Malaria PF 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 (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.
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 |
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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
