In-Vitro Diagnostics


 Tests done on samples such as blood or tissue that have been taken from the human body to detect disease, conditions, and infections (e.g., testing for SARS-CoV-2 in saliva and nasal swabs). (1) 

There are three forms of IVDs: diagnostic tests, serology/antibody tests, and tests for management. Diagnostic tests detect the presence of the disease or infection. Serology/antibody tests can used to detect if an immune response has ever been mounted against a particular disease or infection. Lastly, tests for management are used to measure biomarkers and determine what treatment should be used for a patient (e.g., biomarkers for inflammation). 



Test developers are largely responsible for the production and distribution of these tests. Diagnostic tests are often prepared in prepackaged boxes for individual use and are used professionals to test patients. Whereas serology/antibody tests and tests for management are used by professionals for patient sampling.  


Depending on the types of test, each is used at different periods in the medical diagnosis. These tests can be conducted at at-home, in-person at testing sites (remote from hospital), and at the hospital. Most often diagnostic tests can be performed at home or hospital-remote sites. Serology/antibody tests usually have to completed at a remote site by a professional or a hospital. Lastly, disease management tests are performed at the hospital. However, there is an instance that will alter this timeline: emergency use authorization (EUA). The FDA states, “Any test developer requesting an EUA that intends to leverage data from another EUA-authorized device must obtain a right of reference to leverage the performance data for that EUA-authorized device. The Centers for Disease Control and Prevention (CDC) has granted a right of reference to the performance data contained in CDC's EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.” The COVID-19 pandemic is a great example of EUA as it applies currently. (2)



In addition to retrieving the EUA as described above these tests much undergo approval by the FDA in the United States. These diagnostic tools are considered medical devices and are thus classified into three classes based on amount of testing required to ensure the test is safe and effective. (3)