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- One-Step Dengue IgG/IgM Rapid Test(Guangdong)
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PrintProduct Name: One-Step Dengue IgG/IgM Rapid Test 
Product Categories: Medical Equipment Manufacturing Equipment Post Date: Mar 28,2016 Expiry Date: Mar 28,2017 Description: Payment Method: T/T,Western union
NEUTRAL PACKING: spanbio
NegotiableUSD/Metric Tons
Dengue IgG/IgM INTENDED USE
THE ONE STEP ANTI-DENGUE (IGM & IGG) TRI-LINE TEST IS A
COLLOIDAL GOLD ENHANCED, RAPID IMMUNOCHROMATOGRAPHIC ASSAY
FOR THE QUALITATIVE DETECTION OF ANTIBODIES (IGM & IGG) TO
DENGUE VIRUS (DV) IN HUMAN WHOLE BLOOD, SERUM OR PLASMA.
THIS TEST IS A SCREENING TEST, AND ALL POSITIVES MUST BE
CONFIRMED USING AN ALTERNATE TEST SUCH AS WESTERN BLOT. THE
TEST IS INTENDED FOR HEALTHCARE PROFESSIONAL USE ONLY.
Dengue IgG/IgM SUMMARY
Dengue viruses (DVs) are the causative agent of dengue
fever, dengue hemorrhagic fever and dengue shock syndrome.
It is estimated that at least 80 million DV infections occur
worldwide annually. The majority of DV infections are
asymptomatic. In symptomatic DV infection, clinical
syndromes range from an undifferentiated febrile illness to
dengue fever (DF) to dengue hemorrhagic fever (DHF), a
plasma leakage syndrome that, in its most severe form dengue
shock syndrome (DSS) can be life threatening.
PRINCIPLE OF THE PROCEDURE
The assay starts with a sample applied to the sample well.
A recombinant DV antigen conjugated to colloidal gold
embedded in the sample pad reacts with the DV antibody
present in blood, serum or plasma forming conjugate-DV
antibody complex. As the mixture is allowed to migrate
along the test strip, the conjugate-DV antibody complex is
captured by mouse anti human IgM-µ chain (T1) or mouse anti
human IgG(T2) immobilized on a membrane forming a colored
test line in the test region. A negative sample does not
produce a test line due to the absence of colloidal gold
conjugate-DV antibody complex. The antigens used in the
conjugate test are recombinant proteins that correspond to
highly immunoreactive regions of DV. A colored control line
in the control region appears at the end of test procedure
regardless of test result. This control line is the result
of colloidal gold conjugate binding to the anti-DV antibody
immobilized on the membrane. The control line indicates that
the colloidal gold conjugate is functional.
Two test lines are coated on the membrane; on T1 region
mouse anti human IgM-µ chain is immobilized; On T2 region a
mouse anti human IgG is coated, a positive result appearing
on T1 region indicates a DV IgM positive samples and a
positive result appearing on T2 region indicates a DV IgG
positive samples.
REAGENTS AND MATERIALS SUPPLIED
· Test cards/ test strips individually foil pouched
with a desiccant
·Sample diluent
·Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
·Pipettes to transfer specimen.
· Positive and negative controls
STORAGE AND STABILITY
1.Store unused kit at 2 - 30°C.
2.Store test cards/strips at 2 - 30°C and away from direct
sunlight.
WARNINGS AND PRECAUTIONS
All positive results must be confirmed by an alternate
method.
1.Treat all specimens as though potentially infectious. Wear
gloves and protective clothing when handling specimens.
2.Devices used for testing should be autoclaved before
disposal.
3.Do not use kit materials beyond their expiration dates.
4.Do not interchange reagents from one kit lot to another.
SAMPLE COLLECTION AND STORAGE
Whole Blood:
1.Collect whole blood specimens following regular clinical
laboratory procedures.
2.Heparinized capillary tubes treated with anticoagulant
must be used for collecting blood samples.
3.Whole blood specimens should be used immediately after
collection.
Serum or Plasma:
1.Collect serum or plasma specimens following regular
clinical laboratory procedures.
