STANDARD Q Malaria Pf/Pv Ag Test,kit/25

General description:
STANDARD Q Malaria P.f/P.v Ag Test is a rapid and membrane based immunochromatography for the qualitative detection of Plasmodium falciparum (P. falciparum) specific Histidine Rich Protein 2 (HRP-2) and Plasmodium vivax specific Plasmodium lactate dehydrogenase (pLDH) in human capillary and venous whole blood specimens of patients suspected of having malaria. STANDARD Q Malaria P.f/P.v Ag Test is intended to be used by trained healthcare or laboratory professionals or other healthcare workers who have received appropriate training. This product can be used by trained lay providers operating in point of-care settings in resource-limited lower- and middle-income countries. This product is not intended for self-testing.

Technical specifications:
Sample type: capillary and venous whole blood
Sample volume: 5µl
Pf panel detection score: 85.0%
Pv panel detection score: 100.0%
Pf false positive rate: 0.5%
Pv false positive rate: 0.0%
Invalid rate: 0.0%
Reading time: 15-30 mins

Manufacturer product reference:
SD Biosensor, Inc. 09MAL20D

QMS/Regulatory information:
·CE Marked
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·25 x Test device pouch containing: 1 test device and 1 desiccant.
·1 x Buffer bottle (4.0ml)
·25 x Inverted cup (5ul) (Manufacturer: HLB Life science CO., LTD, Korea)
·25 x Sterile non-safety lancets (Manufacturer: Beijing Ruicheng Medical Supplies Co., Ltd., China – CE Marked)
·25 x Alcohol swabs (Manufacturer: HLB Co., LTD. Healthcare. Korea – CE Marked)
·1 x IFU

Items required, but not supplied:
Anti-coagulant tube containing heparin, EDTA or sodium citrate for collection of venous whole blood, Micropipette and tip, Timer, PPE (Personal Protective Equipment), Pen/pencil, Extra lancets and alcohol swabs, Biosafety sharps container, Biohazard container, Sterile gauze.

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

Weight and volume:
Estimated weight: 0.23kg
Estimated volume: 0.002m3

Storage & transportation condition:
The test kit should be stored at 2 to 40°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of STANDARD Q Malaria P.f/Pv Ag, kit for 25 tests
Secondary packaging: One kit STANDARD Q Malaria P.f/Pv 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).