One Step MERISCREEN Mal Pf/Pv Ag, kit/30

General description:
One Step test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag test kit is an in vitro diagnostic immunochromatographic assay for the qualitative detection of infections with Pf and Pv parasites and to differentiate infection between Pf-HRP2 and Pv-pLDH in human whole blood specimens.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 30 tests
Sample type: Whole blood
Sample volume: 5µl
Pf panel detection score: 78.0%
Pv panel detection score: 85.7%
False positive rate: 0.0% for clean negatives
0.5% for Pf
0.7% for Pv
Invalid rate: 0.0%
Reading time: 20 mins. Don’t read test results after 30 minutes. Reading too late can give false results.

Manufacturer product reference: Meril Diagnostics Pvt. Ltd., MFLRPD-02

Items supplied with:
1.Cassette packaging, each containing 1 device and a desiccant, 30
2.Assay buffer bottles (3.0ml), 2
3.Specimen transfer device (5µl), 30
4.Alcohol swab, 30
5.Lancet, 30
6.Instruction for use, 1

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: 0.32 Kg
Estimated volume: 0.0016 m³

Storage and transportation condition:
Between 1 - 40°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of One Step MERISCREEN Mal Pf/Pv Ag, kit of 30 tests
Secondary packaging: One kit One Step MERISCREEN Mal Pf/Pv Ag, 30 tests

General recommendations:
·For guidance on selection criteria for procurement of mRDTs, kindly refer to https://apps.who.int/iris/bitstream/handle/10665/259 870/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/prequalification-report s/whopr
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).