GOPATH Patient Consent Form for SARS-CoV-2

Antibody Assessment

Reliant.MD Medical Associates, PLLC, the healthcare provider for the MDBox application (“Healthcare Provider”), is using Gopath Laboratories, LLC (“Laboratory”) to adminsiter the SARS-CoV-2 antibodies test for its patients using a rapid antibody laboratory test for the detection of Coronavirus SARS-CoV-2 antibodies. The Laboratory will then provide the results of the test to your Healthcare Provider.

The Food and Drug Administration (FDA) does not object to the use of these tests in the United States at this time so long as the manufacturer has validated the tests, notified the FDA of their intent to distribute the tests and the tests contain the following warnings:
 

  • 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. · Not for the screening of donated blood

Although this test is not able to detect early infection with SARS-CoV-2, it may be helpful to determine whether you have been exposed to the virus and/or whether any symptoms you have are due to infection with SAR-CoV-2. Your Healthcare Provider will review the information in your medical history and from your telemedicine visit along with the results of the antibody assessment to decide what is best for your medical care.

Since the FDA has not reviewed these tests and therefore has not approved them at this
time, the tests are considered high complexity. In accordance with current laws and regulations, a CLIA certified lab, certified for high complexity tests, must provide the necessary oversight and processing of these tests. The Laboratory is a CLIA certified lab for high complexity.

BACKGROUND
COVID-19 is a respiratory illness that can begin as fever, cough and shortness of breath. It may progress to severe infection and respiratory distress. COVID-19 seems to be spread by close person to person contact. This can occur when a person who is sick with COVID-19 coughs or sneezes onto themselves, other people, or nearby surfaces. Droplets from the
cough or sneeze can travel a short distance through the air and land on the mouth, nose, or eyes of persons who are nearby. The virus also can spread when a person touches a surface or object with infectious droplets and then touches his or her mouth, nose, or eye(s). It also is possible that COVID-19 can be spread through the air or by other ways that we don’t yet know about.

ARE THERE ANY BENEFITS FROM THE TEST?
There may be no direct benefits to you from having this test done. This test may help to determine if you have been exposed to the SARS-CoV-2 virus by detecting the presence of antibodies to the virus. If people with the COVID-19 limit contact with other people, this may prevent others from getting sick. By having this test done, you may lower the chance of spreading the virus from you to your family or others. Use of this test could also help us to know more about this virus to help limit the spread of this illness. The results of this assessment, along with other information, may help your healthcare provider make better medical decisions on your behalf.

IF THIS TEST IS POSITIVE, DOES THAT MEAN I HAVE COVID-19, AND WHAT ARE THE RISKS OF A POSITIVE RESULT?

A positive test is indicative of the fact that you have been exposed to the SARS-CoV-2 virus. There is a very small chance that this test may give a positive result when you have not actually been exposed to SARS-CoV-2 (false positive). If your result from this test is positive:

  1. Your Healthcare Provider may ask to limit contact outside the home by not going to work, school, out-of-home childcare, church, or other public areas. You may also be asked to use a mask at home to limit the risk of spread of the virus. If you have had symptoms of COVID-19, you might be asked to follow these limits because of these symptoms and not because of the test results. If your test results are positive, there is a small chance that you may be asked to follow these limits even if you do not seem to be ill.

  2. There is no proven treatment for COVID-19 at this time. If you are very ill you may be advised to seek emergency medical treatment.

  3. Your Healthcare Provider may decide how to care for you based on the test results along with other factors.

IF THIS TEST IS NEGATIVE, DOES THAT MEAN I DO NOT HAVE COVID-19?
A negative test is indicative of the fact that you do not currently have antibodies in your blood for the SARS-CoV-2 virus. This test may give a negative result when you actually have been exposed to or had an infection with SARS-CoV-2 virus (false negative). A
false negative could result from using this test too early, before your body has developed antibodies or if the amount of antibody in your blood is below the threshold of detection for this test. A false negative result should not have an effect on your care. CDC has told doctors and healthcare providers that a negative test does not prove by 100% that a person does or does not have the SARS-CoV-2 virus.

ARE THERE ANY RISKS FROM TAKING MY BLOOD SAMPLE?
To do this test, a small sample of blood will be taken by a finger prick test.
When we take your blood, the needle poke may pinch or sting or cause very mild bruising or bleeding.

WHAT ABOUT PRIVACY?
We will keep all facts about you as private as the law allows. If your test result is positive, it will be submitted to the CDC and the Local/State Health Department.

RIGHT TO REFUSE
It is your choice to have this testing done on you. If you refuse to have the testing done, you will not lose the right to get health care because of not having results from these tests.

WHOM TO CALL IF YOU HAVE QUESTIONS
Please call 1- 855-GOPATH9 (1-855-467-2849) if you have any questions.

For the most up to date information on COVID19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage: https://www.cdc.gov/COVID19

CONSENT STATEMENT

I agree that this laboratory testing may be done on the samples collected from me.

I have read the above and have had my questions answered, if any.

I voluntarily agree to testing for COVID-19.

I authorize my test results to be disclosed to the county, state, or to any other governmental entity as may be required by law.

I authorize the laboratory to disclose my results to my Healthcare Provider, Reliant.MD Medical Associates, PLLC.

Patient Consent Form for SARS-CoV 2 Reverse Transcription Polymerase Chain Reaction (RT-PCR) Testing 

Reliant.MD Medical Associates, PLLC, the healthcare provider for the MDBox application, hereinafter referred to as MDBox, is using a laboratory test called a Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) to test for SARS-CoV2, the virus that causes COVID-19. Consent Form contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. If you have questions or would like to discuss the information provided after you read this consent form, please talk to your MDBox healthcare provider. 

