Malaria PF PV rapid test uncut sheet
1. INTEDED USE
The Malaria Pf/PAN Antigen Rapid Test Device (the “uncut sheet” format for manufacturing use) is intended for the qualitative and differential detection antigen to plasmodium falciparum histidine-rich proteins II (HRPII) and antigen to plasmodium vivax lactate dehydrogenase (pvLDH) in human whole blood specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis and differentiation of malaria infections caused by P. falciparum and other Plasmodium species (P. vivax, P. ovale, and P. malariae) in patients presenting with clinical signs and symptoms.
The device provides presumptive (preliminary) screening test results. Negative results do not rule out malaria infection, particularly at low parasite densities (below the detection limit of approximately 200 parasites/µL) . Positive results are preliminary and should be confirmed by alternative diagnostic methods such as microscopy (the gold standard) or molecular assays (e.g., PCR) in accordance with current clinical guidelines . Results should be interpreted in conjunction with patient history, clinical presentation, and epidemiological exposure.
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | Malaria PF PV 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 |
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Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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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.
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| 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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4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
6.EXHIBITION
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
