NxTekEliminateMalPfNonSafetyLanc,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., Republic of Korea. 05FK140

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 Assay diluent bottle
·25 x Disposable inverted cup (Manufacturer: HLB Life science CO., LTD, Korea)
·25 x Sterile non-safety lancets (Manufacturer: Shandong Lianfa Medical Plastic Products 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:
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: 0.25kg
Estimated volume: 1.0138 dm3

Storage & transportation condition:
The test kit should be stored at 1-30°C, protected against humidity and direct sunlight. Do not freeze reagents.


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