First Response Malaria Pf HRP2, kit/25

General description:
First Response Malaria Antigen P. falciparum (HRP2) Card Test is intended to be performed by trained users (in either laboratory and point of care settings) as qualitative screening in vitro diagnostic test for detection of P. falciparum specific HRP2 antigens. The test is intended for use with human whole blood specimens (capillary or venous blood).

Technical specifications:
Sample type: Whole blood (capillary or venous blood)
Sample volume: 5µl
Panel detection score using Pf: 91.0%
False positive rate: 0.0%
Invalid rate: 0.0%
Reading time: 20-30 mins

Manufacturer product reference:
Premier Medical Corporation, India. PI13FRC25
QMS/Regulatory information:
•ROW (Rest-of-World)
•ISO 13845:2016
•WHO Pre-Qualified product

Items supplied with:
•25 x Test device pouch containing: 1 test device and 1 desiccant
•1 x Assay buffer bottle
·25 x Specimen transfer devices (Manufacturer: Precision Medical Device Industries, India)
•25 x Alcohol swabs (Manufacturer: Medtrue Enterprise Co., Ltd. China - CE Marked)
•25 x Sterile non-safety lancets (Manufacturer: Shandong Lianfa Medical Plastics Products Co Ltd, China - CE Marked)
•1 x IFU

Items required, but not supplied:
Disposable gloves, pen and 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: 0.240kg
Estimated volume: 0.0102m³

Storage & transportation condition:
The test kit should be stored at 1-40°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of First Response Malaria Ag Pf (HRP2), kit for 25 tests
Secondary packaging: One kit First Response Malaria Ag Pf (HRP2), 25 tests

General recommendations:
•For guidance on selection criteria for procurement of mRDTs
•Public reports of WHO prequalified in vitro diagnostic products
•Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).