Panbio Dengue Early ELISA, kit/96

General description:
Panbio Dengue Early ELISA, is a test for the qualitative detection of NS1 antigen (serotypes 1, 2, 3, 4) in serum, used as an aid in the clinical laboratory diagnostics of patients with clinical symptoms consistent with dengue fewer.

Technical specifications:
Technology: Enzyme-linked immunosorbent assay
Format: Microtitre plate, 96 tests
Sample type: Serum
Sample volume: 75µl
Performance characteristics:
Study site 1: (Vietnam)
Sensitivity: 77.7%
Specificity: 93.6%
Study site 2: (Thailand)
Sensitivity: 76.0%
Specificity: 98.4%

Manufacturer product reference: Abbott Diagnostics Korea Inc., 01PE40

Items supplied with:
·Antibody coated microwells, 1 plate of 96 microwells
·HRP Conjugated antibody, 1 bottle (15 ml)
·Wash Buffer (20x), 1 bottle (60 ml)
·Sample Diluent, 1 bottle (22 ml)
·TMB Chromogen (TMB), 1 bottle (15 ml)
·Positive Control, 1 vial (1.2 ml)
·Calibrator, 2 vials (1.5 ml)
·Negative Control, 1 vial (1.2 ml)
·Stop Solution, 1 bottle (15 ml)
·IFU, 1

Items required, but not supplied:
·Accurate adjustable micropipettors with disposable pipette tips (5-1000 μL capacity), deionised water, microplate washing system, microplate reader with 450 nm filter, graduated cylinder, flask and test tubes or microtitre plate for serum dilutions, glass or plastic tubes or vials for diluting antigen.
·For serum samples: Plain/dry vacuum tube, vacuum tube needle, needle holder and centrifuge.
·Disposable gloves, anti-septic swabs, absorbent paper, protective glasses, timer, container for biohazard disposables and disinfectant (for equipment and surfaces).

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

Weight and volume:
Estimated weight: 0.39 Kg
Estimated volume: 0.00263 m³

Storage and transportation condition:
The kit must be stored at 2°C to 8°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of Panbio Dengue Early ELISA, kit for 96 tests
Secondary packaging: One kit Panbio Dengue Early ELISA, 96 tests

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