Co-Diagnostics has developed a diagnostic test for COVID-19 that gives a diagnosis in 90 minutes. The medical testing company has been supplying its COVID-19 diagnostic test kits throughout Europe, and they have been helping European laboratories to speed up the diagnosis of novel coronavirus infections. However, the company has been prevented from selling the testing kits in the United States as they have yet to receive approval by the U.S Food and Drug Administration (FDA).
However, as the number of cases of COVID-19 have increased in the United States, the FDA changed its stance. Under Clinical Laboratory Improvement Amendments (CLIA) guidelines, certified laboratories in the United States can use diagnostic testing kits that have not yet been approved by the FDA. Last weekend, under those guidelines, the FDA has allowed the Co-Diagnostic tests to be supplied to U.S labs to help speed up diagnosis of the disease. It is hoped that faster diagnosis will help to prevent the spread of the disease.
Co-Diagnostics COVID-19 testing kits can be produced in its Utah facility at a rate of around 50,000 kits a day, which should be sufficient to meet demand.
The diagnostic tests require nasal fluid or a swab from a potentially infected patient, which is then analyzed using AI algorithms which can deliver an accurate result in around 90 minutes.
Currently the U.S. Centers for Disease Control and Prevention are using a test it developed to screen patients. Around 3,600 people have been tested so far but given the speed at which the disease is spreading, testing needs to be scaled up dramatically. CDC testing kits will be supplied in the U.S, with members of the Association of Public Health Laboratories in the United States opting to use the CDC kits rather than those developed by Co-Diagnostics.
Co-Diagnostics is not the only company to have developed AI-based testing kits for COVID-19. This week, Alibaba has announced that it has developed an AI-based diagnostic test for COVID-19 that can deliver a result within 20 seconds. The caveat is the system requires computed tomography images in order to diagnose a novel coronavirus infection. According to a recent report in the Nikkei Asian Review, the AI-based system can differentiate between viral pneumonia and COVID-19 with 96% accuracy.
The Alibaba system has been trained using data from more than 5,000 confirmed cases of COVID-19 in China, and with more data the system is expected to become more accurate. Data is being fed into the system from the latest treatment guidelines and published research. The system is expected to be rolled out to around 100 hospitals in China to help them speed up diagnosis of COVID-19 to help contain the disease.