The Cure IV COVID – 19 Update : Learn More & FAQ's
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COVID-19 IgG/IgM ANTIBODIES RAPID TEST

 

 

 

The COVID-19 IgG & IgM  Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19 for recent or past infection. 

  

How accurate is COVID-19 IgG/IgM Rapid Test Device?

 

  • The COVID-19 IgG/IgM has been evaluated with the 113 blood samples obtained from patients exhibiting pneumonia or respiratory symptoms.
  • The sensitivity of the IgM test is 87.9% and specificity 100% when compared to RT-PCR.
  • The sensitivity of the IgG test is 97.2% during the convalescence period, and specificity is 100%.

 

What is the significance of the various test results?

 

  • IgM negative, IgG negative: Patient not exposed or too early.
  • A medical professional should observe symptoms and epidemiology of patients.
  • Retesting should be considered if symptoms appear or persist. 
  • IgM positive, IgG positive/negative: Acute or recent infection.
  • IgM negative, IgG positive: Previous, distant infection.

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FDA Required Notice: 

 
  • This test has not been reviewed by the FDA. For use in clinical laboratories by health care professionals following FDA guidance “Policy for Diagnostic Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency”.
  • 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 assay 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.
  • Not for the screening of donated blood
  • To review a complete copy of the FDA’s Guidance please click here: https://www.fda.gov/media/135659/download

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