The Easy Check COVID-19 IgM/IgG™ Point-of-Care (POC) Antibody Test delivers accurate qualitative antibody testing results in 10-minutes.
The Easy Check COVID-19 IgM/IgG POC Antibody Test is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and/or Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human fingerstick whole blood specimen. Easy Check COVID-19 IgM/IgG POC Antibody Test is 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 how long antibodies may persist following the infection and if the presence of antibodies confers protective immunity. Easy Check COVID-19 IgM/IgG POC Antibody Test device should not be used to diagnose SARS-CoV-2 infection. This testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. This test is being distributed under Section IV.D of the FDA’s Policy for Coronavirus Disease-2019 tests during the Public Health Emergency (Revised).
The Easy Check COVID-19 IgM/IgG POC antibody test provides significant benefits over traditional lab-based diagnostic technologies.
The Easy Check COVID-19 IgM/IgG™ Point-of-Care (POC) Antibody Test is serology test designed for the qualitative detection and differentiation of Immunoglobulin M (IgM) and/or Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human fingerstick whole blood specimen. Upon receiving FDA EUA approval, our fingerstick test will eliminate the need for a blood draw and for outsourcing testing to centralized labs, reducing the sample-to-answer timeframe from days down to 10 minutes.
1Deposit 10 uL of blood sample into the handheld testing device.
2Add 1 drop of Assay Buffer.
3Read the test results at 10 minutes.
25 Test Devices
4mL Assay Buffer
25 Blood Transfer Pipettes
1 Package Insert
25 Sterile Safety Lancets
25 Alcohol Prep Pads
The Easy Check COVID-19 IgM/IgG™ POC Antibody Test has completed the Section IV.D notification process under FDA’s Policy for Coronavirus Disease-2019 Test During the Public Health Emergency (Revised). This test has not been reviewed by the FDA. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection. 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.