 

MDBox is using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device to collect a patient’s saliva.  The patient will collect the saliva and then send it to MDBox, who will forward the collected saliva to an outside laboratory called SoftCell Laboratory (“SCL”) to process the test using the SoftCell Laboratories TaqPath SARSCoV-2 Assay. In some circumstances, MDBox may direct the patient to send the collected saliva directly to SCL. The SCL will then provide the results of the test to your MDBox provider when they become available.

 

WHAT IS THE SoftCell Laboratories TaqPath SARSCoV-2 Assay? It is a test is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal, oral swabs or saliva. You will be tested using the collection of saliva fluid utilizing the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This fluid will be sent out to the laboratory that can extract the virus’s RNA. The virus that causes Covid-19, SARS-CoV-2, is an RNA virus, which means it uses ribonucleic acid as its genetic code. The virus infects a cell and uses a process called reverse transcription, or RT to cause the cell to make more viruses. Because there’s not very much material in one nasal swab sample, a polymerase chain reaction (PCR) is used to rapidly make billions of copies so it can be analyzed, and the virus can be detected. This test is not yet approved or cleared by the United States Federal Drug Administration (FDA). When there are no FDA-approved or cleared tests available, and other conditions are met, the FDA can make tests available under an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service (HHS) which has made the declaration that circumstances exist to justify the emergency use of in vitro diagnostics (lab tests using samples from a person) for the detection and/or diagnosis of COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

 

 

BACKGROUND

COVID-19 is a respiratory illness that can begin as fever, cough and shortness of breath. It may progress to severe infection and respiratory distress. COVID-19 seems to be spread by close person to person contact. This can occur when a person who is sick with COVID-19 coughs or sneezes onto themselves, other people, or nearby surfaces. Droplets from the cough or sneeze can travel a short distance through the air and land on the mouth, nose, or eyes of persons who are nearby. The virus also can spread when a person touches a surface or object with infectious droplets and then touches his or her mouth, nose, or eye(s). It also is possible that COVID-19 can be spread through the air or by other ways that we don’t yet know about.

 

 

 

WHO SHOULD BE TESTED?

You should be tested if you meet one of the more of following reasons: 

  1. You are a first responder or a healthcare worker who may have been exposed to someone who has the disease.

  2. You may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing). 

  3. You live in or have recently traveled to a place where there are known cases of COVID-19. 

  4. You have been in close contact with an individual suspected of or confirmed to have COVID-19. 

 

ARE THERE ANY BENEFITS FROM THE TEST?

There may be no direct benefits to you from having this test done. The results of this assessment, along with other information, may help your MDBox provider make better medical decisions on your behalf. If people with the COVID-19 limit contact with other people, this may prevent others from getting sick. By having this test done, you may lower the chance of spreading the virus from you to your family or others. Use of this test could also help us to know more about this virus to help limit the spread of this illness. 

 

IF THIS TEST IS POSITIVE, DOES THAT MEAN I HAVE COVID-19, AND WHAT ARE THE RISKS OF A POSITIVE RESULT?

If you have a positive test result, it is likely that you have COVID-19. There is a very small chance that this test may give a positive result that is wrong (false positive). If your result from this test is positive:

 

  1. It is likely that you may be placed in isolation to avoid spreading the virus to others. You will be asked to limit contact outside the home by not going to work, school, out-of-home childcare, church, or other public areas. You may also be asked to use a mask at home to limit the risk of spread of the virus. If you have had symptoms of COVID-19, you might be asked to follow these limits because of these symptoms and not because of the test results. If your test results are positive, you may be asked to follow these limits even if you do not seem to be ill.

  2. There is no proven treatment for COVID-19 at this time. If you are very ill you will be advised to seek emergency medical treatment.

  3. Your MDBox provider may decide how to care for you based on the test results along with other factors.

 

IF THIS TEST IS NEGATIVE, DOES THAT MEAN I DO NOT HAVE COVID-19?

A negative test result means that the virus that causes COVID-19 was not found in your sample. For COVID-19, a negative test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your illness. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with your symptoms, possible exposures, and geographical location of places you have recently traveled, in deciding how to care for you. It is important that you work with your healthcare provider to help you understand the next steps you should take. 

 

 

 

ARE THERE ANY RISKS ASSOCIATED WITH THIS TEST?

Potential risks include: 

Providing a saliva sample does not pose any physical risk. Possible incorrect test result, including a false positive or a false negative. The RT-PCR is not a rapid test. This means that it will take a few days to get your results.

 

WHAT ABOUT PRIVACY?

We will keep all facts about you as private as the law allows. If your test result is positive, it will be submitted to the CDC and the Local/State Health Department.

 

RIGHT TO REFUSE

It is your choice to have this testing done on you. If you refuse to have the testing done, you

will not lose the right to get health care because of not having results from these tests.

 

WHOM TO CALL IF YOU HAVE QUESTIONS

Please call the MDBox support line at 855-632-6940 if you have any questions about this testing. 

 

For the most up to date information on COVID19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage: https://www.cdc.gov/COVID19 

 

CONSENT STATEMENT

I consent to MDBOX sending my saliva sample to SCL for testing.

I agree that SCL may perform laboratory testing on the samples collected from me.

I voluntarily agree to testing for COVID-19. 

I authorize my test results to be disclosed to the county, state, or to any other governmental entity as may be required by law.

I authorize the SCL to disclose my test results to Reliant.MD Medical Associates, PLLC.

I have read the above and have had my questions answered, if any.

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