Dengue NS1 Antigen Rapid Test
For the qualitative detection of Dengue NS1 Antigen in serum/plasma
and whole blood
Home Use Mosquito-Borne Infectious Disease Diagnostic Device For
Dengue NS1 Ag Rapid Test Kit
Intended Use
The Dengue NS1 Antigen Rapid Test is a qualitative test for the
detection of NS1 antigen of dengue virus in human serum or plasma..
Dengue fever is a worldwide health problem, and in epidemic
proportions in some countries.
The World Health Organization estimates that annually, 50-100
million people are infected worldwide with the dengue virus.Studies
have shown that early detection of Dengue NS1 virus using tests
like the Dengue NS1 Rapid test can help in early confirmation,
clinical treatment, and control of dengue viral infections.
This test is effective new diagnostic tools for early diagnosis of
dengue virus infection. The test is for In-Vitro Diagnostic use
only.
Principle
Serum, or plasma, samples may be used with this test. A sample is
dispensed on to the membrane The sample then migrates by capillary
action towards the test site where anti-Dengue antibodies are
immobilized. The NS1 antigen present in the sample will bind to the immobilized
Mab-anti-Dengue Antibodies immobilized in the test zone. on the
membrane. Next the sample buffer is applied which in turn
reconstitutes the dried Dengue gold anti-NS1 mouse antibody
conjugate.
The Dengue conjugate then migrates towards the test zone and binds
to Dengue NS1 antigen-Dengue Anti-NS1 antibodiy to form a complex
on the membrane as a separate red to blue lines if Dengue NS1
Antigens are present in the sample. The intensity of the test lines
will vary depending upon the amount of antigen present in the
sample.
The appearance of pink to dark blue line in the test region should
be considered as positive for NS1 antigen in the sample. There will
be a second control line on the membrane which will be invisible
until the test is run. It will show up as a red to blue control
line to indicate that the test is functioning properly.
Assay Procedure
All test cassettes, and specimens must be at room temperature (4-
300C) before running the assay procedure. Serum or plasma samples
should be used immediately after collection. The use of Icteric or
Lipemic samples should be avoided.
☀ Pipette 30 μl of serum or plasma,or 50 μl of whole blood into the
“S” well.
☀ Next dispense 2 drops of sample diluent buffer into the “S” well.
☀ Read the results between 15-20 minutes. Discard the test cassette
after 20 minutes. Do not read after 20 min.
Specimen Collection and Preparation
1. Whole blood specimen collection
☀ Whole blood is collected in syringe or evacuated tube containing
the anticoagulant.
☀ Whole blood specimens should be tested immediately after
collection. In the case of storing at 2-8°C, it should be tested
within 24 hours.
2. Plasma/Serum specimen collection
☀ Plasma or serum specimens should be tested immediately after
collection.
☀ Do not leave the specimens at room temperature for prolonged
period. Specimens may be stored at 2-8°C for up to 3days. For long
term storage, specimens should be kept below -20°C.
Specimens containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to
assay.
Interpretation of Results
Negative: The control line is the only line visible in the test zone. No NS1
antigens were detected. The result does not exclude dengue
infection.
Positive: The control line and the test line line is visible in the test
zone. The test is positive for NS1 antigens. This is indicative of
dengue infection.
Invalid: The test results are INVALID, if no control line is visible,
regardless of the presence or absence of line in the test zone of
the cassette.. Repeat the test using a new cassette.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for
the duration of the shelf life (24 months).
