It is important that you read and acknowledge our Policies and Procedures in full.
Your consent is required before testing can be performed.
Policies and Procedures
Payment in full for services and products are due at the time services are performed or products are ordered. As the patient/guarantor, you are financially responsible for any fees and costs associated with any services or products you receive from our office, unless my employer is paying for this screening. This includes any medical service or visit, routine examination, testing (including specifically, COVID 19 IgM/IgG rapid antibody testing and RT-PCR test for SARS- CoV-2 viral nucleic acids in nasal and oral swabs (“Nasal Swab Test”)) and any other screening ordered by the doctor or staff.
Certain screening services may not be considered medically necessary by your health plan. They may be helpful to you, but the terms of your plan may not pay for these services. These non‐ reimbursable services and/or supplies are typically the responsibility of the patient. COVID 19 IgM/IgG rapid antibody and Nasal Swab Test testing is a service not specifically covered under your current health plan contract but is being requested by you.
I understand and agree that it is my responsibility to know if my insurance has any deductible, co-payment, co-insurance, out-of-network, usual and customary limit, prior authorization requirements or any other type of benefit limitation for the services I receive, but regardless I expect no reimbursement for the services rendered today and I agree to make payment in full at the time of service unless my employer is paying for the service.
PRIVACY PATIENT CONSENT FORM/SIGNATURE ON FILE
This notice of privacy provides information about how we may use and disclose protected health information about you. The notice contains a Patient Rights section describing your rights under the law. You have the right to review this Notice before signing this Consent. The term of our Notice may change. If we change our Notice, we will provide any updated notice with future screenings or services.
By signing this form, you consent to our use and disclosure of protected health information about you for treatment, payment and health care operations, and/or as required by law. You have the right to revoke this Consent, in writing, signed by you. However, such revocation shall not affect any disclosures we have already made in compliance with your prior Consent. COVID Rapid Test – Texas LLC its agents, officers, members and employees and its managed sites and physicians provides this form to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The patient understands:
- Protected health information may be disclosed or used for treatment, billing, health care operations and/or as required by law.
- COVID Rapid Test – Texas LLC its agents, officers, members and employees and its managed sites and physicians has a Summary Notice of Privacy Practices and that the patient has the opportunity to review this notice.
- The patient has the right to be informed when their PHI is believed to have been breached.
- The patient is allowed to restrict PHI disclosure to their health plan if the patient is agreeing to pay out of pocket and in full for services rendered.
- If the patient’s employer is paying for the screening, the patient understands and agrees that the screening test results will be provided to the employer to support employer’s decisions regarding the safety of the workplace.
- We will follow all legal statutes and requirements regarding reporting of results to the applicable state and federal agencies, including the Department of Health for public health surveillance.
- All tests results will be maintained is a secure data base and used on a de-identified basis for research and other purposes, including potentially commercial purposes.
COVID Rapid Test – Texas LLC its agents, officers, members and employees and its managed sites and physicians appreciate your compliance with these policies and procedures. We strive to provide the best care available to you. We are happy to discuss any questions or concerns you have about these policies.
Explanation of the IgM/IgG Rapid Antibody Test for COVID 19
IgM/IgG tests are widely accepted. IgM provides the first line of defense during viral infections followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Therefore, testing of COVID-19 IgM and IgG antibodies is a method for the rapid diagnosis of COVID-19 infection. Furthermore, detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection. However, no clinical test is 100% accurate – there can be false positive or false negative results.
What are immunoglobulin detection-based tests for COVID-19 coronavirus?
Immunoglobulin detection tests are based on the qualitative detection of IgM and IgG that are specifically generated by the body in response to SARS-CoV-2 infection.
IgM is usually the first, specific antibody type generated by the body in response to infection. Then, the IgG antibody type is generated and replaces IgM as the predominant antibody in the response to infection.
IgM and IgG fight infections by targeting specific antigens on the surface of the SARS-nCoV-2 virus.
In general, immunoglobulin tests use specific viral antigens to detect the IgM and/or IgG antibodies against those antigens.
Here is a sample of how the test works:
- Collect 2-3 drops of fresh blood/serum or plasma and place it in a sample container and place 2-3 drops of provided buffer in the same container (cassette)
- The cassette allows the diluted sample to move through the cassette by capillary action
- The cassette has labeled SARS-CoV-2 antigen that may bind chemically with either IgM or IgG; thus, forming an antigen/antibody complexes of antigen/IgG and/or antigen/IgM
- After that reaction, the antigen/antibody product passes over anti-IgM and anti-IgG antibodies that are immobilized in a line within the cassette
- The anti-IgM and/or anti-IgG then will capture the specific complex and signal a result (a red line) if either complex is bound to the immobile anti-IgM or anti-IgG
The results need to be read after 15 minutes and no more than 20 minutes (the test resembles a home pregnancy test in this respect.)
A third line is a control line; it indicates that the test is working properly.
What do the COVID-19 immunoglobulin test results mean?
