The Dengue IgM ELISA is a qualitative test for the detection of IgM antibodies to dengue virus in human serum or plasma.
Advantage
1.Certificate:ISO13485:2003, GMP
2.Sensitivity>9/10
3.Specificity>14/15
4.Precision: CV<15%
Intended Use
The Dengue IgM ELISA is a qualitative test for the detection of IgM antibodies to dengue virus in human serum or plasma. This test is helpful for the determination of the primary dengue virus infection and is for In-Vitro Diagnostic use only.
KIT COMPONENTS
1. Microplate 1 plate (96 wells).
8 strips per plate, each with 12 wells coated with a mixture of purified recombinant Dengue 1-4 antigens.
2. Positive Control 1 vial (0.5ml).
Inactivated Human serum containing antibodies to Dengue antigens. Preservative: Bronidox (2ml/L).
3. Negative Control 1 vial (0.5ml).
Inactivated Human serum without antigens to Dengue antibodies. Preservative: Bronidox (2ml/L).
4. Conjugate 1 vial (6ml).
The solution contains HRP-labeled anti-human IgM (goat), with PBS(0.01mol/L) and stabilizing proteins, ready to use.
5. Sample Diluent 1 vial (30ml).
Contains stabilizing proteins and detergent, Preservative: Bronidox (2ml/L).
6. Wash Buffer (25) 1 vial (30ml).
Diluted 25-fold in distilled water as described in section of Preparation of Reagent.
7. Substrate Solution A 1 vial (6ml).
Hydrogen peroxide-urea (approx 0.6g/L) in citrate-acetate buffer solution (10 mmol/L).
8. Substrate Solution B 1 vial (6ml).
Tetramethyl benzidine dihydrochloride (10g/L).
9. Stop Solution 1 vial (6ml).
2N sulphuric acid.
10. Plate Covers 2 pieces.
11. Instruction Manual 1 booklet.
SPECIFIC PERFORMANCE CHARACTERISTICS
1. Sensitivity
Sensitivity could be detected in those samples which is converted by the weak positive blood serum with the incidence of DEN-I type just three days.
2. Specificity
Performance has been evaluated on blood donors samples (40 samples tested). The specificity calculated is 100%.
3. Precision
Assay reproducibility was determined by assaying the specimens in replicates of 10 using the same production lot. and the coefficient of variation (%CV) were calculated <15%.
