OneStep MERISCREEN Mal Pf/Pan Ag, kit/25

General description:
MERISCREEN Malaria Pf/Pan Ag test kit is an in-vitro diagnostic immunochromatographic assay for the qualitative detection of infection by Plasmodium falciparum (through P. falciparum-specific HRP2 antigens) and P. falciparum, P. vivax, P. malariae, P. ovale (through pan-pLDH antigens) in human capillary and/or venous whole blood specimens. It does not assess parasite densities. The assay is intended for trained users (in either laboratory or point-of-care settings).

Technical specifications:
Sample type: Whole blood
Sample volume: 5µl
Pf panel detection score: 83.0% at 200 parasites/μl
Pv panel detection score: 100.0% at 200 parasites/μl
False positive rate: 1.4% for clean negatives
False positive rate: 1.3% for Pf at 200 parasites/μl
False positive rate: 0.0% for Pv at 200 parasites/μl
Invalid rate: 0.1%
Reading time: 20-30 mins

Manufacturer product reference:
Meril Diagnostics Pvt. Ltd., India. MHLRPD-04

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
·2 x Assay buffer bottle (3.0ml)
·25 x Specimen transfer devices (5ul) (Manufacturer : AJOSHA BIO TEKNIK PVT. LTD., India)
·25 x Sterile non-safety lancets (Manufacturer : Medtrue Enterprise Co., Ltd., China - CE Marked)
·25 x Alcohol swabs (Manufacturer : Phoenix Innovative Healthcare Manufacturers Pvt. Ltd., India)
·1 x IFU

Items required, but not supplied:
Disposable gloves, timer, container for biohazard disposables, sharp box, pencil or pen, venipuncture blood collection materials and precision pipette plus tips

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

Weight and volume:
Estimated weight: 0.25kg
Estimated volume: 0.0013m3

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 One Step MERISCREEN Malaria Pf/Pan Ag, kit of 25 tests
Secondary packaging: One kit One Step MERISCREEN Malaria Pf/Pan Ag, 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).