Alere Determine, Syphilis RDT, kit/100

General Description:
Alere Determine, Syphilis TP, is a rapid immunochromatographic assay, for the qualitative indication of the presence of antibodies against Treponema pallidum.

Technical specifications:
Technology: Lateral flow immunochromatographic assay
Format: Strips, 100 tests
Sample type: Whole blood, serum, plasma
Sample volume: 50µl
Sensitivity: 100% (Plasma/Serum)
92.31% (whole blood)
Specificity: 100%
Time to result: 15 mins (up to 24 hours)

Manufacturer product reference: Alere Determine, 7D2443SET

Supplied as follows:
Test strips, 100
Chase buffer, 1 bottle
EDTA capillary tubes, 100
Lancets, 100

Items required, but not supplied:
Disposable gloves, sterile gauze, aldohol swabs, absorbent paper, protective glasses, timer, container for biohazard disposables and disinfectant (for surfaces)

Shelf life:
15 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.

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.