COVID-19 test developers have bioengineered a wide range of new diagnostic technologies, with various configurations and distinguishing attributes. Some of the tests that provide rapid results are differentiated by the following:
- types of sample to be collected for testing (nasal, oral, saliva or blood),
- processes to obtain results (in a laboratory, or on a cartridge or test strip at the point of care),
- duration (minutes, hours or days to obtain results), and
- detection methods (in the channels of a microfluidic chip, or with an optical spectrum reaction, or by a proprietary chemical formulation).
While each test is impressive for its cutting-edge innovation, all must meet regulatory standards for test accuracy, usability, and end-user acceptability.
To evaluate these variables, many of the diagnostic tests introduced through the NIH Rapid Acceleration of Diagnostics (RADxYE) the initiative will be studied by the COVID 19 test clinical studies program, a resource established by the RADxYE Clinical Studies Core. Test us for COVID-19 is supported through federal stimulus funds from Congress to the NIH with a portion going to the Heart, Lung, and Blood Institute (NHLBI) for clinical studies that are part of RADxYE.
He Test us for COVID-19 The program was conceived shortly after RADx.YE launch in April to facilitate clinical studies to test technologies in the real environment. Clinical studies are necessary to show that tests work as intended, both to the satisfaction of the person performing the test (often a doctor) and the person undergoing the test. Another important aspect of the tests being evaluated is test performance, that is, whether the new test has comparable sensitivity and specificity to current FDA-cleared tests.
During a public health emergency such as the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) may allow emergency use of not fully approved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening illnesses, such as during the pandemic. Medical device manufacturers, such as diagnostic test developers whose technologies have been advanced by RADxYE—seek emergency use authorization (EUA) for your diagnostic and detection devices. To defend this special use, they must submit data on their testing to the FDA after the technology is evaluated through RADx.YE Technology.
“Each Test us for COVID-19 “The clinical study is designed differently, to take into account the type of test, supplies needed, modes of implementation, and unique methods of displaying readings,” said Erin Iturriaga, DNP, program officer at the NIH Heart, Lung, and Blood Institute, whose expertise lies in clinical trial management, education, and regulatory responsibilities. She is one of many NIH specialists who have taken on important roles in RADx.YEfocusing their attention on addressing the COVID-19 pandemic. “Researchers working with Test us for COVID-19 collect study data that is subsequently used by the test developer to obtain EUAs for an initial use case type or for a use case expanded than its original EUA. “Our researchers pride themselves on being agile enough to adapt to the diversity of evidence.”
The COVID-19 Test Us study team provides insight into FDA requirements when a device developer seeks an EUA. Typically, developers must submit data as part of meeting EUA requirements based on how a test is intended to be used, whether, for example, in a school, nursing home, or workplace. The FDA also expects to receive data that represents how the test works in various age groups, including children and older adults, and from a balance of men and women, and an otherwise diverse population. The team designs studies not only for the first intended use of a test, but also for expanded or modified EUAs, such as when an already approved test is proposed to be used with a sample type (whether saliva, nasal, or blood) that is different from the original EUA.
“Test us for COVID-19 Study design experts sit down with a company representative to discuss their goals for the trial study,” said Jue Chen, Ph.D., an NHLBI program officer who has also been working with RADx.YE Tech, adding that the core clinical trials team and the company are represented in this discussion by their respective regulatory experts. “The data is captured for the company to use in its request for an initial EUA or a modified EUA.” Together, they design a study that measures the usability and acceptability of diagnostic tests, and the accuracy of the test. During the clinical study, both the person administering the diagnostic test and the person being examined answer a questionnaire.
All de-identified data collected by the Test us for COVID-19 The program is stored in a HIPAA– and an FDA-compliant server, called COVID-19 NIH Data Hub, for data sharing. This secure cloud-based research center can facilitate machine learning along with other COVID-19 data. “In addition to age group and ethnicity, we also collected data elements, such as whether a participant is a smoker or vaper,” Iturriaga said. “Even before we were asked, we knew it would be important to gather information for future research.”
Test us for COVID-19 works with a Community Health Engagement team to recruit participants for studies and raise public awareness. Recruitment occurs in various ways at community outreach events, nursing homes, schools, and by invitation to individuals scheduled for medical procedures. Participation is currently limited to those who reside in the vicinity of the partner institutions, which are located in central Massachusetts (University of Massachusetts Medical School), metropolitan Atlanta (Emory University), East Baltimore (Johns Hopkins University), and Evanston, Illinois (Northwestern University). Future clinical studies may involve more locations and even at-home testing.
He Test us for COVID-19 website, covid19testus.orgprovides information about clinical trial research for potential participants in COVID-19 testing studies. Participants may also learn about opportunities to join a study through public service announcements that air on local radio stations. The program includes a pediatric component for studies that include children, called COVID-19 testing, children.
Test developers, Test us for COVID-19 Study design experts and community participants have essential roles to play in the rapid deployment of COVID-19 testing that will help the nation return to school and work.
