Novel coronavirus antibody, COVID-19 IgM/IgG Test Kit

Basic information on COVID-19 IgM IgG Test Kit

This novel coronavirus disease COVID-19 IgM IgG Test Kit is based on lateral flow immunoassay to detect IgM/IgG antibodies of SARS-COV-2. It can be used as an aiding tool for RT-PCR testing. Clinical diagnosis shall be done according to the doctor.

  • This product is CE marked according to EU IVD Directive 98/79/ECThis 

  • This product is registered in German DIMDI with document number 00096359.

  • This product is registered in Italian Ministry of Health with document number 1963416

  • This product has been submitted for FDA EUA review.


 

Caution:
Read carefully the kit manual before test.
This kit is for professional use only, not for home testing.
Clinical diagnosis of COVID-19 shall be done by doctor.

Component of the COVID-19 IgM IgG Test Kit

  • IgM is produced in the beginning of infection, indicates an early stage of the disease

  • IgG is produced after a period of infection, indicates the infection is ongoing or was infected.

  • Combination of IgG/IgM indicates the infection is ongoing

  • Clinical diagnosis shall be determined by RT-PCR/CT scanning.

 

How to use this COVID-19 IgM IgG Test Kit

  • Take 10-20ul blood sample (serum, full blood or plasma), add into the sample well on the test card

  • Then add 2-3 drops of sample buffer into the well.

  • Wait for 10-15min, determine the result according to the kit instruction.

Precautions on the handling of sample and lab waste

  • This kit does not contain any contagious materials, it is safe to ship/use under normal situation.

  • All samples are contagious, please handle carefully according to local regulations, or following the guidelines of your local CDC/WHO.

  • Used test cards shall be handled carefully as biolab waste, which shall be treated carefully according to guidelines of CDC/WHO.

 

Limitations of this COVID-19 IgM IgG Test Kit

  • This kit is used as aiding tool for the testing of COVID-19, which shall be used in combination with RT-PCR/CT scanning. The results shall be determined by professionals. It is not a home use test. Before licensed by CDC, this kit can only used as research tool, which can not be used in clinical diagnosis of COVID-19.

  • This test has not been reviewed by the FDA.

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

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