A total of three detection lines are possible, the control with (C) line appearing when sample has finished flowing through the cassette, indicating the test is complete.
The following are what the results mean:
- Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
- Positive Result, IgM only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
- Positive Result, IgG only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
- Positive Result, IgG and IgM: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.
Immunoglobulin tests for COVID-19 like the one offered here cannot confirm the presence of the virus in your system. It can only tell whether you have been exposed in the past or if you have never been exposed to SARS-CoV-2.
How can you get your COVID-19 infection status?
The goals of mass testing are to accurately test most people to determine their status in relation to this infectious disease so they can go forward with their lives.
The large majority of people fall into the categories below:
- People that have COVID-19, (with or without symptoms),
- Some results may also show whether or not the infected patient’s immune system seems to be responding well or poorly to the virus
- People not yet exposed to the virus
- People that have immunologically responded and have a good antibody response (and possibly may be an antibody donor to help fight the virus in other people),
- People able to go back to work and be unaffected by the virus and currently not transmitting the virus, even if they were positive for the virus at some point in the past.
In most cases, independent of the results of the immunoglobulin tests, the test for the viral genes will be necessary to confirm infection status.
Explanation of the AllplexTM 2019-nCoV Assay
The Allplex™ 2019-nCoV Assay is an in vitro diagnostic (IVD) real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the qualitative detection of SARS-CoV-2 viral nucleic acids in human nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate and sputum specimens from individuals who are suspected of COVID-19 by their health care provider. Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
CONSENT, WAIVER OF LIABILITY, INDEMNIFICATION, AND MEDICAL RELEASE
To be signed by adults undergoing COVID Rapid Test – Texas LLC testing
Consent, Acknowledgment and Assumption of Risk
I fully understand the risks and benefits involved in participating in COVID 19 IgM/IgG Rapid Antibody Testing and Nasal Swab Test and I consent to having the screening performed. I have had all of my questions answered.
I understand that this activity involves certain risks for physical injury. I also understand that there are potential risks of which I may not presently be aware. Because of the dangers of participating in this activity, I recognize the importance and agree to fully comply with the applicable laws, policies, rules and regulations, and any supervisor’s instructions regarding participation in this activity.
I understand that COVID Rapid Test – Texas LLC, its agents, officers, members and employees and its managed sites and physicians does not insure participants in the above-described activity, that any coverage would be through personal insurance, and has no responsibility or liability for injury resulting from this activity.
I voluntarily elect to participate in this activity with knowledge of the danger involved, and I hereby agree to accept and assume any and all risks of property damage, personal injury, or death.
Waiver of Liability and Indemnification:
In consideration for being allowed to voluntarily participate in the above-referenced event, on behalf of myself, my personal representatives, heirs, next of kin, successors and assigns, I forever:
- waive, release, and discharge the COVID Rapid Test – Texas LLC its agents, officers, members and employees and its managed sites and physicians from any and all negligence and liability for my death, disability, personal injury, property damages, property theft or claims of any nature which may hereafter accrue to me, and my estate as a direct or indirect result of my participation in the above referenced activity or event; and
- defend, indemnify, and hold harmless COVID Rapid Test – Texas LLC, its agents, officers, members and employees and its managed sites and physicians, from and against any and all claims of any nature including all costs, expenses and attorneys’ fees, which in any manner result from participant’s actions during this activity or event. I hereby consent to receive medical treatment which may be deemed advisable in the event of injury, accident or illness during this activity or event. This release, indemnification, and waiver shall be construed broadly to provide a release, indemnification, and waiver to the maximum extent permissible under applicable law.
- understand that COVID Rapid Test – Texas LLC its agents, officers, members and employees and its managed sites and clinicians does not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific tests, including
- the COVID Rapid Antibody Test and the Nasal Swab Test, products, procedures, treatments, services, opinions, health care providers or other information that may be contained on or available through this testing service. COVID Rapid Test – Texas LLC its agents, officers, members and employees and its managed sites and physicians ARE NOT RESPONSIBLE NOR LIABLE FOR ANY FALSE POSITIVE RESULTS, FALSE NEGATIVE RESULTS, ADVICE, COURSE OF TREATMENT, DIAGNOSIS OR ANY OTHER INFORMATION, SERVICES OR PRODUCTS THAT YOU OBTAIN THROUGH THIS SERVICE.
- understand that all of the health care clinicians affiliated with COVID Rapid Test – Texas LLC are independent practitioners and may be members of the medical staff at one or more hospitals and are typically neither employees nor agents of the hospitals. In either case, COVID Rapid Test – Texas LLC is not responsible for the care provided by these clinicians.
- I, the undersigned participant, affirm that I am at least 18 years of age and am freely signing this agreement. I have read this form and fully understand that by signing this form I am giving up legal rights and/or remedies which may otherwise be available to me regarding any losses I may sustain as a result of my participation. I agree that if any portion is held invalid, the remainder will continue in full legal force and effect.
I HAVE READ THE ENTIRE DOCUMENT BEFORE SIGNING.