that is essential for the viability of
Dengue virus and is produced both in membrane-associated and secretory forms by
the virus. NS1 antigen is present at high concentration in the blood of dengue virus-
infected patients during the early clinical phase of the disease. BIOCREDIT Dengue
NS1 Ag test detect to Dengue virus NS1 antigen in human blood. The test is user
friendly, without cumbersome laboratory equipment, and requires minimal staff
trainings.
[Principle of test] BIOCREDIT Dengue NS1 Ag Test is a lateral flow chromatographic
immunoassay. The test cassette is consist of: 1) a burgundy colored conjugate pad
containing dengue antigens conjugated with colloid gold and BSA-gold conjugates, 2)
a nitrocellulose membrane strip containing test band(T band) and a control band (C
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.
They, antibody BSA Dengue NS1 monoclonal antibody gold conjugates complex,
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
read results of the test.
[Intended Use] BIOCREDIT Dengue NS1 Ag test is a lateral flow immunoassay for the
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
the diagnosis of infection with dengue viruses. And reactive specimen with the
BIOCREDIT Dengue NS1 Ag test must be confirmed with alternative methods.
Kit components
BIOCREDIT Dengue NS1 Ag Test Kit contains the following:
- Each test device sealed in a foil punch with a desiccant
- Disposable dropper
- Assay diluent
-Instructions for use
Precautions / Storage and Kit stability
For the reproducible results, users should be aware of the following and followed:
1. BIOCREDIT Dengue NS1 Ag should be stored at room temperature (1~40C). Do
not store at refrigerator.
2. The test device is sensitive with humidity as well as heat.
3. Perform the test immediately after removing the test device from the foil pouch.
4. Do not use the test kit if the pouch is damaged or the seal is broken.
5. Do not mix reagent of different lots.
6. Do not use it beyond the expiration date.
7. The shelf-life of the kit is as indicated on the outer package..
8. When transporting or storing the packages, avoid exposure to high temperature
(over 45C) for a period longer than 1 week.
Specimen collection and storage and precaution
[Collection by venipuncture]
1.Collect the whole blood into the collection tube (containing EDTA, citrate or heparin)
by venipuncture.
2. Using the specimen in the long-term keeping more than 3 days can cause non-
specific reaction.
3. When storage at 2 ~ 8C, the whole blood sample should be used within 3 days.
[Collection using a lancet]
1. Clean area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce with a sterile lancet provided.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Take a sample pipette provided, and while squeezing the tube, immerse the open
end in the blood drop and then gently release the pressure to draw blood into the
sample pipette up to the black line.
[Precaution]
1. Anticoagulants such as heparin, EDTA, and citrate do not affect the test result.
2. As known relevant interference, haemolytic samples, rheumatoid factors contained
samples and lipaemic; icteric samples can lead to impair the test results.
3. Use separate disposable capillary pipettes or pipette tips for each sample in order
to avoid cross contamination of either samples which could cause erroneous
results.
Procedure of the test (Refer to figure)
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. Clean the fingertip and prick the finger with lancet.
4. With a disposal dropper(30) provided, draw whole blood specimen to black line
and then transfer drawn whole blood into the sample well.
5. Add 2 drops of assay diluents into the buffer well.
5. Wait of 20 minutes and read result.
Cat.No.D20RHA25
Caution: Dont read test results after 20 minutes. Reading too late can give false
results.
Interpretation of the results
Negative:
The presence of only one band within the result window indicates a negative result.
If only the C band is present, the absence of any Black color in the test band (T)
indicates that no anti-dengue virus antibodies are detected.
Positive:
The Red/purple and black bands appear: One in the control line (C) and test line
(T).The presence of two color bands (T and C line) within the result window, no
matter which band appears first, indicates a positive result.
Invalid:
If the control band 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 be retested
Note: There is no meaning attributed to line color intensity or width.
Limitations and Interferences
1. The Assay Procedure and Test Results Interpretation must be followed closely
when testing the presence of antibodies to dengue virus in serum or plasma from
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
Test is negative or non-reactive result, it is recommended to re-sample the patient
few days late or test with an altermative test device.
3. The test procedure, precautions and interpretation of results for this test must be
followed precisely when testing.
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
antibodies to dengue virus in human serum, plasma and whole blood. The intensity
of the test band does not have linear correlation with the antibody titer in the
specimen.
6 BIOCREDIT Dengue NS1 Ag Rapid Test cannot be used to differentiate if the
infection is primary or secondary.
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
reactivity with this test.
8. A negative or non-reactive result for an individual subject indicates absence of
detectable dengue virus antibodies. However, a negative or non-reactive test result
does not preclude the possibility of exposure to or infection with dengue virus.
9. A negative or non-reactive result can occur if the quantity of the dengue virus
antigen present in the specimen is below the detection limits of the assay, or the
antigen that are detected are not present during the stage of disease in which a
sample is collected.
10. Some specimens containing unusually high titer of heterophile antibodies or
rheumatoid factor may affect expected results.
11. The results obtained with this test should only be interpreted in conjunction with
other diagnostic procedures and clinical findings.
Warning
1. For in vitro diagnostic use only. Do not use the used test device.
2. The instruction must be followed exactly to get accurate results. Anyone performing
an assay with this product must be trained in its use and must be experienced in
laboratory procedures.
3. Do not eat or smoke while handling specimens.
4. Wear protective gloves while handling specimens. Wash hands afterwards.
5. Avoid splashing or aerosol formation.
6. Clean up spills thoroughly using an appropriate disinfectant.
7. Decontaminate and dispose of all specimens, reaction kits and potentially
contaminated materials in a biohazard container as if they were infectious waste.
8. Do not mix and interchange different specimen.
9. Do not pipette by mouth.
References
1. V. Kumarasamy, A.H. Abdul Wahab, S.K. Chua, Z. Hassan, Y.K. Chem, M.
Mohamad, K.B. Chua. Evaluation of a commercial dengue NS1 antigen-capture ELISA
for laboratory. J Virol Methods. 2007 Mar;140(1-2):75-9.2.
2. Kassim FM, Izati MN, TgRogayah TA, Apandi YM, Saat Z.. Use of dengue NS1
antigen for early diagnosis of dengue virus infection. Southeast Asian J Trop Med
Public Health. 2011 May;42(3):562-9.
Product Disclaimer:
Whilst every precaution has been taken to ensure the diagnostic ability and accuracy of this
product, the product is used outside of the control of the Manufacturer and Distributor and the
result may accordingly be affected by environmental factors and / or user error. A person who
is the subject of the diagnosis should consult a doctor for further confirmation of the result.
Warning:
The Manufacturers and Distributors of this product shall not be liable for any losses, liability,
claims, costs or damages whether direct or indirect or consequential arising out of or related to
an incorrect diagnosis, whether positive or negative, in the use of this product.
R0702-019-H014 (Rev.1)
Issued date: 2013. 4. 9
R0702-019-H014 (Rev.1)
Issued date: 2013. 4. 9