FREQUENTLY ASKED QUESTIONS
ABOUT NEUTRALIZING ANTIBODIES
Q: What are Neutralizing Antibodies?
A: Neutralizing antibodies or NAbs are the specific antibodies that allow your bodies immune system to protect themselves against pathogens (organisms that cause disease) In COVID-19 these NAbs prevent penetration of the virus into the cell. You can read more about NAbs here
ABOUT THE NEUTRALIZING ANTIBODY TEST
Q: Why is this test important?
A: It has been clearly shown and acknowledged that vaccine efficacy (immune protection) wanes over time. The level of immune protection can also vary between individuals based on pre-existing conditions and on the type of vaccine (manufacturer) given. NAbs are generated by your immune cells in response to a vaccine or to exposure. This test defines a quantitative (percentage) of Nabs present. The FDA EUA test measuring Nabs defined > 30% as Positive protection against the SARS-CoV-2 virus. Understanding your immune status and level of protection is critical in the decision-making regarding vaccine boosters, getting a vaccine and understanding protection against different variants. It is important to understand that immune protection is not immunity. This is issue has also clearly been defined by the FDA recently – “Immunization: A process by which a person becomes protected against a disease through vaccination.” Any decision making related to the results of this test should be made in consultation with your physician or health care provider.
Q: What is the difference between an Antibody Test and a Neutralizing Antibody test?
A: A common misconception is that antibody tests which are commonly available provide the same information. This is incorrect. Standard antibody tests measure all antibodies, binding and neutralizing. This will give you an idea that you have been exposed to the virus but not the level of your immune protection. This is only defined by the neutralizing antibody test.
Q: What is an FDA EUA test?
A: The Emergency Use Authorization Authority allows the FDA to streamline the approval process for laboratory tests which are deemed as essential countermeasures against public health threats such as the COVID-19 pandemic.
Here a a few links from the FDA site that will explain this process:
Q: What is a Laboratory Developed Test?
A: A Laboratory developed test or LDT are laboratory tests that that are unique or modifications of existing tests. These LDTs are developed by laboratories which have the technical expertise and follow regulatory standards and protocols (CLIA).
Here is a link on the FDA website defining these tests. As noted on the site “LDT’s are important to the continued development of personalized medicine, so it is important that in vitro diagnostics are accurate so that patients and health care providers do not seek unnecessary treatments, delay needed treatments, or become exposed to inappropriate therapies.” An example of an LDT in the Comprehensive Immunity Test is the percentage of protection of against the Delta variant.
ABOUT THE EVE PATIENT APP
Q: What is the EVE Patient App?
A: The EVE Patient App is a HIPAA compliant mobile app available on the Apple App Store and Google Play Store that provides you with with real time secure and private access to your Comprehensive Immunity Test. The app allows you to scan the barcode label for your test, which then connects you directly to the lab processing your test results. The app also has a tracker which follows the test processing in the lab. You will get a notification when the test processing and analysis is complete. The app will provide you with the written test result and an Immunocard ™ which will summarize the immunity test in a visual manner.
Q: Will the EVE Patient App work on my cell phone?
A:You can download the EVE Patient App from the Apple App Store (IOS) and the Google Play Store (Android).
Here are the minimum hardware and software requirements for this app to work:
iOS 12 and above
iPhone 6s size 4.7 inch and above, resolution 750 x 1334 and above
Android OS 6 (Marshmallows) and screen size 5.6” and above
Security and Privacy
Q: What does HIPAA compliance mean?
A: HIPPA is the acronym for the Heath Portability and Accountability Act of 1996 passed by The United States Congress. It is a set of rules and regulations around personal heath care information that providers of healthcare use as a part of the delivery of healthcare in all its forms. The Act sets out how healthcare providers and companies who support healthcare providers handle information including the security required around the transmission and storage of the information as well as the administrative tools needed ensure adherence to the Rules and Regulations.
Link to HIPAA information: https://www.hhs.gov/hipaa
Q: Does anyone have access to my data?
Your specific test information is accessible only by yourself, the medical laboratory and other support personnel in accordance with HIPAA Rules and Regulations around the transmission and storage of personal health care information.