S0003856

AdvDx Malaria Pf, kit/25


AdvDx Malaria Pf Rapid Malaria Ag Detection Test, kit/25
Indicative Price 6.25 USD

General description:
AdvDx Malaria Pf test kit is an in-vitro diagnostic Immunochromatographic assay for the qualitative detection of malaria infection caused by Plasmodium falciparum parasites in human. It detects HRP2 antigen of Pf in whole blood specimens.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 25 tests
Sample type: Whole blood
Sample volume: 5µl
Pf panel detection score: 80.0%
False positive rate: 0.0% for clean negatives
0.0% for Pf
0.0% 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: Advy Chemical Pvt Ltd., 00-DKM-RK-MAL-ADX-004-025

Items supplied with:
1.Test device individually foil pouched with a desiccant, 25
2.Sample applicator, 25
3.Alcohol swab, 25
4.Lancet, 25
5.Buffer solution bottle, 1
6.Instruction for use, 1

Items required, but not supplied:
Disposable gloves, timer, biosafety sharps container, pencil or pen, sterile gauze or cotton, venipuncture blood collection materials and precision pipette and plus tips if whole blood collected by venipuncture

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

Weight and volume:
Estimated weight: 0.29 Kg
Estimated volume: 0.0013 m³

Storage and transportation condition:
Between 2 - 40°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of AdvDx Malaria Pf, kit of 25 tests
Secondary packaging: One kit AdvDx Malaria Pf, 25 tests

General recommendations:
·For guidance on selection criteria for procurement of mRDTs, kindly refer to https://apps.who.int/iris/bitstream/handle/10665/259870/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/prequali fication-reports/whopr
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).



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