Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral chromatography)
Product details
Intended Use
Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral chromatography) is a lateral flow immunoassay intended for the rapid, qualitative detection of dengue IgG/IgM antibodies and dengue NS1 antigen in human serum, plasma, whole blood.
For In Vitro Diagnostic use only.
Test Principle
Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral chromatography) is based on immunochromatographic assay to detect dengue IgM/IgG antibodies and dengue NS1 antigens in human serum, plasma, whole blood. During the test， dengue IgM/IgG antibodies conjugate with dengue virus antigens labeled on colored spherical particles to form immune complex. Owing to capillary action, immune complex flow across the membrane. If the sample contains dengue IgM/IgG antibodies, it will be captured by the pre-coated test area and form visible test lines. Dengue NS1 antigens conjugate with dengue NS1 antibodies labeled on colored spherical particles to form immune complex. Owing to capillary action, immune complex flow across the membrane. If the sample contains dengue NS1 antigens, it will be captured by the pre-coated test area and form a visible test line.
To serve as a procedure control, a colored control line will appear if the test has been performed properly.
Main Contents
Components provided are listed in the table.
| Component REF | B035C-01 | B035C-25 |
| Test Cassette | 1 test | 25 tests |
| Sample Diluent | 1 bottle | 25 bottles |
| Dropper | 1 piece | 25 pcs |
| Disposable lancet | 1 piece | 25 pcs |
| Instructions For Use | 1 piece | 1 piece |
| Certificate of Conformity | 1 piece | 1 piece |
Operation Flow
Allow the test cassette, specimen and sample diluent to reach room temperature (15-30℃) prior to testing.
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.
2.1 For Serum or Plasma Specimens
Hold the dropper vertically, draw the specimen up to the lower Fill Line (approximately 10uL), and transfer the specimen to the specimen well (S) of the test cassette, then add 3 drops of sample diluent (approximately 80uL) and start the timer. Avoid trapping air bubbles in the specimen well(S). See illustration below.
2.2 For Whole Blood (Venipuncture/Fingerstick) Specimens
To use a dropper: Hold the dropper vertically, draw the specimen to the upper Fill Line and transfer whole blood (approximately 20uL) to the specimen well(S) of the test cassette, then add 3 drops of sample diluent (approximately 80 uL)and start the timer.See illustration below. To use a micropipette: Pipet and dispense 20uL of whole blood to the specimen well (S) of the test cassette, then add 3 drops of sample diluent (approximately 80uL) and start the timer. See illustration below.
3. Visually read the result after 10-15 minutes. The result is invalid after 15 minutes.
Result Interpretation
For Dengue IgM and IgG
1. Negative Result
The control line is only visible on the test cassette. It means that No IgG and IgM antibodies were detected and the result is negative.
2. Positive IgM and IgG Result
The control C line, IgM line and IgG line are visible on the test cassette. This is positive for both IgM and IgG antibodies. It is indicative of a late primary or early secondary dengue infection.
3. Positive IgG Result
The control C line, and IgG line are visible on the test cassette. This is positive for IgG antibodies. It is indicative of secondary or previous dengue infection.
4. Positive IgM Result
The control C line, and IgM line are visible on the test cassette. This is positive for IgM antibodies to dengue virus. It is indicative of a primary dengue infection.
5. Invalid Result
No visible colored band appears at control line after performing the test, the test result is invalid. Retest the sample
Result Interpretation
For Dengue NS1
1. Positive Result
If both the quality control C line and the detection T line appear, it indicatesthat the specimen contains detectable amount of NS1 antigen, and the result is positive for NS1 antigen.
2. Negative Result
If only the quality control C line appears and the detection T line does not show color, it indicates that NS1 antigen is not detectable in the specimen.
3. Invalid Result
No visible colored band appears at control line after performing the test, the test result is invalid. Retest the sample.
Order Information
| Product Name | Cat. No | Size | Specimen | Shelf Life | Trans. & Sto. Temp. |
| Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral chromatography) | B035C-01 | 1test/kit | S/P/WB | 18 Months | 2-30℃ / 36-86℉ |
| B035C-25 | 25 tests/kit |
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