| Storage |
2~30 º C |
| Specimen |
Whole Blood |
| Component |
Rapid Test + Buffer + Pipettes |
| Principle |
Colloidal gold rapid tests |
| Reading |
Within 15mins |
| Package |
40tests/Box |
| Trademark |
Dewei |
| Origin |
China |
INTENDED USE
The Malaria plasmodium falciparum (P.f.) Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum in whole blood.
For professional use only.
For in vitro diagnostic use only.
PRINCIPLE
The Malaria P.f. Rapid Test is a qualitative, membrane based immunoassay for the detection of P.f. antigen in whole blood. The membrane is pre-coated with P.f. antibody. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with P.f. antibody on the membrane on the test line. If the specimen contains P.f. antigen, a colored line will appear in the test region. The absence of the colored line in test region indicates that the specimen does not contain P.f. antigen. To serve as a procedure control, a colored line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.
STORAGE
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.
OPERATION
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
INTERPRETATION OF RESULTS
Positive (+)
Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
Negative (-)
Only one colored band appears, in the control region (C). No colored band appears in the test region (T).
Invalid
Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
PRODUCT IMAGES
R&D TEAM
PRODUCTION LINE
CERTIFICATES
EXHIBITIONS
SHIPMENTS
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