2.Storage: A specimen should be refrigerated if not used the
same day of collection. Specimens should be frozen if not
used within 3 days of collecting. 0.1% of sodium azide can
be added to specimen as preservative without affecting the
results of the assay.
ASSAY PROCEDURE
Do not open pouch until you are ready to test the sample.
1.Bring all reagents and specimens to room temperature.
2.Remove the test card from the foil pouch and place on a
clean dry surface.
3.Identify the test card for each specimen or control.
4.Dispense one drop (1ml) of the specimen or control into
the â€S†well on the card, then add two drops of sample
diluent into theâ€D†well.
5.Interpret test results at 15 minutes.
Caution: Use a clean pipette or tip for every sample to
avoid cross-contamination.
NOTE: A positive result may be interpreted early, however
read any negative at 15 minutes to ensure sample is negative
and not a low concentration of the anti-DV antibody. Do not
interpret the result after 20 minutes.
It is recommended to run a known positive control and
negative control in each performance to ensure the assay
procedure.
READING THE TEST RESULTS
1. Positive: Control line and at least one test line
appear on the membrane. The appearing of T1 test line
indicates a DV IgM positive result, the appearing of T2
test line indicates a DV IgG positive result, the appearing
of both T1 and T2 test lines indicate both DV IgM & IgG
positive result. The lower the antibody concentration is,
the weaker the test line is.
2. Negative: Only the control line appears on the
membrane. The absence of a test line indicates a negative
result.
3. Invalid: There should always be a control line in the
control region regardless of test result. If control line
is not seen, the test is considered invalid. Repeat the test
using a new test device.
Note: It is normal to have a slightly lightened control line
with very strong positive samples as long as it is
distinctly visible.
PERFORMANCE CHARACTERISTICS
1. Specificity
In an in-house laboratory study, 63 confirmed negative
samples were evaluated with Advanced Quality One Step Anti-
Dengue (IgM & IgG) Tri-line Test using EIA and Western Blot
as reference tests. The study gave 100% specificity for the
test.
2. Sensitivity
In the above-mentioned study, Advanced Quality One Step
Anti-Dengue (IgM & IgG) Tri-Line Test was evaluated with 32
confirmed positive samples. The sensitivity of Advanced
Quality One Step Anti-Dengue (IgM & IgG) Tri-line Test was
found to be 100% relative to consensus with EIA results,
supported by Western Blot assay.
WARNINGS
1. Only samples that are not hemolyzed and that are
with good fluidity can be used in this test.
2. Fresh samples are best but refrigerated and frozen
samples can be used.
3. Do not agitate the sample. Insert a pipette just
below the surface of the sample to collect the specimen.
LIMITATIONS OF THE TEST
Although a positive result may indicate infection with
dengue virus, a diagnosis of DV can only be made on clinical
grounds, if an individual meets the case definition for DV
established by the Centers for Disease Control. For samples
repeatedly tested positive, more specific supplemental tests
must be performed. Immunochromatographic testing alone
cannot be used to diagnose DV even if the antibodies against
DV are present in a patient specimen. A negative result at
any time does not preclude the possibility of DV infection.
Contact Rebecca Yan
Skype: span.biotech
Email: rebecca@spanbio.com
anna.lee@spanbio.com
Tel: +86(755)89589611
Fax: +86(755)89580096
Web:www.spanbio.com
www.spanbiotech.com
Company: Span Biotech Ltd. [ Guangdong ] Address: Room 6A,Unit 5, Building 3, Sunshine Aloha, Bantian Industrial Park, Banxuegang Road ,Longgang Shenzhen Contact: Rebecca Yan Tel: 0755-89589611 Mobile: Fax: 0755-89580096 Email: rebecca@spanbio.com Disclaimer statement:The information and data included above have been realized by the enterprises and compiled by Department staff, and are subject to change without notice to you. The ChinameDevice.com makes no warranties or representations whatsoever regarding the facticity, accuracy and validity of such information and data. Our suggestion: In order to ensure your interest, we suggest registering as our gold suppliers.
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