The COVID-19 Rapid Antibody Testing Kit provides qualitative overview of novel SARS-CoV-2 antibodies in suspected patients. Test enables health systems to appropriately allocate resources by triaging patients and healthcare workers into subgroups that may be discharged, quarantined, require further testing and or consideration for initiating treatment. Of course, this remains at the discretion of the provider if not confirmed with molecular based testing.
Sample size (n=1,300)
FDA Guidance Document: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Services (HHS) declaration notice that circumstances exist to justify the emergency use of in-vitro diagnostics (IVDs) for the detection of novel SARS-CoV-2, which causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19.
The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
What do I need to know about COVID-19 testing?
Current information on COVID-19 for healthcare providers is available on the CDC’s web page, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section).
Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information” section).
Use appropriate personal protective equipment (PPE) when collecting and handling specimens from individuals suspected of being infected with COVID-19 as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information” section).
What is an EUA?
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Services (HHS) declaration notice that circumstances exist to justify the emergency use of in-vitro diagnostics (IVDs) for the detection of novel SARS-CoV-2, which causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19.
The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
Are these tests EUA approved?
No. All products carried have been validated independently and have submitted applications for EUA approval. Per FDA, we are OK to commercialize and distribute these tests.
How accurate is the clinical data surrounding these tests?
The clinical data has been validated by external agencies outside of the US. Products carry the “CE” marking which is required for these types of devices to be sold in European Union (EU). “CE” marking denotes that the device has met the applicable EU regulations and enables commercialization.
Have we validated the results ourselves?
We are distributor of the test and do not collect performance data. Data validation was conducted externally by other health organizations outside of the US. The test is currently being reviewed by the FDA for EUA consideration
Are the tests legitimate? (There’s a lot of reports to not purchase tests that are not EUA approved)
All of our products sourced are accompanied with Declarations of Conformity. Prior to tests being distributed to approved end users, we conduct QA to ensure all products are sent appropriately.
Is Medicaid reimbursing for these tests?
Medicaid is a federal entity, but it is regulated by each respective state. Therefore, it is difficult to comment on reimbursement on a state-by-state basis. CPT codes are available for antibody and molecular based tests.
What is the average reimbursement?
What resources can I go to for updates and more information on COVID-19?
FDA Resources
What does it mean if the specimen tests negative for the virus that causes COVID-19?
A negative test result for this test means that novel antibodies specific to SARS-CoV-2 was not present in the specimen. A negative result may be caused by low concentrations of the IgM or IgG antibody in the sample and therefore cannot completely rule out the possibility of COVID-19. Therefore, negative results should not be used as the sole basis for treatment or patient management decisions.
When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19.
The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other
respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other
clinical findings, re-testing should be considered by healthcare providers in consultation with public health authorities.
Risks to a patient of a false negative include: delayed or lack of supportive treatment, lack of monitoring infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.
What does it mean if the specimen tests positive for the virus that causes COVID-19?
A positive test result for COVID-19 indicates that there is a presence of novel antibodies specific to SARS-CoV-2 and the patient is presumptively infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management decisions should be made with a healthcare provider and follow current CDC guidelines.
The IPS-COVID-19 IgM/IgG Antibody Rapid Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects. All laboratories or healthcare facilities using this test must follow the standard confirmatory testing and reporting guidelines according to their appropriate public health authorities.
How do I enroll in or apply to the CLIA program?
You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory is located. Additionally, check with your State Agency for any other state-specific requirements. If you do not have online access and do not have information about your State Agency, you may contact the CLIA program at 410-786-3531 for the address and phone number of your State Agency.
Submitting a form does not commit (hold) inventory. This is an inquiry to acquire COVID-19 Rapid Antibody Test.
