| Model Number | Malaria PF/PAN | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Malaria P.F / pan Rapid Test (Colloidal Gold) | Instrument classification | Class III |
| 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 a protozoan that invades human erythrocytes. Malaria is one the most prevalent diseases in the world. According to estimation of World Health Organization (WHO), there are 300~500 million cases of the disease and over 1 million deaths annually throughout the world. Timely and accurate diagnosis is the key to outbreak control as well as effective prevention and treatment of malaria. The commonly used microscopy method is known as the gold standard for diagnosis of malaria, but it highly depends on skills and experiences of technical personnel and takes relatively long time. Malaria P.F/Pan Rapid Test can rapidly detect antigen to plasmodium falciparum histidine-rich proteins II and antigen to pan-plasmodium lactate dehydrogenase that exit.Intend Use This kit is applicable to in vitro qualitative detection of antigen to plasmodium falciparum histidine-rich proteins II (HRPII) and antigen to pan-plasmodium lactate dehydrogenase (panLDH) in human whole blood sample, and it’s used for auxiliary diagnosis of plasmodium falciparum (pf) and pan-plasmodium (pan) infection. This kit only provides detection result of antigen to plasmodium falciparum histidine-rich proteins II and antigen to panplasmodium lactate dehydrogenase, 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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