Product Details

Product Description

[PRINCIPLE]

The Dengue NS1 Antigen Rapid Test Cassette/Strip is an immunoassay based on the principle of the double antibody-sandwich technique. During testing, anti-Dengue antibody is immobilized in the test line region of the device. After a Whole Blood/Serum/Plasma specimen is placed in the device. After a Whole Blood/Serum/Plasma specimen is placed in the specimen well, it reacts with anti-Dengue 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 antibody. If the specimen contains dengue virus antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain dengue virus antigen, a colored line will not appear in this region indicating a negative result.

To serve as a 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.

[SPECIMEN]

●The dengue test can be used to test Whole Blood/Serum/Plasma specimens.

●Collect blood specimen (containing EDTA, citrate or heparin) by vein puncture following standard laboratory procedures.

●Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.

●Store specimens at 2-8℃ (36-46℉) if not tested immediately. Store specimens at 2-8℃ up to 7 days. The specimens should be frozen at -20℃ (-4℉) for longer storage. Do not freeze whole blood specimens.

●Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.

●Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

[For Cassette]

1.Remove the test cassette from the sealed pouch and use it as soon as possible.

2. Place the test cassette 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 100ul) to the specimen well (S) of the test cassette, then start the timer.

4.For whole blood specimens: Hold the dropper verically and transfer 1 drop of whole blood(approximately 35ul) to the specimen well(S) of the test cassette, then add 2 drops of buffer (approximately 70ul) and start the timer.

5.Wait for the colored line(s) to appear. Read resuts at 15 minutes. Do not interpret the result after 20 minutes.

[INTERPRETATION OF RESULTS]

Positive:*Two lines appear. One colored line should be in the controlregion (C), and another apparent colored line adjacent should be in the test region (T). This positive result indicates the presence of antigens to Dengue.

Negative: One colored line oppears in the control region (C). No line appears in the test region (T). This negative result indicates the absence of antigens to Dengue.

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 using a new test cassette/strip. If the problem persists, discontinue using the lot immediately and contact your local distributor.