Malaria PF PAN rapid test uncut sheet
1. INTEDED 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 pan plasmodium 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 Malaria Pf/PAN Antigen Rapid Test Uncut sheet is a rapid Colloidal God intended for the qualitative detection of Plasmodium falciparum (Pf) and Pan-malaria species antigens in human whole blood specimen.
This test simultaneously detects:
- Plasmodium falciparum-specific Histidine-Rich Protein 2 (HRP-2) antigen
- Pan-Plasmodium lactate dehydrogenase (pLDH) antigen, which is common to P. falciparum, P. vivax, P. ovale, and P. malariae
This test is intended for in vitro diagnostic professional use and serves as an aid in the differential diagnosis of P. falciparum and non-falciparum malaria infections in patients presenting with signs and symptoms suggestive of malaria.
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 or molecular assays (e.g., PCR) when necessary. Positive results do not differentiate between current and recent infection when using HRP-2 based detection, as HRP-2 antigen may persist following resolved infection.
This product is intended for use by trained healthcare professionals or laboratory personne
2. PRODUCT SPECIFICATION
| Model No. | Malaria PF Pan 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
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
