Bioline Mal Ag Pf NonSafetyLancet,kit/25

General description:
The Bioline Malaria Ag Pf test is a rapid, qualitative test for the detection of histidine-rich protein 2 (HRP2) antigen of Malaria Plasmodium falciparum in human whole blood. Bioline Malaria Ag Pf test is intended for professional use.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 25 tests
Sample type: Whole blood
Sample volume: 5µl
Pf panel detection score: 95.0% at 200 parasites/μl
False positive rate: 0.0% for Pv at 200 parasites/μl
Invalid rate: 0.0%
Reading time: 15-30 mins

Manufacturer product reference:
Abbott Diagnostics Korea Inc., Republic of Korea. 05FK50

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

Items supplied with:
·25 x Test cassettes, individually packed in foil pouch with a desiccant.
·1 x Assay diluent bottle 5.0ml
·25 x Specimen transfer devices disposable (5μl) (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, micropipette

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

Weight and Volume:
Estimated weight: 0.26kg
Estimated volume: 1.0138dm3

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

Packaging and labeling:
Primary packaging: All contents of Bioline Malaria Ag Pf with nonsafety lancet, kit for 25 tests
Secondary packaging: One kit Bioline Malaria Ag Pf with nonsafety 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).