What is done with the blood sample?
The blood sample is used ONLY to run the antibody test. It is NEVER used for any other purpose. The blood sample is destroyed after one time use per the lab protocol of disposal within approximately 30 days. The blood samples are disposed as biohazard material. The lab does not keep blood samples.
Why does the lab keep the blood sample for approximately 30 days?
The blood sample is kept in case the antibody test has to be repeated to meet lab quality standards. We do not want customers to provide a second blood sample which would be inconvenient. We request a minimum of 2 blood circles and preferably 5 blood circles in case a test has to be repeated.
Does ImmunoProfile® store the blood sample?
No. The blood sample is destroyed after one time use per the lab protocol of disposal within approximately 30 days. The blood samples are disposed as biohazard material. The lab does not keep blood samples.
Does ImmunoProfile® conduct DNA or other testing?
No. ImmunoProfile® ONLY conducts antibody testing and no other testing is ever conducted on the blood sample.
Are my test results private?
Yes. Each customer creates their own private and secure customer portal account at the time of purchase with a unique password and login credentials. Thereafter, each time the customer, logs in to the portal a two-factor authentication process is initiated, and only the customer can access their account. When the test results are available the customer will login into their individual customer portal to view their test results. ONLY the customer will determine if they want to share their test results which are available to be viewed on the computer, smartphone, tablet or in PDF format for printing and emailing.
Does ImmunoProfile® sell my information or test results?
No. ImmunoProfile® will NEVER sell your personal information or test results to anyone.
Who has access to my blood sample and test results?
Only authorized personnel have access to the blood sample and ONLY for the purposes of running the antibody test. Non-authorized personnel do NOT have access to the blood samples or to your test results.
How does ImmunoProfile® perform 11 antibody tests from a single drop of blood?
Unlike the now dissolved Theranos Company that tried to test multiple diagnostic categories simultaneously, ImmunoProfile® only focuses on antibody IgG tests that run on proven platforms.
ImmunoProfile® uses a proven U.S. FDA-cleared testing platform that has been used globally for over 20 years by multiple medical diagnostic companies, research facilities and academic institutions. The proprietary assay and test kit are both produced in FDA inspected manufacturing facilities. The antibody test is performed in a CLIA/CAP accredited U.S. laboratory.
Does ImmunoProfile® meet the WHO (World Health Organization) standards?
Yes. Each of the 11 antibody test results are built to the WHO standards. The WHO standards are used to establish the cut-off values for each test to determine the level of protection for each individual test result.
Can I use my Health Insurance to pay for the Antibody Test?
ImmunoProfile® has HSA and FSA approval. You can submit your receipt to your health insurance company but ImmunoProfile® cannot guarantee reimbursement and you are subject to your policy’s deductibles, co-payments, co-insurance and other terms and conditions.
What is an Antibody?
An Antibody is a protective protein produced by the immune system in response to the presence of a foreign substance, called an antigen. Antibodies recognize and latch onto antigens in order to remove them from the body.
Do antibodies decline in their effectiveness over time?
Total antibody levels appear to start declining over a period of time regardless of the age, gender, and health status. Antibody levels decline at different rates for different individuals for each vaccine. Antibody testing is essential to keep yourself informed as to the status to your antibodies.
For more information:
How quickly will I receive my test results?
Your test results, in general take approximately 3 weeks from date of arrival of your dried blood sample card (DBS) to the testing facility. Afterwards you can download your test results report to your computer and smartphone.
Can I provide my test results to entities that request vaccination status?
Yes. Your antibody status shown in your test results demonstrate your body has antibodies for a variety of diseases.
How do I collect my sample from home?
- Your Specimen Collection Kit will come with everything you need including an instruction for use pamphlet to collect a finger prick blood sample at home and safely ship your sample to a CLIA-certified laboratory.
- In order to get your sample to our labs as quickly as possible, we provide a prepaid UPS shipping label. Samples must be collected and returned to a UPS drop box the same day or next day. After collection is complete, ship the collection sample, Monday through Friday, and before the carrier’s last pickup time for the day.
- You can find drop box locations on the UPS website.
How can I track the status of my collection sample shipment?
- You should receive emails from ImmunoProfile® thanking you for your purchase of a Specimen Kit and when your test results are ready at the secure and private portal.
- We recommend making a note of your tracking number on the shipping label so you can track your sample through the UPS website. If you have questions about your shipping status, please reach out to: UPS: 1-888-742-5877
What is a laboratory developed test (LDT)?
- A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.
- For more information please go to: https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
What does CLIA stand for?
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing. Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. There are different types of CLIA certificates, as well as different regulatory requirements, based on the types and complexity of clinical laboratory tests a laboratory conducts. Three federal agencies are responsible for administering the CLIA program: the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role.
ImmunoProfile provides CLIA certified test results.
What does CAP stand for?
CAP stands for the College of American Pathologists and is the leading organization of board certified pathologists. CAP is a membership organization with 75 years of experience in fostering excellence in laboratory testing and laboratory science.
CAP-accreditation means that a lab meets and exceeds the CLIA requirements. Their requirements are detailed for every step in the testing process. On-site inspections are facilitated at the state-level. Besides the accreditation itself, CAP provides tools for proficiency testing, training and continuing education programs, quality control tools, and conducts on-site laboratory inspections every two years.
ImmunoProfile provides CAP certified test results
Can I purchase a Specimen Collection Kit if I am under the age of 18?
“Sorry we cannot sell to you” (we cannot administer test or proceed with login for under 18).
How many Specimen Collection Kits can I purchase and have tested?
Due to the prescription approval process, you may only order one test kit at a time. The checkout process only processes one purchase at time. Complete the entire purchasing process for each kit and then begin the process again for any subsequent purchases. In addition, only persons 18 years or older may purchase one kit at a time per the prescription approval process. Thank you for your understanding from the ImmunoProfile® Team.
Which states in the USA can I purchase a Specimen Collection Kit?
Available in all 50 states including the District of Columbia.