Intended Use
The Malaria IgG/IgM Antibody Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) in human serum or plasma. This device is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with Plasmodium falciparum. Any reactive specimen with the Malaria IgG/IgM Antibody Assay Kit (Colloidal Gold) must be confirmed with alternative testing methods such as the microscopic smear test and clinical findings.
Product Description
One step IVD malaria IgG/IgM Antibody rapid diagnostic test assay kit for hospital use
Specification |
20tests/kit |
Test Method |
Colloidal Gold |
Power source |
Manual |
Shelf life |
See manufacture date on label |
Qualification |
EU CE, ISO13485:2016 |
Function |
Home test |
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 thawed specimen well prior to assaying.
Step 2: Take the desired quantity of sealed pouches from the box.
When ready to test, open the pouch at the notch and remove the test strip.
Step 3: Place the strip on a clean, flat surface.
Step 4: Fill the plastic dropper with the specimen.
Holding the dropper vertically, dispense 1 drop (about 30-45µL) of specimen onto the sample pad making sure that there are no air bubbles. Do not apply specimen beyond the line indicated by the arrows.
Immediately add 1 drop (about 35-50µL) of Sample Diluent.
Step 5: Set up the timer.
Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.
Don’t read result after 15 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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