ParaHit Malaria Pf, kit/50

General Description:
ParaHIT Malaria Pf Ver. 1.0 (cassette) is in vitro qualitative immuno-chromatographic test for the detection of Pf specific HRP2 in human blood.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 50 tests
Sample type: Whole blood
Sample volume: 8µl
Panel detection score at low P.f. parasitemia: 84.9%
False positive rate: 0.0%
Invalidity rate: 0.0
Reading time: 25 mins
Manufacturer product reference: ARKRAY Healthcare,
55IC104-50.

Items supplied with:
1.Buffer, 1 bottle (12 ml)
2.Test devices, 50
3.Specimen transfer devices (single-use, disposable plastic pipettes), 50
4.Alcohol swabs, 50
5.Sterile lancets, 50
6.Instructions for use, 1

Items required, but not supplied:
Disposable gloves, timer, container for biohazard disposables and disinfectant (for surfaces)

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

Weight and Volume:
Weight: 0.700 kg
Volume: 2.92 dm3

Storage and transportation:
Between 4 - 40°C, protected against humidity and direct sunlight. Do not freeze reagents

Packaging and labeling:
Primary packaging: All contents of ParaHIT Malaria Pf Ver. 1.0 cassette, kit for 50 tests
Secondary packaging: One kit ParaHIT Malaria Pf Ver. 1.0 cassette, 50 tests

General recommendations:


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)