ONE STEP Malaria (Pf) Test, kit/25

General description:
ONE STEP Malaria (Pf) Test is a colloidal gold, two site sandwich immunoassay utilizing whole blood (venous and fingerstick) for the detection of Pf specific histidine rich protein-II (Pf HRP-II). This rapid test can be used as an aid in the diagnosis of malarial infection caused by P. falciparum for symptomatic patients, including adults (including pregnant women) and children. This test is intended for professional use by laboratory professionals, trained healthcare workers or trained lay providers in laboratory and non-laboratory settings.

Technical specifications:
Sample type: Capillary or venous whole blood
Sample volume: 5µl
Pf panel detection score: 89.0% at 200 parasites/μl
False positive rate: 0.0% for Pv at 200 parasites/μl
Invalid rate: 0.0%
Reading time: 15-20 mins

Manufacturer product reference:
InTec Products, Inc., China. ITPW11007-TC25
QMS/Regulatory information:
·ROW
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·25 x Test cassettes
·3 x Buffer bottles (2.0ml)
·25 x Droppers (Manufacturer: Cangzhou Huaao Plastic Products Co., Ltd., China)
·25 x Sterile non-safety lancets (Manufacturer: Shandong Lianfa Medical Plastic Products Co. Ltd., China – CE Marked)
·25 x Alcohol swabs (Manufacturer: SteriLance Medical (Suzhou) Inc., China – CE Marked)
·1 x IFU

Items required, but not supplied:
Timer or stopwatch; blood sampling tools (sterile gauze pad, venous puncture device, collection tube, with EDTA/heparin sodium/sodium citrate for whole blood or plasma, collection tube with no anticoagulant for serum.); biohazard waste bin and sharps bin; disposable gloves; a calibrated precision pipette and applicable pipette tips

Shelf life:
24 months from the date of manufacturing; do not use beyond its expiry date.

Weight and Volume:
Estimated weight: 0.333kg
Estimated volume: 1.70dm3

Storage & transportation condition:
The test kit should be stored at 2°C to 40°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of ONE STEP Malaria (Pf) Test, kit for 25 tests
Secondary packaging: One kit ONE STEP Malaria (Pf) Test, 25 tests

General recommendations:
For 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).