Intended Use
The test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Hepatitis A virus (HAV) and Hepatitis E virus (HEV) in serum, plasma or whole blood samples.
Product Description
Hepatitis A & HEV combo IVD rapid test kit test strips with CE approved.
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 |

Test Procedure
Please read this instruction carefully before use.
1.Place the test card on a clean and level surface.Sample to be tested at room temperature.
2.For Serum or Plasma Specimens:
Transfer 10μL serum/plasma to the sample well of the card, then add 60μL(approximately 2 drops)of buffer, and start the timer.
For Whole Blood Specimens:
Transfer 20μL whole blood to the sample well of the card, then add 60μL(approximately 2 drops)of buffer, and start the timer.
Note: If the pouch is opened beyond an hour before use, the sensitivity of the test will be impacted.
Specimens can also be applied using a micropipette.
3. The result should be read in 15 minutes.
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
bio-equip.cn