Dengue IgM Capture ELISA, kit/96

General Description:
Dengue IgM Capture ELISA, is an enzyme-linked immunosorbent assay for the qualitative detection of IgM antibodies specific to dengue virus. The reactive samples should be confirmed by a supplemental assay such as RT-PCR or HI (hemagglutination inhibition).

Technical specifications:
Technology: Enzyme Immunoassay
Format: Microtitre plate, 96 tests
Sample type: Serum
Sample volume: 10µl
Sensitivity: 96.4%
Specificity: 98.9%
Time to result: 2 hrs 10 mins

Manufacturer product reference: Standard Diagnostics, Inc., 11EK20.

Items supplied with:
1.Coated wells: 1 plate of 96 microwells
2.Dengue Antigen, 4 vials (60μg)
3.Sample Diluent, 2 vials (50ml)
4.Mouse Monoclonal Anti-Dengue IgM Conjugate (2 X), 1 vial (10ml)
5.Conjugate Diluent, 1 vial (10ml)
6.Positive Control, 1 vial (0.2ml)
7.Negative Control, 1 vial (0.2ml)
8.Working TMB, 1 vial (15ml)
9.Washing Solution (20X), 1 vial (50ml)
10.Stopping Solution, 1 vial (20ml)
11.Adhesive plate sealer, 3
12.Instructions for use

Items required, but not supplied:
1.Precision micropipette and disposable tips, automated plate washer (optional) or suitable equipment for washing 8 microwell strips, spectrophotometer or ELISA plate reader able to read a 96 microwell plate of 8 microwell strips at an absorbance of 450nm with a reference at 620nm (optional) and icubator capable of maintaining temperature at 37±1°C.
2.For serum samples: Plain/dry vacuum tube, vacuum tube needle, needle holder and centrifuge.
3.Disposable gloves, anti-septic swabs, absorbent paper, protective glasses, timer, container for biohazard disposables and disinfectant (for equipment and surfaces).

Shelf life:
18 months from the date of manufacturing; do not use beyond its expiry date.

Storage and transportation:
Between 2-8°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: 1 plate of 96 wells from Dengue IgM Capture ELISA, accessories and instructions for use, must be contained in one kit.

Weight and volume:
Estimated weight: 0.58Kg
Estimated volume: 0.002816m³

General recommendations:
1.Only initiate testing when all components of kit reach the temperature of the environment in which the test will be performed.
2.Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
3.Do not substitute reagents from other kits/batches.
4.Note that serum or plasma samples require supporting equipment and supplies, therefore a laboratory environment is recommended with adequately trained staff.