First Response Malaria Pf HRP2, kit/25

General Description:
First Response Malaria Ag Pf (HRP2), is a qualitative immuno-chromatographic test to diagnose the prescence of HRP2 antigen specific to P.f.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 25 tests
Sample type: Whole blood
Sample volume: 5µl
Panel detection score using Pf: 91.0%
False positive rate: 0.0%
Invalid rate: 0.0%
Reading time: 20 mins

Manufacturer product reference: Premier Medical Corporation, PI13FRC25.

Items supplied with:
1.Test device packed and sealed with 1 desiccant, 25
2.Buffer, 1 bottle
3.Blood transfer devices, 25
4.Alcohol swabs, 25
5.Sterile lancets, 25
6.Instruction for use, 1

Items required, but not supplied:
Disposable gloves, pen and timer, sharp disposable box and biohazardous waste container

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

Storage and transportation:
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

Weight and volume:
Estimated weight: 0.260 Kg
Estimated volume: 0.001 m³

General recommendations:
·For guidance on selection criteria for procurement of mRDTs, kindly refer to https://apps.who.int/iris/bitstream/handle/10665/259870/WHO-CDS -GMP-2018.01-eng.pdf?sequence=1
·Public reports of WHO prequalified in vitro diagnostic products can be found here: https://extranet.who.int/pqweb/vitro-diagnostics/prequali fication-reports/whopr
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).