CE Malaria P.f P.v Whole Blood Test Kit Diagnostic Cassette High Sensitivity
【INTENDED USE】
The Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of two kinds of circulating plasmodium falciparum (P. falciparum (P.f.) and P. vivax (P.v.) in whole blood.
【SUMMARY】
The Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) is a rapid test to qualitatively detect the presence of P. falciparum - specific HRP-II and P. vivax (P.v.). The test utilizes colloid gold conjugate to selectively detect P.fspecific and P. vivax (P.v.)-specific antigensin whole blood.
【OPERATION】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface.
For Whole Blood specimen:
• Use a pipette: To transfer 5uL of whole blood to the specimen well, then add 3 drops of buffer (approximately 120uL).
• Use a disposal specimen dropper: Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximately 5uL). Transfer the specimen to the specimen well, then add 3 drops of buffer (approximately 120uL), and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE:* Two or Three distinct colored lines appear.
P. falciparum or mixed malaria infection:one line appears in the control region, one line appears in P.v. line region and one line appears in P.f. line region.
P. falciparum infection: one line appears in the control region, and one line appears in P.f .line region.
Non-falciparum Plasmodium species infection:one line appears in the control region and one line appears in P.v. line region.
*NOTE: The color intensity of P.f. or P.v. test lines may vary depending on the concentration of antigens, viz., HRP-II or P. vivaxLDH present in the specimen.
NEGATIVE: Only one colored line appears in the control region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
【CONTENTS】
Test Cassettes
Disposable specimen droppers
Buffer
Package insert
【STORAGE AND STABILITY】
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch
The test must remain in the sealed pouch until use
Keep away from direct sunlight, moisture and heat
Do not freeze.
Care should be taken to protect the components of the kit from contamination.
Do not use if there is evidence of microbial contamination or precipitation.
Biological contamination of dispensing equipment, containers or reagents can lead to false results.
【Manufacturer】
DEWEI MEDICAL EQUIPMENT CO.,LTD
5th floor, No. 4 building, Shiyou Industrial Park, Jun'an , Shunde, Foshan, China 528329
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CE Malaria P.F P.V Whole Blood Test Kit High Sensitivity Diagnostic Test Cassette Images
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