Dengue IgG/IgM Rapid Test Uncut Sheets
SAMPLE: Whole Blood / Serum / Plasma
FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY
The One Step Dengue IgA/IgG/IgM Test is a rapid chromatographic
immunoassay for the qualitative detection of antibodies (IgA, IgG
and IgM) 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. One step Dengue IgA/IgG/IgM
Test is a simple, visual qualitative test that detects dengue virus
antibodies in human Whole Blood/serum/plasma. The test is based on
immunochromatography and can give a result within 15 minutes.
The One Step Dengue IgA/IgG/IgM Test is a qualitative membrane
strip based immunoassay for the detection of dengue virus
antibodies (IgA, IgG and IgM) in Whole Blood /Serum / Plasma. 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 three test lines (T1, T2and T3 lines) and a
control line (C line). The T1 line is pre-coated with the antibody
for the detection of IgA anti-dengue, The T2 line is pre-coated
with the antibody for the detection of IgM anti-dengue, T3 line is
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 T3 band, forming a burgundy colored T3
line, indicating a dengue IgG positive test result. 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 T2
line, forming a burgundy colored T2 line, indicating a dengue IgM
positive test result. IgA 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 IgA positive test result.
Absence of any T lines (T1, T2and T3 lines) suggests 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
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
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.
5.Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
6.Follow standard biosafety guidelines for handling and disposal of
potential infective material.
7.Humidity and temperature can adversely affect results.
Specimen Collection and Preparation
1.The One Step Dengue IgA/IgG/IgM 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
within 2 days of collection. Do not freeze whole blood specimens.
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.