SDMalAgPf/panPOCT w/safelancet,1T/kitx25

General Description:
SD Bioline Malaria Ag Pf/pan is a qualitative immuno-chromatographic test to detect HRP2 (Pf) and pLDH (Pf, Pv, Po, Pm) malaria infections.
Minimum order quantity is 2,000 kits.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 25 tests
Sample type: Whole blood
Sample volume: 5µl
Panel detection score at low P.f. parasitemia: 94.0%
Panel detection score at low P.v. parasitemia: 91.4%
False positive rate for clean negatives: 0.0%
Invalidity rate: 0.0%
Reading time: 15 mins

Manufacturer product reference: Standard Diagnostics, 05FK62

Items supplied with:
1.Test devices, 25
2.Buffer, 25 x 180µl/vial
3.25 pouches, each containing 1 specimen transfer device (5μl), 1 safety lancet, 1 alcohol swab
4.Summarized instructions for use, 25 copies
5.Instructions for use, 1 copy

Items required, but not supplied:
Disposable gloves, extra anti-septic swabs, absorbent paper, protective glasses, timer, a container for biohazard disposables and disinfectant (for surfaces).

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

Storage and transportation:
Between 1 - 40°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of SD Bioline Malaria Ag Pf/Pan POCT, 25 test kits
Secondary packaging: One unit contains SD Bioline Malaria Ag Pf/Pan POCT, 25 test kits

Weight and volume:
Estimated weight: 0.61 Kg
Estimated volume: 0.0020 m³

General recommendations:
·For guidance on selection criteria for procurement of mRDTs, kindly refer to https://apps.who.int/iris/bitstream/hand le/10665/259870/WHO-CDS-GMP-2018.01-eng.pdf
·Public reports of WHO prequalified in vitro diagnostic products can be found here: https://www.who.int/diagnostics_l ab oratory/evaluations/pq-list/malaria/public_report/en/
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).