NxTekEliminateMalPfSafetyLanc,kit/25

General description:
The NxTek Eliminate Malaria Pf is an ultra-sensitive, qualitative in vitro test for the detection of histidine rich protein 2 (HRP2) antigen of Plasmodium falciparum malaria in human whole blood. The test is intended for professional use and the point-of-care testing to aid in the diagnosis of malaria infection to a general population including pregnant women.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 25 tests
Sample type: Whole blood
Sample volume: 5µl
Pf panel detection score: 98.0%
False positive rate: 0.9%
Invalidity rate: 0.1%
Reading time: 20 mins

Manufacturer product reference: Abbott Diagnostics Korea Inc., 05FK141

Items supplied with:
·Test device with a desiccant in individual foil pouch, 25
·Assay diluent vial (5ml), 1
·Disposable inverted cup, 25
·Alcohol swab, 25
·Safety lancet, 25
·Instruction for use, 1

Items required, but not supplied:
Disposable gloves, timer, container for biohazard disposables, pen/pencil, sterile gauze, if collection by venipuncture: Venipuncture blood collection tube, micropipette, pipette tips

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

Weight and Volume:
Estimated weight: 0.28 kg
Estimated volume: 1.311 dm3

Storage and transportation condition:
Between 1 to 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of NxTek Eliminate Malaria Pf with safety lancet, kit for 25 tests
Secondary packaging: One kit NxTek Eliminate Malaria Pf with safety lancet, 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).