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

General Description:
STANDARD Q Malaria P.f/ Pan Ag Test is a rapid and membrane based immunochromatography for the qualitative detection of Plasmodium falciparum specific (Histidine Rich Protein - HRP-2) and Plasmodium species (P.falcipurum, P.vivax, P.ovale, and P.malaria) specific (plasmodium lactate dehydrogenase – pLDH) in human capillary and venous whole blood specimens of patients suspected of having malaria. The test is intended to be used by trained healthcare or laboratory professionals or other healthcare workers who have received appropriate training and trained lay providers in point of care. This product is not intended for self-testing.

Technical specifications:
Technology: Rapid and membrane based immunochromatography.
Format: Test cassette.
Sample type: capillary and venous whole blood.
Sample volume: Blood Specimen 5µl.
Sensitivity: Venous blood Malaria P.f on P.f line: 99.59% / Malaria P.v, P.o, P.m on Pan line: 100%.
Capillary blood Malaria P.f on P.f line: 99.68% / Malaria P.v, P.o, P.m on Pan line: 100%.
Specificity: Venous blood 100%
Capillary blood 100%
Time to result: Minimum of 15 minutes.

Manufacturer product reference: SD Biosensor, 09MAL30D.

Kit content:
·1x25The test device (individually in a foil pouch with desiccant).
·1x1 Buffer Bottle, 4 ml.
·1x25 Inverted cup (5μl)
·1x25 sterile lancet.
·1x 25 Alcohol swab.
·1x1 IFU.

Items required, but not supplied:
General Lab equipment’s:
·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.

Storage and transportation:
Store the kit unopened at 2 to 40°C out of the direct sunlight for the duration of its shelf life.
Packaging and labeling:
Primary packaging: All contents of STANDARD Q Malaria P.f/ Pan Ag Kit/25 Test
Secondary packaging: One kit STANDARD Q Malaria P.f/ Pan Kit/25T.

Weight and volume:
Estimated weight: 0.25 Kg.
Estimated volume: 1.45 dm3.

General recommendations:
1.Carefully read the instruction for using the STANDARD Q Malaria P.f/Pan AgTest.
2.Check the expiry date at the back of the foil pouch. Use another lot, if expiry date has passed.
Open the foil pouch and check the test device and the colour indicator desiccant pack in foil pouch

Useful links:
WHO list of prequalified in vitro diagnostic products: