SD Bioline Malaria Pf/Pv, kit/25

General Description:
SD Bioline Malaria Ag Pf/Pv, is a qualitative immuno-chromatographic test to diagnose the presence of HRP2 (Pf) and pLDH (Pv).

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: 92.0%
Panel detection score at low P.v. parasitemia: 94.3%
False positive rate for P.spp.: 1.9
Invalidity rate: 0.0
Reading time: 15 mins
Manufacturer product reference:
Standard Diagnostics,
05FK80.

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/Pv, kit for 25 tests Secondary packaging: One kit
SD Bioline Malaria Ag Pf/Pv, 25 tests

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

General recommendations:
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).