COVICHECK™ COVID-19 IgM/IgG ANTIBODY TEST

FREQUENTLY ASKED QUESTIONS

1. What is the COVICHECK™ COVID-19 IgM/IgG Antibody Test?

COVICHECK™ COVID-19 IgM/IgG Antibody Test is a lateral flow immunoassay used to qualitatively detect both IgG and IgM antibodies to SARS-COV-2 virus in human whole blood, serum or plasma.

2. How quickly can the COVICHECK™ COVID-19 IgM/IgG Antibody Test yield results?

Results can be interpreted at 10~15 minutes after sample and buffer are added to the test cassette.

3. Is the COVICHECK™ COVID-19 IgM/IgG Antibody Test available for sale in the United States?

Due to the Coronavirus Public Health Emergency, the FDA updated its Policy for Diagnostic Tests for COVID-19 on March 16, 2020. Included in this update is guidance for commercial manufacturers for screening tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. On May 4, 2020 it further refined its guidance to read as follows: “Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. This policy does not apply to at-home testing, including at-home specimen collection, due to additional considerations that require FDA review.” While this application is under review, please note the following information:

• COVICHECK™ COVID-19 IgM/IgG Antibody Test has not been reviewed by the FDA.
• 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.
• Negative results do not rule out SARS-CoV-2 infection, especially in those who have been exposed to the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in those individuals.
• The results from rapid antibody testing should not be used as the sole basis to diagnose or exclude a COVID-19 infection or to determine an individual’s infection status.

4. Is the COVICHECK™ COVID-19 IgM/IgG Antibody Test CLIA-Waived?

At present our test is neither FDA EUA nor CLIA-Waived. The current FDA Policy for Diagnostic Tests for Coronavirus Disease 2019 does not provide a CLIA categorization and does not override any CLIA requirements. Until such time that an EUA process provides a CLIA categorization, we cannot make any claims regarding CLIA status. This device may only be used in high complexity settings (as detailed in #3 above).

5. How does the COVICHECK™ COVID-19 IgM/IgG Antibody Test work?

The test strip uses a hybrid formula of colloidal gold bound recombinant viral antigens and a quality control antibody colloidal gold marker. The strip has the follow detection lines:

• IgM – is fixed with monoclonal anti-human IgM antibody for detecting COVID-19 IgM antibodies.
• IgG – is fixed with monoclonal anti-human IgG antibody for detecting COVID-19 IgG antibodies.
• C- The quality control antibody is fixed on the C (Control) line.

6. How accurate is the COVICHECK™ COVID-19 IgM/IgG Antibody Test Device?

In validation studies the IgM & IgG combined clinical sensitivity was observed to be 100% and the clinical specificity was 97.8% when compared to RT-PCR.

7. What if someone tests positive using this test device?

Please refer to the CDC Interim Guidelines for COVID-19 Antibody Testing for additional information regarding the application of this device.

8. Who can buy and use the COVICHECK™ COVID-19 IgM/IgG Antibody Test?

Professional Health Care institutions and Medical Distribution Companies are the only authorized purchasers of this product. The Covid-19 IgM/IgG Rapid Test is NOT for home use. Use of this test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing.

9. What are the benefits of using this type of Rapid Test?

• Prevalence Screening – The COVICHECK™ COVID-19 IgM/IgG Antibody Test can provide presumptive qualitative results onsite in a matter of minutes. Providing healthcare workers and officials with more information regarding the transmission of SARS-CoV-2 within a community.
• Diagnosis Support – Serologic testing can be offered as a method to support diagnosis of COVID-19 illness for persons who present late. For persons who present 9–14 days after illness onset, serologic testing can be offered in addition to EUA viral direct detection tests such as RT=PCR or viral antigen tests. During this time period, the sensitivity of nucleic acid detection may significantly decrease, and the sensitivity of serologic testing may provide an accurate indication of infection.
• Prior Illness Identification – Individuals without access to nucleic acid testing while symptomatic may elect to take a serology test once recovered for further information regarding a recent illness.
• Possible Protection – The presence of anti-SARS-CoV-2 antibodies indicates a previous infection and possibly at least some degree of immunity or protection against future SARS-CoV-2 infection. However, until the durability and duration of immunity are established, it cannot be assumed that individuals who test positive for SARS-CoV-2 antibodies, including IgM or IgG, are protected from future infection.
• Recovery Confirmation – Recovered individuals may use the COVICHECK™ COVID-19 IgM/IgG Antibody Test in conjunction with approved nucleic acid or antigen tests to confirm recovery and the existence of IgM and/or IgG antibodies in the blood stream.

IMPORTANT NOTIFICATION

According to Section D in the FDA Guidance document entitled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”, revised 5-4-2020, please note the following requirements:

“The policy described in this subsection applies to developers of serology tests that identify antibodies (e.g., IgG, IgM) to SARS-CoV-2 from clinical specimens. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. This policy does not apply to at-home testing, including at-home specimen collection, due to additional considerations that require FDA review.” The entire guidance can be viewed in their “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” document.

Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports: ·

• 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.

SUPPORT DOCUMENTS

• INDUSTRY GUIDANCE AND IMPORTANT INFORMATION
  1. CDC Interim Guidelines for COVID-19 Antibody Testing
  2. Mass General and Brigham Center for COVID Innovation
  3. American Medical Association. Serological Testing for SARS-CoV-2 Antibodies
  4. Johns Hopkins Center for Health Security COVID-19 Resources and Updates