S0003773

CareStart Malaria HRP2(Pf), kit/25


Rapid diagnostic test CareStart Malaria HRP2(Pf), kit/25
Indicative Price : 8.46 USD

General Description:
CareStart Malaria HRP2(Pf), is a rapid qualitative immuno-chromatographic test for detection pf malaria HRP2 of Pf in human whole blood.

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: 91.0%
False positive rate: 0.9%
Invalidity rate: 0.0
Reading time: 20 mins
Manufacturer product reference: Access Bio,
Old G0141/ RMOM-02571.

Items supplied with:
1.Cassette, sealed in pouch with a desiccant, 25
2.Buffer (4 ml), 1 bottle
3.Specimen transfer devices, 25
4.Alcohol swabs, 25
5.Lancets, 25
6.Instruction for use, 1

Items required, but not supplied:
Disposable gloves, timer, container for biohazard disposables, pen/pencil, sterile gauze

Shelf life:
30 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 CareStart Malaria HRP2(Pf), kit for 25 tests
Secondary packaging: One kit CareStart Malaria HRP2(Pf), 25 tests

Weight and volume:
Estimated weight: 0.202 Kg
Estimated volume: 0.74 dm³

General recommendations:
For guidance on selection criteria for procurement of mRDTs, kindly refer to
https://apps.who.in t/iris/bi tstream/handle/10665/259870/WHO-CDS-GMP-2018.01-eng.pdf?sequence=21
Public reports of WHO prequalified in vitro diagnostic products can be found here:
https://www.who.int/dia gnostics_lab oratory/evaluations/pq-list/malaria/public_report/en/
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
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