FirstResponse MalAgpLDH/HRP2Combo,kit/25

General description:
First Response Malaria Ag pLDH/HRP2 Combo Card Test is an in vitro rapid qualitative immuno-chromatographic test for detection of all four Plasmodium Species (P. falciparum, P. vivax, P. ovale and P. malariae) 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: 82.0%
Pv panel detection score: 91.4%
False positive rate: 1.9% for clean negatives
1.5% for Pf
0.0% for Pv
Invalid rate: 0.1%
Reading time: 20-30 mins

Manufacturer product reference:
Premier Medical Corporation, India. PI16FRC25

QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·25 x Test device pouch containing: 1 test device and 1 dessiccant
·1 x Assay buffer bottle
·25 x Specimen transfer devices (Manufacturer: Precision Medical Device Industries, India)
·25 x Alcohol swabs (Manufacturer : Medtrue Enterprise Co., Ltd. China - CE Marked)
·25 x Sterile non-safety lancets (Manufacturer : Shandong Lianfa Medical Plastics Products Co Ltd, China - CE Marked)
·1 x IFU

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 & transportation condition:
The test kit should be stored at 1 to 40°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of First Response Malaria Ag pLDH/HRP2 Combo Card Test, kit for 25 tests
Secondary packaging: One kit First Response Malaria Ag pLDH/HRP2 Combo Card Test, 25 tests

General recommendations:
For guidance on selection criteria for procurement of mRDTs,
Public < a href="https://extranet.who.int/pqweb/vitro-diagnostics/prequa lification-reports/whopr">>reports of WHO prequalified in vitro diagnostic products
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).