Intended Use
The Malaria Pf/Pv Antigen Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) and vivax (Pv) antigen in human blood specimen. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with plasmodium. Any reactive specimen with the Malaria Pf/Pv Antigen Assay Kit (Colloidal Gold) must be confirmed with alternative testing method(s) and clinical findings.
Product Description
One step rapid diagnostic whole blood malaria P.f./P.v./ P.f./Pan.rapid diagnostic test kit
Specification |
20tests/kit |
Test Method |
Colloidal Gold |
Power source |
Manual |
Shelf life |
See manufacture date on label |
Qualification |
EU CE, ISO13485:2016 |
Function |
For medical use |
Service |
OEM service are avaliable |
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Test Procedure
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen.Mix the specimen well prior to assay once thawed. Blood will be hemolyzed after thawing.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: Fill the blood transfer device (sample loop, mini plastic dropper or capillary tube) with the blood specimen not to exceed the specimen line as shown in the following images. The volume of the specimen is around 5 µL.
Note: Practice a few times prior to testing if you are not familiar with the blood transfer device. For better precision, transfer specimen by pipette capable of delivering a 5µL volume.
Holding the blood transfer device (sample loop, mini plastic dropper or capillary tube) vertically, dispense the entire specimen into the center of the sample well making sure that there are no air bubbles.
Then add 2 drops (about 50-100 µL) of Lysis Buffer immediately.
Step 5: Set up timer.
Step 6: Results can be read in 30 minutes. It may take more than 20 minutes to have the background become clearer.
Don’t read results after 30 minutes. To avoid confusion, discard the test device after interpreting the result.
FAQ
1.Delivery date
A:leading time of sample order is about 3-5 wordays.
2.Shipment
A:We usually ship by DHL, UPS, FedEx. It usually takes 3-5 days to arrive.Airline and sea shipping is also optional.
3.If you accept OEM?
A:yes,OEM is avaliable
4.Will you help me register the products in my country?
A:we would like offer technical documents and support to help you to register the products until the registration is finished.
5.Do you have MOQ?
Low MOQ, 1pc for sample checking is available
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