SARS-CoV-2 IgG/IgM Detection Kit (Colloidal Gold)

In March 2020, the Food and Drug Administration (FDA) established the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.  This policy went into immediate effect.  For more information regarding the emergency use authorization to fight COVID-19, please visit the FDA’s guidance page.

Application of intent to market and distribute test kits was submitted to the FDA.  We filed an Emergency Use Authorization request for the Rapid Dual IgG/IgM test of SARS-CoV-2.

Test Principle

The rapid point of care IgM/IgG antibody test is based on the principle of capture immunoassay for determination of SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum and plasma.

Packing Specification

20 Test Kits/Box

Main Components:

  • Detection card
  • Disposable plastic burette
  • Specimen Diluents (3ml/bottle)
  • Instruction (User manual)
  • Immunochromatography

Our test kit

Avidium Labs is in partnership with international laboratories and manufacturers to develop a Rapid Dual IgG/IgM test for SARS-CoV-2 virus.  It is a rapid point of care test aiding in the diagnosis of the novel coronavirus.  It requires one drop of whole blood/plasma/serum and two drops of buffer, with results available in 10 minutes.

Our Rapid Dual IgG/IgM test for SARS-CoV-2 is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma or whole blood specimens from patients suspected of the COVID-19 infection, administered by a healthcare provider.

The Rapid Dual IgG/IgM test for SARS-CoV-2 is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.  Results from the Rapid Dual IgG/IgM test for SARS-CoV-2 should not be used as the sole basis for diagnosis.

The Rapid Dual IgG/IgM test for SARS-CoV-2 is designed to detect SARS-CoV-2 antibodies. IgM antibodies are generally detectable in blood several days after the initial infection.   IgG antibodies are generally detectable later following infection. IgM antibodies may not be detected in the first few days of infection.  The sensitivity of the Rapid Dual IgG/IgM test for SARS-CoV-2 early after infection is unknown.  At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.

Positive results for both IgG and IgM may occur after infection and can be indicative of acute or recent infection.  Negative results do not preclude SARS-CoV-2 infection and the Rapid Dual IgG/IgM test for SARS-CoV-2 should not be used as the sole basis for patient management decisions.

False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

The Rapid Dual IgG/IgM test for SARS-CoV-2 is for in vitro diagnostic use only.

The Rapid Dual IgG/IgM test for SARS-CoV-2 is for use by professional healthcare providers or laboratory personnel only.

Our international partner conducted a comparative evaluation of our SARS-CoV-2 IgG/IgM detection test kit against other commercially available SARS-CoV-2 IgG/IgM detection test kits.  Result shows a positive coincidence rate of 97.92% and a negative coincidence rate of 100%.

Disclaimers:

  • 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.
  • Not for the screening of donated blood.