Dengue NS1 Ag-IgG/IgM Combo Test
Cat. No.: RF0143D
SAMPLE: Whole Blood / Serum / Plasma
FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY
The Dengue NS1 Ag-IgG/IgM Combo Test is a rapid chromatographic
immunoassay for the qualitative detection of antibodies (IgG and
IgM) and dengue virus NS1 antigen to dengue virus in Whole Blood
/Serum / Plasma to aid in the diagnosis of Dengue viral infection.
Dengue is transmitted by the bite of an Aedes mosquito infected
with any one of the four dengue viruses. It occurs in tropical and
sub-tropical areas of the world. Symptoms appear 3—14 days after
the infective bite. Dengue fever is a febrile illness that affects
infants, young children and adults. Dengue haemorrhagic fever
(fever, abdominal pain, vomiting, bleeding) is a potentially lethal
complication, affecting mainly children. Early clinical diagnosis
and careful clinical management by experienced physicians and
nurses increase survival of patients. Dengue NS1 Ag-IgG/IgM Combo
Test is a simple, visual qualitative test that detects dengue virus
antibodies and dengue virus NS1 antigen in human Whole
Blood/serum/plasma. The test is based on immunochromatography and
can give a result within 15 minutes.
The Dengue NS1 Ag-IgG/IgM Combo Test is a qualitative membrane
strip based immunoassay for the detection of dengue virus
antibodies (IgG and IgM) and dengue virus NS1 antigen in Whole
Blood /Serum / Plasma.
For IgG/IgM Test
The test device consists of: 1) a burgundy colored conjugate pad
containing dengue recombinant envelope antigens conjugated with
Colloid gold (dengue conjugates), 2) a nitrocellulose membrane
strip containing two test lines (T1 and T2 lines) and a control
line (C line). The T1 line is pre-coated with the antibody for the
detection of IgM anti-dengue, T2 line is coated with antibody for
the detection of IgG anti-dengue. When an adequate volume of test
specimen is dispensed into the sample well of the test cassette,
the specimen migrates by capillary action across the cassette. IgG
anti-dengue, if present in the specimen, will bind to the dengue
conjugates. The immunocomplex is then captured by the reagent
pre-coated on the T2 band, forming a burgundy colored T2 line,
indicating a dengue IgG positive test result and suggesting a
recent or repeat infection. IgM anti-dengue if present in the
specimen will bind to the dengue conjugates. The immunocomplex is
then captured by the reagent coated on the T1 line, forming a
burgundy colored T1 line, indicating a dengue IgM positive test
result and suggesting a fresh infection. Absence of any T lines (T1
and T2) suggests a negative result.
For NS1 Test
In this test procedure, anti-Dengue NS1 antibody is immobilized in
the test line region of the cassette. After a Whole Blood /Serum /
Plasma specimen is placed in the specimen well, it reacts with
anti-Dengue NS1 antibody coated particles that have been applied to
the specimen pad. This mixture migrates chromatographically along
the length of the test strip and interacts with the immobilized
anti-Dengue NS1 antibody. If the specimen contains dengue virus NS1
antigen, a colored line will appear in the test line region
indicating a positive result. If the specimen does not contain
dengue virus NS1 antigen, a colored line will not appear in this
region indicating a negative result.
To serve as a procedural control, a colored line will always appear
at the control line region indicating that proper volume of
specimen has been added and membrane wicking has occurred.
Storage and Stability
Store as packaged in the sealed pouch at room temperature or
refrigerated (4-30℃ or 40-86℉). The test device is stable through
the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Additional Special Equipment
Test devices Disposable specimen droppers
Buffer Package insert
Materials Required But Not Provided
Specimen collection containers
1.For professional in vitro diagnostic use only. Do not use after
2.Do not eat, drink or smoke in the area where the specimens and
kits are handled.
3.Handle all specimens as if they contain infectious agents.
4.Observe established precautions against microbiological hazards
throughout all procedures and follow the standard procedures for
proper disposal of specimens.
1.Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
2.Follow standard biosafety guidelines for handling and disposal of
potential infective material.
3.Humidity and temperature can adversely affect results.
Specimen Collection and Preparation
1.The Dengue NS1 Ag-IgG/IgM Combo Test can be performed used on
Whole Blood /Serum / Plasma.
2.To collect whole blood, serum or plasma specimens following
regular clinical laboratory procedures.
3.Testing should be performed immediately after specimen
collection. Do not leave the specimens at room temperature for
prolonged periods. For long term storage, specimens should be kept
below -20℃. Whole blood should be stored at 2-8℃ if the test is to
be run within 2 days of collection. Do not freeze whole blood
4.Bring specimens to room temperature prior to testing. Frozen
specimens must be completely thawed and mixed well prior to
testing. Specimens should not be frozen and thawed repeatedly.
Allow the test, specimen, buffer and/or controls to reach room
temperature 15-30℃ (59-86℉) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test device from the sealed pouch and use it as soon as
possible.Place the test device on a clean and level surface.
2. For IgG/IgM Test :Hold the dropper vertically and transfer 1
drop of specimen (approximately 10μl) to the specimen well(S) of
the test device, then add 2 drops of buffer (approximately 70μl)
and start the timer. See illustration below.
3. For NS1Test:
For serum or plasma specimen: Hold the dropper vertically and
transfer 8~10 drops of serum or plasma (approximately 100μl) to the
specimen well(S) of the test device, then start the timer. See
For whole blood specimens: Hold the dropper vertically and transfer
3 drops of whole blood(approximately 35μl) to the specimen well(S)
of the test device, then add 2 drops of buffer (approximately 70μl)
and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15
minutes. Do not interpret the result after 20 minutes.
Applying sufficient amount of specimen is essential for a valid
test result. If migration (the wetting of membrane) is not observed
in the test window after one minute, add one more drop of buffer or
specimen to the specimen well.
Interpretation of Results
For IgG/IgM Test: Control line and at least one test line appear on the membrane.
The appearance of T2 test line indicates the presence of dengue
specific IgG antibodies. The appearance of T1 test line indicates
the presence of dengue specific IgM antibodies. And if both T1 and
T2 line appear, it indicates that the presence of both dengue
specific IgG and IgM antibodies. The lower the antibody
concentration is, the weaker the result line is.
For NS1 Test: Two lines appear. One line should always appear in the control
line region(C), and another one apparent colored line should appear
in the test line region.
Negative: One colored line appears in the control region(C).No apparent
colored line appear in the test line region.
Invalid: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test device. If the problem persists, discontinue using the
test kit immediately and contact your local distributor.
1.The Dengue NS1 Ag-IgG/IgM Combo Test is for in vitro diagnostic
use only. The test should be used for the detection of dengue
antibodies and dengue virus NS1 antigen in Whole Blood /Serum /
Plasma specimens only.
2.As with all diagnostic tests, all results must be interpreted
together with other clinical information available to the
3.If the test result is negative and clinical symptoms persist,
additional testing using other clinical methods is recommended. A
negative result does not at any time preclude the possibility of
Dengue viral infection.
Span Biotech Ltd. is a research based company for rapid tests, with
strong support from National Key Laboratory of Technology Projects
of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University.
SpanBio also housed a R&D team that is developing gene
recombination, cell cultivation and protein purification
techniques. SpanBio pays strict attention on rapid tests for human
being, animal diseases and food safety detection. It provides a
number of customized services to professional distributors and
partnering affiliates with excellent quality, competitive prices
and super service.
1.Always best of all and always pay attention to innovation.
2.Special customized service tightly following customers’ requests.
3.Integrated excellent quality, competitive prices and super
Span Biotech Ltd.
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