SDMal Ag Pf/Pv wnonsafetylancet,10T/kit

General Description:
SD Bioline Malaria Ag Pf/Pv is a qualitative immuno-chromatographic test to diagnose the presence of HRP2 (Pf) and pLDH (Pv). The minimum order quantity is 3,000 kits.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Format: Cassette, 10 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,
05FK86.

Items supplied with:
1.Test cassettes individually packed in foil pouch with a desiccant, 10
2.Assay diluent bottle (3ml), 1
3.Specimen transfer devices (5μl), 10
4.Alcohol swabs, 10
5.Non-safety lancets, 10
6.Instructions for use, 1

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.

Weight and Volume:
Estimated Weight: 0.156 kg
Estimated Volume: 0.00094 m3

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 10 tests
Secondary packaging: One kit SD Bioline Malaria Ag Pf/Pv, 10 tests

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).