Determine Syphilis TP with accs,kit/100

General description:
Determine Syphilis TP is an in vitro, visually read, qualitative immunoassay for the detection of antibodies to Treponema pallidum, which is the bacteria that causes syphilis infection, in human capillary and venous whole blood, plasma or serum. The test is intended as an aid to detect antibodies to Treponema pallidum from infected individuals. The test is for professional use only.

Technical specifications:
Sample type: Whole blood, serum, plasma
Sample volume: 50µl
Sensitivity: 100%
Specificity: 98.7%
Reading time: 15 to 30 mins

Manufacturer product reference:
Abbott Diagnostics Medical Co., Ltd., Japan. 7D2453SET
QMS/Regulatory information:
ROW (Rest-of-World)
ISO 13845:2016
WHO Pre-Qualified product

Items supplied with:
10 x 10 Tests per card
1 x Chase buffer bottle (2.5ml)
100 x EDTA capillary tubes (Manufacturer: Drummond Scientific Co., USA)
100 x Sterile non-safety lancets (Manufacturer: Tianjin Huahong Technology Co., Ltd., China - CE Marked)
1 x IFU

Items required, but not supplied:
Disposable gloves, timing device, alcohol swab and gauze pad, micropipette capable of delivering 50 μL (not required for fingerstick method), single-use sterile lancet (for fingerstick method)

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

Weight and volume:
Estimated weight: 0.333kg
Estimated volume: 2.105dm3

Storage condition:
The test kit should be stored at 2°C to 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All content of Determine Syphilis TP with accessories, kit for 100 tests
Secondary packaging: One kit Determine Syphilis TP with accessories, 100 tests

General recommendations:
https://extr anet.who.int/prequal/sites/default/files/whopr_files/PQDx_0485-013-00_DetermineSyphilisTPP_v1.0.pdf
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).