FirstResponseSyph Anti-TPCardTest,kit/50

General description:
First Response Syphilis Anti-TP Card Test is a rapid, qualitative, screening, in vitro diagnostic test for the detection of antibodies of all classes specific to Treponema pallidum in human serum, plasma or venous or capillary whole blood. It is intended for use by healthcare professionals and qualified laboratory personnel. The test can be used as an aid in the diagnosis of Syphilis infection.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Cassette, 50 tests
Sample type: Whole blood, serum, plasma
Sample volume: 20µl
Sensitivity: 99.6%
Specificity: 100%
Reading time: 20 mins

Manufacturer product reference:
Premier Medical Corporation Private Limited., India. PI08FRC50

QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·50 x Test device pouch containing: 1 test device, 1 desiccant
·2 x Assay buffer bottle (2.5ml)
·50 x Specimen transfer device (Manufacturer: V2 Manufacturers, India)
·50 x Sterile twist lancets (Manufacturer: Shandong Lianfa Medical Plastic Products Co., Ltd., China)
·50 x Alcohol swabs (Manufacturer: Medtrue Enterprise Co., Ltd., China)
·1 x IFU

Items required, but not supplied:
New pair of protective gloves, sterile gauze pad and tissue paper, permanent marker pen, timer, Sharp disposable box and biohazardous waste container, Venipuncture blood collection kit (if whole blood is collected by venipuncture)

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

Weight and volume:
Estimated weight: 0.48kg
Estimated volume: 0.002m3

Storage condition:
The test kit should be stored at 4°C to 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All content of First Response Syphilis Anti-TP Card Test, kit for 50 tests

Secondary packaging: One kit First Response Syphilis Anti-TP Card Test, 50 tests


General recommendations:
PQDx_0471 -010-00_FirstResponseSyphilis_v2.0.pdf (who.int)

Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).