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.

Background of novel coronavirus and COVID-19

 

Coronaviruses (CoV) are a large family of viruses that cause illness, ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). A novel coronavirus (nCoV, also known as SARS-CoV-2) is a new strain that has not been previously identified in humans. The disease caused by this novel coronavirus is then named Coronavirus Disease 2019(COVID-19) by WHO. 

Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.

More information can be found on WHO websiteCDC website.

References

Li, Z., Yi, Y., Luo, X., Xiong, N., Liu, Y., Li, S., Sun, R., Wang, Y., Hu, B., Chen, W. and Zhang, Y., Development and Clinical Application of A Rapid IgM‐IgG Combined Antibody Test for SARS‐CoV‐2 Infection Diagnosis. Journal of Medical Virology.

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