COVID-19 TESTING AT INOUT LABS – TERMS AND CONDITIONS
The COVID-19 IgG or IgG and IgM Antibody Test is designed to detect the antibodies that develop in the body following exposure to Coronavirus. Symptoms of COVID-19 are expected to appear 1-14 days following viral exposure.
Primary infection is characterized by the presence of detectable IgM antibodies 3-7 days after the onset of infection. Secondary infection is characterized by the elevation of SARS-COV-2-specific IgG antibodies, which can show up as soon as 14 days following infection.
I understand that if this test shows that I have antibodies to the COVID-19 virus, I am most probably infected, or was previously infected, and could spread this infection to someone else. If the test results are negative for the COVID-19 antibodies, I understand I might still have the virus but that it may be too early to tell by the COIVID-19 antibody test.
I further understand that a positive result does not mean I have COVID-19, but that I have been exposed to the COVID-19 virus and antibodies to that virus are present in my blood.
I have been informed and understand that test results, in a number of cases, may indicate that an individual has antibodies to the virus when the person does not have the antibodies (a false positive result) or that the test may fail to detect that a person has antibodies to the virus when the person does in fact have these antibodies (a false negative result).
FDA defines SARS-CoV-2 antigen tests as those that detect proteins that are part of the SARSCoV-2 virus directly from clinical specimens. Antigen tests are designed to detect proteins from the virus that causes COVID-19 in respiratory specimens, for example nasal swabs. This is the same technology used in your doctor’s office for rapid strep testing. Results are produced in minutes.
I understand that a rapid test (if that is what I have selected) is a screening test, and if the test is negative the manufacturer recommends that laboratory RT-PCR testing be performed to confirm any negative results.
- Quidel Sofia Antigen Fact Sheet for Patients https://www.fda.gov/media/137887/download
- BD Veritor Antigen Fact Sheet for Patients https://www.fda.gov/media/139754/download
COVID-19 RT- PCR TESTING
A COVID-19 RT-PCR (Reverse Transcription Polymerase Chain Reaction) test detects the genetic information of the virus, the RNA. The test is conducted in a laboratory and is the test used to diagnose infection with COVID-19. Samples can be from my nose, throat or saliva, depending on the lab’s FDA Emergency Use Authorization.
- Abbott Alinity Fact Sheet for Patients https://www.fda.gov/media/137981/download
- Quest Diagnostics Fact Sheet for Patients https://www.fda.gov/media/136230/download
- Roche Fact Sheet for Patients https://www.fda.gov/media/136048/download
To comply with Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) document issued on May 11, 2020, issued by the U.S. Department of Health and Human Services along with the Food and Drug Administration (found here: https://www.fda.gov/media/135659/download), the following statements must be included in any test reports using the COVID-19 Antibody Test:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA only for use by the authorized laboratory;
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
- Results from antibody testing should not be used to diagnose or exclude acute SARSCoV-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.
By signing this consent form, I acknowledge that I have been provided with information about this test, about the COVID-19 virus and about CDC Recommendations. I have been given the opportunity to ask questions regarding this information and my questions have been answered.
I understand that InOut Labs requires that all individuals who present for testing must be free of COVID-19 symptoms on the day of testing and for at least 14 days prior.
I have received a copy of InOut Labs’ Notice of Privacy Practices (https://inoutlabs.com/hipaa-policy), as required by HIPAA or I have chosen not to receive a copy.
I have been informed that both my request for the COVID-19 antibody test, RT-PCR Test or Antigen test and the test results are considered confidential and will be released only to me or someone I expressly authorize in writing, except as required or permitted by law. I consent and authorize that such disclosure may be made by fax, mail, direct pick-up or by email. I understand and agree that the services provided by InOut Labs and the test result from the lab will be maintained as confidential, protected health information by InOut Labs as required by Federal and State law.
I further understand that it is my responsibility to consult my own medical professional for the interpretation, analysis, evaluation, and explanation of my test results. I understand that neither InOut Labs nor its clinical authority will analyze, evaluate, critique, review, or otherwise interpret my test results. This service does NOT in any way constitute a doctor / patient relationship.
I agree that InOut Labs, its officers, shareholders, directors, contracted physicians, or its other agents or employees shall not be liable for any claims including, but not limited to, any claim arising out of or related to, inaccurate, un-interpreted, misinterpreted or any results InOut Labs has not received and do hereby expressly forever release and discharge all claims, demands, injuries, damage, actions or causes of action against any and all of the foregoing.
I will not seek to be reimbursed by Medicare, Medicaid, Tricare or any other government insurer/payor for the test(s)performed. I agree that I am personally financially responsible for payment of fees for all tests ordered and collected by InOut Labs at my request.
I understand that a contracted physician of InOut Labs who is licensed under Illinois law to order such testing will order any lab test. I also understand that the actual testing may be performed by a third party laboratory, certified to perform such testing on my specimen collected by InOut Labs.
I understand that, unless otherwise limited by state and federal regulations, and except to the extent that action has been taken which was based on my consent, I may withdraw this consent at any time.
I UNDERSTAND THAT TURNAROUND TIMES FOR LAB-BASED TESTS ARE NOT GUARANTEED.
I UNDERSTAND THAT INOUT LABS WILL NOT CONDUCT TESTS ON INDIVIDUALS WHO ARE EXPERIENCING SYMPTOMS OF COVID-19, AND I CERTIFY THAT I WILL BE HONEST WHEN ASKED IF I HAVE ANY OF THE SYMPTOMS.