Wondfo One Step Malaria HRP2 (P.f) Test strip

Wondfo is a globally recognized fast growing POCT company devoted to R&D, manufacture and sales of rapid diagnostic reagents and medical devices in IVD field. Apart from the Guangzhou headquarters, Wondfo also owns one overseas lab in San Diego, one branch in Chicago and several overseas offices.“Quality is life!” is paramount in everything we do. Wondfo has won good reputation worldwide by providing premium products and professional services. We aim at serving the public, and hence people will trust Wondfo.

1. Quick and easy operation and 99% accuracy.

2. Wondfo has 27 years history, and has won good reputation around the world for good quality products and professional services..

3. Wondfo have got CE certificates, FSC certificates, ISO 9001:2008 and ISO 13485:2012 quality system certification.

4. For in vitro diagnostic use only. For self-testing use only.

Wondfo One Step Malaria HRP2 (P.f) Test strip is designed as a rapid self-performing, qualitative, two site sandwich immunoassay for the detection of P. falciparum specific histidine rich protein – 2 (P.f HRP-2) in whole blood samples. It is a sensitive and specific test for the detection of P.falciparum malaria. The assay is intended for use with whole blood and does not require additional instruments.
For in vitro diagnostic use only. For professional use only.

CONTENT OF THE KIT
1. 100 Individual pouches, each containing:
Test strip
Desiccant pouch
5μl sample dropper
2. Alcohol pads (optional)
3. Sterile lancets (optional)
4. 8 dropper bottles of clearing buffer (5ml/bottle)
5. Leaflet with instructions for use.

TEST PROCEDURE
Allow the device, buffer and specimen to equilibrate to room temperature (10°C ~30°C) prior to testing.
1. Remove the test strip from the foil pouch by tearing at the notch and place it on a level surface.
2. Slowly add 5 μl of whole blood to the sample pad behind the arrow mark at the bottom of test strip, and then add 4 drops (90~100ul) of clearing buffer to the sample pad.
3. As the test begins to work, you will see purple color move across the result window in the center of the test device.
4. Wait for 15 minutes and read results. Do not read results after 30 minutes.

PRECAUTIONS
1. This kit is for in vitro use only. Do not swallow.
2. Discard after first use. The test cannot be used more than once.
3. Do not use test kit beyond the expiration date.

4. Do not use the kit if the pouch is punctured or not well sealed.
5. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.
6. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards. Avoid splashing or aerosol formation. Clean up spills thoroughly using an appropriate disinfectant.
7. Keep out of the reach of children.
8. DISPOSAL OF THE DIAGNOSTIC: The used-device has the infectious risk. The process of disposing the diagnostic must follow the local infectious disposal law or laboratory regulation.