FirstResponse MalAgPf/Pv CardTest,kit/25

General description:
First Response Malaria Ag Pf/Pv Card Test is an in vitro rapid qualitative immunochromatographic test for detection of P. falciparum and P. vivax in human whole blood specimens.

Technical specifications:
Technology: Lateral immunochromatographic assay
Format: Cassette, 25 tests
Sample type: Whole blood
Sample volume: 5µl
Pf panel detection score: 94.0%
Pv panel detection score: 100.0%
False positive rate: 1.0% for clean negatives
0.8% for Pf
0.7% for Pv
Invalid rate: 0.1%
Reading time: 20 mins. Don’t read test results after 30 minutes. Reading too late can give false results.

Manufacturer product reference: Premier Medical Corporation Limited, PI19FRC25

Items supplied with:
1.Individually pouched test devices with desiccant, 25
2.Specimen transfer device, 25
3.Alcohol swab, 25
4.Sterile lancet, 25
5.Assay buffer bottle, 1
6.IFU, 1

Items required, but not supplied:
Disposable gloves, permanent marker pen, timer, extra lancets and alcohol swabs if needed, biohazardous waste container and sharp disposable box, venipuncture blood collection kit (if whole blood is collected by venipuncture)

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

Weight and volume:
Estimated weight: 0.250 kg
Estimated volume: 0.0010 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 First Response Malaria Ag Pf/Pv Card Test for 25 tests
Secondary packaging: One kit First Response Malaria Ag Pf/Pv Card Test, 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).