ParaHIT Malaria Pf cassette, kit/10

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, 10 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,
55IC104-10.

Items supplied with:
1.Buffer, 1 bottle (2.5 ml)
2.Test devices, 10
3.Specimen transfer devices (single-use, disposable plastic pipettes), 10
4.Alcohol swabs, 10
5.Sterile lancets, 10
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: 0.135 kg
Volume: 0.74 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 10 tests
Secondary packaging: One kit ParaHIT Malaria Pf Ver. 1.0 cassette, 10 tests

General recommendations:
·For guidance on selection criteria for procurement of mRDTs, kindly refer to https://apps.who.int/iris/bitstream/hand le/10665/259870/WHO-CDS-GMP-2018.01-eng.pdf
·Public reports of WHO prequalified in vitro diagnostic products can be found here: https://www.who.int/diagnostics_l ab oratory/evaluations/pq-list/malaria/public_report/en/
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).