SDMal Ag Pf/Pv wnonsafetylancet,25T/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, 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,
05FK87.

Items supplied with:
1.25 test devices divided in three kits. 2 kits contain 8 tests and 1 kit contains 9 tests.
2.Buffer, 3 x 5ml/bottle
3.Specimen transfer devices (5μl), 30 units
4.Alcohol swabs, 30 units
5.Non-safety lancets, 30 units
6.Instructions for use, 6 copies

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

Weight and volume:
Estimated weight: 0.38 Kg
Estimated volume: 0.0023 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).