SD Bioline,syphilis RDT,3.0, kit/30

General description:
SD Bioline, Syphilis 3.0, is a rapid immunochromatographic assay, for the qualitative indication of the presence of antibodies (IgG, IgA, IgM) against Treponema pallidum.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Cassette, 30 tests
Sample type: Whole blood, serum, plasma
Sample volume: 20µl (whole blood), 10μl (serum, plasma)
Sensitivity: 99.3%
Specificity: 99.5%
Time to result: 5 - 20 mins

Manufacturer product reference: Standard Diagnostics, 06FK10

Items supplied with:
·Test devices with desiccant in an individual foil pouch, 30
·Assay diluent, 1 x 4 ml/vial
·Blood transfer devices, 30
·Sterile non-safety lancets, 30
·Alcohol swabs, 30
·Instructions for use

Items required, but not supplied:
·Plain/dry vacuum tube (for serum samples), EDTA vacuum tube (for plasma samples), vacuum tube needle, needle holder, and centrifuge.
·Disposable gloves, sterile gauze, antiseptic swabs, absorbent paper, protective glasses, timer, a container for biohazard disposables, and disinfectant (for surfaces).

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

Storage and transportation:
Between 2 - 30°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and Labeling:
Primary packaging: All content of SD Bioline, syphilis RDT,3.0, kit of 30 tests
Secondary packaging: One kit SD Bioline, syphilis RDT,3.0, kit/30 tests

Weight and volume:
Estimated weight: 0.283 Kg
Estimated volume: 0.001638 dm³

General recommendations:
·Only initiate testing when all components of the 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.