SD Bioline Malaria Pf/pan, kit/25

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.

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, 05FK60

Items supplied with:
1.Test cassettes individually packed in foil pouch with a desiccant, 25
2.Assay diluent bottle (5 ml), 1
3.Specimen transfer devices (5μl), 25
4.Alcohol swabs, 25
5.Non-safety sterile lancets, 25
6.Instructions for use, 1

Items required, but not supplied:
Disposable gloves, anti-septic swabs, absorbent paper, protective glasses, timer, 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, kit for 25 tests
Secondary packaging: One kit SD Bioline Malaria Ag Pf/Pan, 25 tests

Weight and volume:
Estimated weight: 0.31 Kg
Estimated volume: 0.0013 m³

General recommendations:
·For guidance on selection criteria for procurement of mRDTs, kindly refer to https://apps.who.int/iris/bitstream/handle/10665/259870/WHO-CDS -GMP-2018.01-eng.pdf?sequence=1
·Public reports of WHO prequalified in vitro diagnostic products can be found here: https://www.who.int/diagnostics_laboratory/evaluations/pq-li st/malaria/public_report/en/
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).