At-home strep throat test – A clinical study
BLACKFOOT, Idaho (KIFI) – Fargo-based medical startup, Checkable Medical, is conducting a clinical study to prove the safety and effectiveness of an over-the-counter at-home strep test. Once the study is complete and granted FDA clearance, it will be the first and only rapid strep throat test approved for home use.
This groundbreaking evolution in home health care comes just in time after recent reports of a rise in severe strep A infections across US hospitals and after 15 deaths in the United Kingdom.
At-home strep throat tests can help alter the fatality rate due to strep not getting diagnosed in time.
Checkable Medical is hosting clinical trials at several locations across the country including Blackfoot at Elite Clinical Trials.
Checkable is seeking adults and children ages five and older that are presenting two or more strep throat symptoms to be eligible to enroll in the study.
Patients who qualify and consent to the study will be given the at-home test kit and easy-to-follow instructions to perform the test at the healthcare facility. Patients will be asked to answer a short survey on their overall experience using the test. A healthcare provider will then perform the standard diagnostic visit.
Children enrolled in the study will need to have a parent or guardian to perform the test. Adults who enroll in the study will need to bring another healthy adult to perform the throat swab.
Only participants who qualify and have another adult present can participate on testing day.
Upon completion of the study, each patient will receive a $100 Gift Card.
Patty Post, Checkable Medical’s CEO and Founder, says, “Strep throat season is still active across the country, and we want to enroll as many subjects as possible to make at-home strep testing possible. Subjects that enroll in the study are helping advance the use of at-home medical tests, making it easier for everyone to access inexpensive healthcare options so that they can skip trips to the doctor’s office, save time and money and get treatment fast.”
Checkable Medical’s at-home strep test platform will include the test kit and a digital application that trains users on how to take a sample, interpret the results, and, once cleared, patients will be able to use the results of the test to connect with their care providers if treatment is needed.
Strep throat is a common bacterial infection, typically found in school-aged children between five and 15-years-old. Caused by Streptococcus pyogenes, a bacterium that is extremely contagious, strep throat can lead to sinus, tonsil, and ear infections and more severe inflammatory illnesses such as scarlet and rheumatic fever.
By providing at-home tests, Checkable Medical expects to help reduce the burden on healthcare systems and decrease the amount of time and money families spend on clinic visits. These at-home tests will also help reduce the time parents and children need to spend away from work and school.
Once the Checkable Medical strep testing platform receives regulatory clearance, Post says, “You’ll be able to pick up our test at your local pharmacy or online, use it in the comfort of your own home, and get results in 10 minutes, instead of arranging an appointment with your doctor for a strep test and then waiting hours or even days to get results back."
Those that are interested in learning more about the study and how to enroll can visit their website, scan the QR code in the flier or contact Elite Clinical Trials in Blackfoot at (208) 643-0006.
