Malaria PF rapid test uncut sheet
1. INTEDED USE
Malaria PF Rapid Test Device (the "uncut sheet" format for manufacturing use) is a rapid immunochromatographic assay intended for the qualitative detection of histidine-rich protein 2 (HRP-2) antigen of Plasmodium falciparum in human whole blood specimens .
This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of P. falciparum malaria infection in patients presenting with clinical signs and symptoms suggestive of malaria . The test detects P. falciparum-specific HRP-2 antigens, which are produced by P. falciparum parasites.
The device provides presumptive (preliminary) screening test results. Negative results do not rule out malaria infection, particularly at low parasite densities, and should be confirmed by alternative diagnostic methods such as microscopy (the gold standard) or molecular assays (e.g., PCR) when necessary
The test result should be interpreted in conjunction with patient history, clinical presentation, and other laboratory findings. This test is not intended for self-testing . This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | Malaria PF Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | whole blood |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
|
3.TEST METHOD
| 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.
|
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
