Test Format: Strip/CassetteSpecimen: Whole Blood/Serum/PlasmaExpiry date: 24 MonthsFunction: Rapid testStorage: 2-30 centigradeCertificate: CE
CE Certificate IVD Dengue Ab IgM/IgG Detect Rapid Test kit Quickly Diagnostic Dengue AbTest card
I
IVD Rapid Diagnostic Dengue Ab Test Kit Dengue IgM/IgG Antibody | |
Format | Cassette |
Specimen | Whole Blood /Serum / Plasma |
Specification | 4.0mm for your designed |
Accuracy | 99% |
Read time | within 15 min |
Shelf life | 24 months |
Intended Use
One Step Dengue IgG/IgM Whole Blood/Serum/Plasma Test cassette is an immunochromatographic assay designed for the qualitative detection and differentiation of specific IgM and IgG antibodies to dengue virus in human whole blood, serum or plasma. The test provides a differential detection of anti-dengue IgM and anti-dengue-IgG antibodies and can be used for the presumptive distinction between a primary and secondary dengue infection. The results obtained should not be the sole determinant for clinical decision.
For in vitro diagnostic use only. For professional use only.
Specimen Collection And Preparation
The test can be performed with either serum or plasma or whole blood.
Test Procedure
Allow test device, specimen, and/or controls to equilibrate to room temperature(15-30°C) 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.
For Serum or Plasma Specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5μL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80μL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S)
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line. and transfer 1 drop of whole blood (approximately 10μL) to the specimen well (S) of the test device, thenadd 2 drops of buffer(approximately 80μL) and start the timer. See illustration below.
To use a micropipette: Pipet and dispense 10 μL of Whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 10μL) and start the timer. See illustration below.
3.Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
POSITIVE
IgG positive: Coloured bands appear at the control line (C) and test line T1. The test is positive for IgG antibodies. This is indicative of a secondary dengue infection.
IgM positive: Coloured bands appear at the control line (C) and test line T2. The test is positive for IgM antibodies. This is indicative of a primary dengue infection.
Both IgG and IgM positive: Coloured bands appear at the control line (C) and test lines T1 and T2. The test is positive for IgG and IgM antibodies. This is indicative of a secondary dengue infection.
NEGATIVE
Only control line (C) is visible. No IgG or IgM antibodies were detected. The result does not exclude dengue infection. If symptoms persist, a new sample should be drawn from the patient in 3-5 days and then should be retested
INVALID
If the color band (“C”) is not visible within the result window after performing the test, the result is considered invalid. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested.
1.factory direct price with good quality
2.CE,ISO13485,SFDA approved and GMP standard
3.professional OEM sevice available
4. promote delivery at any port of China
5.free samples can be provided for your reference
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