Dengue NS1 Ag INTENDED USE
The One Step Dengue NS1 Ag Test is a rapid chromatographic immunoassay for the qualitative
detection of dengue virus NS1 antigen in serum or plasma to aid in
the diagnosis of Dengue viral infection.
Dengue NS1 Ag SUMMARY
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 NS1 Ag Test
is a simple, visual qualitative test that detects dengue virus NS1
antigen in human serum or plasma. The test is based on
immunochromatography and can give a result within 15 minutes.
PRINCIPLE OF THE PROCEDURE
The One Step Dengue NS1 Ag Test is a qualitative membrane strip based immunoassay for the
detection of dengue virus NS1 antigen in serum or plasma. In this
test procedure, anti-Dengue NS1 antibody is immobilized in the test
line region of the device. After a Serum or 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
REAGENTS AND MATERIALS SUPPLIED
· Test cards/ test strips individually foil pouched with a
· Sample diluent
· Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
· Specimen Collection Containers
RAGE AND STABILITY
1. Store unused kit at 2 - 30°C.
2. Store test cards/strips at 2 - 30°C and away from direct
WARNINGS AND PRECAUTIONS
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 y infective material.
7. Humidity and temperature can adversely affect results
SAMPLE COLLECTION AND PREPARATION
1. The One Step Dengue NS1 Ag Test can be performed used on Serum or plasma.
2. To collect whole blood, serum or plasma specimens following
regular clinical laboratory procedures.
3. Separate serum or plasma from blood as soon as possible to avoid
hemolysis. Use only clear non-hemolyzed specimens.
4. Testing should be performed immediately after specimen
collection. Do not leave the specimens at room temperature for
prolonged periods. Serum and plasma specimens may be stored at 2-8℃
for up to 3 days. For long term storage, specimens should be kept
5. 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.
Dengue NS1 Ag ASSAY PROCEDURE
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
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 3 drops of serum or
plasma (approximately 100μl) to the specimen well(S) of the test
device, then 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
NOTE: 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 specimen
(serum or plasma) to the specimen well.
READING THE TEST RESULTS
Positive: 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.
Specificity and Sensitivity
1. The One Step Dengue NS1 Ag Test has been evaluated with specimens obtained from a population
of symptomatic individuals who presented for examination. The
result shows that the sensitivity of the One Step Dengue NS1 Ag
Test is 90.0% and the specificity is 99.6% compared to actual
2. The analytical sensitivity of the Dengue NS1 Ag Rapid Test is
LIMITATIONS OF THE TEST
1. The One Step Dengue NS1 Ag Test is for in vitro diagnostic use only. The test should be used
for the detection of dengue virus NS1 antigen in Serum or plasma
specimens only. Neither the quantitative value nor the rate of
increase in dengue virus NS1 antigen can be determined by this
2. The One Step Dengue NS1 Ag Test will only indicate the presence of dengue virus NS1 antigen
in the specimen and should not be used as the sole criteria for the
diagnosis of dengue virus infection.
3. As with all diagnostic tests, all results must be interpreted
together with other clinical information available to the
4. 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 virus infection.
Contact Rebecca Yan