Malaria PF Rapid Test Colloidal Gold
Production information| Model Number | Malaria PF | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Malaria PF Rapid Test Colloidal Gold | Instrument classification | Class I |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Summary Malaria is caused by single-celled microorganisms of the plasmodium group, it’s normally spread by bites of mosquitos, and it’s an infectious disease that affects lives and life safety of human beings and other animals. Patients infected with malaria normally will have fever, fatigue, vomiting, headache and other symptoms, and severe cases may lead to xanthoderma, seizure, coma and even death. Malaria (P.F) Rapid Test can rapidly detect antigen to plasmodium falciparum histidine-rich proteins II that exits in whole blood, which can be used for auxiliary diagnosis of plasmodium falciparum (pf) infection.Intend Use This kit is applicable to in vitro qualitative detection of antigen to plasmodium falciparum histidine-rich proteins II (HRP II), and it’s used for auxiliary diagnosis of plasmodium falciparum (pf) infection. This kit only provides histidine-rich proteins II (HRP II) antigen detection result, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
The WIZ BIOTECH reagent test will be compared with the control reagent: | Reference | Sensitivity | Specificity |
| Well-know reagent | P.F.98.54%,Pan:99.2% | 99.12% |
Test procedure | 1 | Restore sample and kit to room temperature, take test device out of the sealed pouch, and lie it on horizontal bench. |
| 2 | Pipette 1 drop (around 5μL) of whole blood sample into the well of test device (‘S’ well) vertically and slowly by the disposable pipette provided. |
| 3 | Turn sample diluent upside down, discard first two drops of sample diluent, add 3-4 drops of bubble-free sample diluent dropwise to the well of test device (‘D’ well) vertically and slowly, and start counting time |
| 4 | Result shall be interpreted within 15~ 20 minutes, and detection result is invalid after 20 minutes. |
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