Product Description
COV-ID™; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is a rapid immunoassay for the qualitative detection of antibodies (IgM and IgG) to SARS-CoV-2 virus (COVID-19) in fingerstick whole blood, venous whole blood, serum, and plasma (EDTA, citrate, heparin) samples from patients suspected of a history of COVID-19 infection.

COV-ID is intended for use by trained laboratory personnel and healthcare professionals.

  • Results in 10 minutes
  • Single combo test for IgG and IgM antibodies
  • Rapid, easy-to-use, highly accurate
  • Room temperature storage
  • 25 test kit
Background Information
Serology tests detect antibodies to COVID-19 and can help determine the patient’s current infection status. Antibody tests can also help establish which patients have had a past infection and theoretically developed immunity which could allow them safely to return to work. Mass serology testing can help to understand the wider extent of COVID-19 infections and herd immunity.

IgM antibody to SARS-CoV-2 is produced in the acute infection stage (5-10 days) so should ideally be tested any time after 15 days of disease onset. IgG antibody is produced secondary to IgM and indicates that the patient is at a later stage or past infection. The detection of IgM antibodies confirms a new infection while the detection of both IgM and IgG antibodies suggests a recent infection. If only IgG antibodies are demonstrated this would indicate a past infection.
Intended Use Statement
COV-ID™; the Diages.nostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is a lateral flow immunochromatographic assay intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests as well as point of care (POC) testing.

Results are for the rapid detection of antibodies (IgM and IgG) to SARS-CoV-2 virus (COVID-19). Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Use in conjunction with the testing strategy outlined by public health authorities in your area. Laboratories are required to report all positive results to the appropriate public health authorities.

The test is not a diagnostic test for acute COVID-19 infection. The sensitivity of Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 early after infection is unknown. The test is recommended for testing patients after the acute phase of infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection and successful immune response to a vaccine, once developed. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

  • COV-ID; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is available in specific global markets in compliance with country requirements.
  • COV-ID; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is CE marked and MHRA registered. This test has also been submitted for Health Canada Interim Order (IO) review as well as for review by ANVISA in Brazil.
  • COV-ID; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 has been U.S. Food and Drug Administration (FDA) notified and submitted for FDA Emergency Use Authorization (EUA) review. For professional use only in qualified CLIA certified high complexity settings. Please contact Lumos for specific product details that align with U.S. FDA notification procedures.

Contact us to order or learn more about the COV-ID antibody (IgG/IgM) test.