BiolineMalAgPf/PanNonSafetyLancet,kit/25

General description:
Bioline Malaria Ag P.f/Pan test kit intended for the detection of Malaria infection in human blood specimen, indicating qualitative and differential diagnosis between HRP2(Histidine-rich protein II) specific to Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) specific to Plasmodium species (Pan) in human blood specimen. Bioline Malaria Ag P.f/Pan 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: 94.0% at 200 parasites/μl
Pv panel detection score: 91.4% at 200 parasites/μl
False positive rate: 0.0% for clean negatives
False positive rate: 0.8% for Pf at 200 parasites/μl
False positive rate: 0.7% 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. 05FK60

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: 0.27kg
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/Pan with nonsafety lancet, kit for 25 tests
Secondary packaging: One kit Bioline Malaria Ag Pf/Pan with nonsafety lancet, 25 tests

General recommendations:
For guidance on selection criteria for procurement of mRDTs, kindly refer this pagePublic reports of WHO prequalified in vitro diagnostic products
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).