ParaHIT Malaria Pf cassette, kit/25

General description:
ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Device is a simple, rapid and an in vitro qualitative screening test for the detection of Plasmodium falciparum specific HRP–II (Histidine-rich protein II) in human blood.

Technical specifications:
Sample type: Whole blood
Sample volume: 8µl
Pf panel detection score: 84.9%
False positive rate: 0.0%
Invalidity rate: 0.0%
Reading time: 25-30 mins

Manufacturer product reference: Arkray Healthcare Private Limited., India.
55IC104-25

QMS/Regulatory information:
·CE Marked
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·25 x Test device pouch containing: 1 test device, 1 desiccant
·25 x Disposable plastic pipettes (Manufacturer: Nav Durga Plastic Industries, India)
·1 x Reaction buffer bottle (6.0ml)
·25 x Sterile non-safety lancets (Manufacturer: Promisemed Hangzhou Meditech Co., Ltd, China - CE Marked)
·25 x Alcohol swabs (Manufacturer: MAK Medicals Pvt. Ltd., India)
·1 x IFU

Items required, but not supplied:
Disposable gloves, pen/pencil, timer,sharp container, biohazard disposable container

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

Weight and Volume:
Weight: 0.275kg
Volume: 0.002m3

Storage & transportation condition:
The test kit should be stored at 4°C to 40°C, protect 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 25 tests
Secondary packaging: One kit ParaHIT Malaria Pf Ver. 1.0 cassette, 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).