Bioline Dengue Duo, kit/10

General description:
Bioline Dengue Duo test is an in vitro immunochromatographic, one step assay designed to detect dengue virus NS1 antigen, IgG and IgM antibodies to dengue virus in human serum, plasma or whole blood. Bioline Dengue Duo test contains two in vitro immunochromatographic assays for
analysis of dengue infection in human serum, plasma or whole blood (left side; Dengue NS1 Ag assay, right side; Dengue IgG/IgM assay).

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Cassette, 10 tests
Sample type: Whole blood, serum, plasma
Sample volume: NS1: 100µl, IgG/IgM: 10µl
Sensitivity: NS1: 92.4%, IgG/IgM: 94.2%
Specificity: NS1: 98.4%, IgG/IgM: 96.4%
Reading time: 15-20 mins

Manufacturer product reference:
Abbott Diagnostics Korea Inc., 11FK45

Items supplied with:
·Dengue NS1 Ag and Dengue IgG/IgM combo device, individually pouched including desiccants sachet, 10
·Assay diluent for Dengue IgG/IgM test (3ml), 1
·Capillary pipettes for Dengue IgG/IgM test (10μl), 10
·Disposable droppers for NS1 Ag test, 10
·Instructions for use, 1

Items required, but not supplied:
·Lancets and alcohol swab (for whole blood samples), plain/dry vacuum tube (for serum samples), EDTA vacuum tube (for plasma samples), 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:
24 months from the date of manufacturing; do not use beyond its expiry date.

Weight and volume:
Estimated weight: 0.243kg
Estimated volume: 0.0011m³

Storage and transportation condition:
The test kit should be stored at 1°C to 30°C, protect against humidity and direct sunlight. Do not freeze kit components.

Packaging and labeling:
Primary packaging: All contents of Bioline Dengue Duo, kit for 10 tests
Secondary packaging: One kit Bioline Dengue Duo, 10 tests


General recommendations:
·Only initiate testing when all components of the kit reach the temperature of the environment in which the test will be performed.
·Do not use the device if the pouch is damaged or the seal is broken.
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
·Do not substitute reagents from other kits/batches.