What are in vitro diagnostic (IVD) tests?

An in vitro diagnostic is a test that is completed outside the human body that looks for a certain property to diagnose an illness. Examples of IVD tests include testing nasal fluids (collected on nasal swabs) for respiratory infections, testing urine for pregnancy, testing blood for lipids, or testing tissue for cancer. Some IVD tests are available for use at-home while other tests must be used by trained professionals.  

Are IVD tests safe and accurate?

The United States FDA (Food and Drug Administration) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.1
One of the roles the FDA plays is to ensure the safety and accuracy of new IVD tests (medical devices) before they can be sold. IVD tests are not perfectly accurate, and some tests can change in accuracy as viruses mutate, however the FDA reviews accuracy data for any new test before it can be sold. 
1 https://www.fda.gov/about-fda/what-we-do

How does a new IVD get FDA approval to be sold?

In order to be approved for use, a new IVD test must prove that it is safe and that it has some benefit over other IVD tests that are already approved. To prove the test is safe and accurate, the FDA requires the new IVD to be tested at multiple clinical research offices. Clinical research offices, like Koch Family Medicine, look for patients that fit the profile of an expected user for the new IVD and offer them to participate in the clinical trial. Data is collected from the study participants and provided to the FDA so they can decide if the new IVD is safe and accurate enough to be approved.

What information and samples are collected from a participant during a clinical trial?

Each study varies in the requirements, however the goal of every study is to collect as little information and be as non-invasive, as possible, while still collecting the required information to make a good decision on if/how the IVD should be used.
The only samples that will be collected will directly relate to what is tested using the IVD. The most common samples collected at Koch Family Medicine are nasal swabs (for COVID, Flu, or RSV testing), throat swabs (for strep throat testing), venous blood draws or finger pricks (for a variety of blood tests).
Data collected for IVD studies is typically limited to demographics, any current medications, vaccine history, and any symptoms/diagnoses related to the IVD test. If the IVD test is designed for at-home use, we will also collect user feedback on the ease-of-use of the test.
Your contact information will be collected by Koch Family Medicine, however it is NEVER shared with the FDA or anyone else that is part of the study. Your privacy and confidentiality are always of utmost importance and all information will be de-identified, using only a number to identify your documentation.

Why do participants get paid for participating in Koch Family Medicine clinical trials?

Participants are always paid for their time and travel when helping with Koch Family Medicine clinical trials. The IVD developer needs data and samples from participants like you in order to have the IVD approved by the FDA, and they realize that it will take time and could be an inconvenience to your schedule. To compensate you for this, they provide a stipend that is paid at the completion of your visit. Koch Family Medicine is also compensated by the IVD developer to help identify patients and collect data/samples.

What is the process for participating in a IVD clinical trial at Koch Family Medicine?

1. Let anyone at Koch Family Medicine know that you are interested in joining a specific trial. If calling our office, contact our Research Staff directly at 309-291-0585.
2. Someone from the Koch Clinical Research Staff will contact you to review the criteria to join the study and to go over the study procedures.
3. If you qualify for the study, and are still interested in participating, Koch Clinical Research Staff will schedule an appointment with you to participate in the study at our office.
4. The first thing that will happen during your appointment will be to go over an "Informed Consent" document which will outline the study procedures and will require your signature before we can continue.
5. Our staff will review the criteria to join the study (again) to make sure you qualify before collecting any other study-related information or samples.
6. We will collect any required information and samples. For some studies, you will collect the sample yourself and perform the test yourself so that you can provide feedback on its ease-of-use.
7. Most studies for IVD devices only require a single visit, taking 30-60 minutes, and will not require any follow-up. At the conclusion of your visit, you will be paid for your time and travel.​