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One Step Dengue NS1 Ag Test (Whole Blood/Serum/Plasma) FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY Intended Use The One Step Dengue NS1 Ag Test is a rapid chromatographic immunoassay for the qualitative
detection of dengue virus NS1 antigen in Whole Blood /Serum / Plasma to aid in the diagnosis of
Dengue viral infection.
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 Whole Blood/serum/plasma. The test is based on immunochromatography and can give
a result within 15 minutes.
Principle The One Step Dengue NS1 Ag Test is a qualitative membrane strip based immunoassay for the
detection of dengue virus NS1 antigen in Whole Blood /Serum / Plasma. In this test procedure,
anti-Dengue NS1 antibody is immobilized in the test line region of the device. 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 Materials Provided  Test devices  Disposable specimen droppers  Buffer (for whole blood only)  Package insert Materials Required But Not Provided  Timer  Centrifuge  Specimen collection containers Precautions  For professional in vitro diagnostic use only. Do not use after expiration date.  Do not eat, drink or smoke in the area where the specimens and kits are handled.  Handle all specimens as if they contain infectious agents.  Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.  Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.  Follow standard biosafety guidelines for handling and disposal of potential infective material.  Humidity and temperature can adversely affect results. Specimen Collection and Preparation 1. The One Step Dengue NS1 Ag 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. 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
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IDN-402-G1.0
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 specimens.
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.
Test 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 possible.
2. Place the test device on a clean and level surface.
3. For serum or plasma specimen: 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. For whole blood specimens: Hold the dropper vertically and transfer 1 drop 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. 5. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the
result after 20 minutes.
Notes:
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
(for whole blood) or specimen (for serum or plasma) to the specimen well. Interpretation of 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. Limitations 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 Whole Blood /Serum / Plasma
specimens only. Neither the quantitative value nor the rate of increase in dengue virus
NS1 antigen can be determined by this qualitative test.
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 physician.
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.