FirstResponseHIV1+2/SyphComboCard,kit/50

General description:
First Response HIV 1+2 / Syphilis Combo Card Test is a rapid, qualitative screening, in vitro diagnostic test for the detection of antibodies (IgG & IgM) specific to HIV (type 1 & 2) and Treponema pallidum in human serum, plasma or venous and capillary whole blood. The test can be used as an aid in diagnosis of HIV and/or Syphilis. It is intended for use by healthcare professionals and trained users.

Technical specifications:
Sample type: Whole blood, serum, plasma
Sample volume: 20μl
Sensitivity: 100.00% (HIV 1/2), 99.00% (Syphilis)
Specificity: 99.50% (HIV 1/2), 100.00% (Syphilis)
Time to result: 15 - 25 mins

Manufacturer product reference:
Premier Medical Corporation Pvt Ltd., India. I20FRC50

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 non-safety lancets (Manufacturer: Shandong Lianfa Medical Plastic Products Co Ltd., China - CE Marked)
·50 x Alcohol swab (Manufacturer: Medtrue Enterprise Co., Ltd. China - CE Marked)
·1 x IFU

Items required, but not supplied:
Disposable protective gloves, marker pen, timer, extra lancets and alcohol swabs if needed, biohazard waste container and sharp disposable box, sterile gauze pads, 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: 0.46kg
Estimated volume: 0.0018m3

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

Packaging and labeling:
Primary packaging: All contents of First Response HIV1+2/Syphilis Combo Card for 50 tests
Secondary packaging: One kit First Response HIV1+2/Syphilis Combo Card, 50 tests

General recommendations:
https://extranet.who.int/prequal/sites/default/files/whopr_files/PQDx_03 64-010-00_FirstResponse_HIV1-2SyphilisComboCardTest_v3.0.pdf

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