Rapid COVID-19 Antigen Nasal Swab

CareStart™ COVID-19 Antigen test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. • The CareStart™ COVID-19 Antigen test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

This test has an emergency access mechanism called an Emergency Use Authorization (EUA).

The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of diagnostics (IVDs) for the detection and/or diagnosis of the virus that 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 diagnosing 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).

At the time of this signed form, the CPT/HCPCS code for this procedure/service is not adequately paid by commercial insurances.

I, the undersigned, understand that I am waiving all rights for NEWPORT CENTER URGENT CARE to submit this procedure/service, the CareStart™ COVID-19 Antigen test to insurance for reimbursement. I am willingly paying the “self-pay” rate in order to receive this testing today.

I, the undersigned, understand that Newport Center Urgent Care, Bryan Doonan, MD and associates are not liable for any false positive and/or false negative test results.

I, the undersigned, also acknowledge that in addition to the “self- pay” cost of $100.00 for CareStart™ COVID-19 Antigen test, an office visit and other COVID-19 specimen preparation will be submitted to my insurance and the patient is liable for any deductibles and non-covered charges.

I, the undersigned, acknowledge that Newport Center Urgent Care will report any positive Covid-19 test results to the Orange County Public Health Department

---

IgG/IgM Rapid Antibody Test

The COVID-19 IgG/IgM Rapid Test Device is the first FDA Emergency Use Authorized Rapid, Point-of-Care, CLIA Waived COVID-19 antibody test. This test is used for the detection of anti-SARS-CoV-2 IgM and IgG antibodies in human whole blood, serum, or plasma samples. This test has been authorized for use with fingerstick blood, intended for identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection to the disease. 

Antibody tests should not be used to diagnose a current COVID-19 infection, except in instances in which viral testing is delayed. An antibody test may not show if you have a current COVID-19 infection because it can take 1–3 weeks after infection for your body to make antibodies.

Whether you test positive or negative for COVID-19 on a viral or an antibody test, you still should take steps to protect yourself and others.

We do not know yet if people who recover from COVID-19 can get infected again. Scientists are working to understand this.

If you test positive: 
A positive test result shows you may have antibodies from an infection with the virus that causes COVID-19. However, there is a chance that a positive result means you have antibodies from an infection with a different virus from the same family of viruses (called coronaviruses). Note: Other coronaviruses cannot produce a positive result on a viral test (swab) for SARS-CoV-19.

Having antibodies to the virus that causes COVID-19 may provide protection from getting infected with the virus again. But even if it does, we do not know how much protection the antibodies may provide or how long this protection may last.

Talk with your healthcare provider about your test result and the type of test you took to understand what your result means. Your provider may suggest you take a second type of antibody test to see if the first test was accurate.

You should continue to protect yourself and others since you could get infected with the virus again.

If you work in a job where you wear personal protective equipment (PPE), continue wearing PPE.
You may test positive for antibodies even if you have never had symptoms of COVID-19. This can happen if you had an infection without symptoms, which is called an asymptomatic infection.

If you test negative:
You may not have ever had COVID-19. Talk with your healthcare provider about your test result and the type of test you took to understand what your result means.

You could have a current infection.
The test may be negative because it typically takes 1–3 weeks after infection for your body to make antibodies. It’s possible you could still get sick if you have been exposed to the virus recently. This means you could still spread the virus.

Some people may take even longer to develop antibodies, and some people who are infected may not ever develop antibodies.
If you get symptoms after the antibody test, you might need another test called a viral test. Viral tests identify the virus in samples from your respiratory system, such as a swab from the inside of your nose.
Regardless of whether you test positive or negative, the results do not confirm whether you are able to spread the virus that causes COVID-19. Until we know more, continue to take steps to protect yourself and others.

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.


• * For use under an Emergency Use Authorization Only. 


• This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests. 

The Assure COVID-19 IgG/IgM Rapid Test Device will only indicate the presence of SARS-CoV-2 antibodies in the specimen and is not used for the diagnosis of acute SARS-CoV-2.dz

* Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Antibodies may not be detected in the first few days of infection; the sensitivity of the Assure COVID-19 IgG/IgM Rapid Test Device early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response 

*It is unknown at this time if the presence of antibodies to SARS-CoV-2 confers immunity to reinfection.  

* A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected. 

* Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

At the time of this signed form, At the time of this signed form, the CPT/HCPCS code for this procedure/service is not adequately paid by commercial insurances.

I, the undersigned, also acknowledge that in addition to the “self- pay” cost of $50.00 for the Rapid COVID-19 Antibody test, an office visit and other COVID-19 specimen preparation will be submitted to my insurance and the patient is liable for any deductibles and non-covered charges