A recent survey by data and analytics company GlobalData of 2,243 Verdict Medical Devices readers, found that 64 percent of people think a lack of widespread access to diagnostic testing has greatly exacerbated the spread of the disease.
Verdict Medical Devices writer Chloe Kent commented: “The U.S. Centers for Disease Control and Prevention (CDC) statistics say just over 22,000 specimens or nose swabs have been taken in the U.S. since the beginning of the outbreak, falling far behind other developed countries. Since the first case of coronavirus was identified in the U.S. on January 20, the government response in creating and distributing diagnostic testing has hit roadblock after roadblock. While the World Health Organization began shipping out diagnostic tests developed in Germany to 159 labs around the world on January 17, the U.S. opted to develop its own test, which wasn’t approved by the U.S. Food and Drug Administration (FDA) until February 4."
“The CDC tests then began to deliver inconclusive results during verification due to a problem with one of the chemicals ingredients needed to identify the virus. This meant that until new tests could reach healthcare providers, samples had to be sent to the CDC in Atlanta to confirm any diagnoses, causing a delay of up to 48 hours between testing and confirmation," Kent continued. “Academic hospital labs also weren’t allowed begin working on their own tests until February 29. Private firms have now begun to pick up some of the testing slack from the CDC. On March 9 a long-term care facility in Seattle, which has become home to one of the biggest coronavirus outbreaks in the U.S., reported that it didn’t have enough testing kits for 65 symptomatic employees. Only around a third of the residents at the Life Care Center in Washington now remain after 25 residents died from illness caused by Covid-19."
“Aytu BioScience said on March 10 that is has exclusively licensed the U.S. distribution rights for a point-of-care Covid-19 test developed by China’s Zhejiang Orient Gene Biotech," Kent concluded. "The test, which provides results in two to ten minutes, is already CE marked and Aytu has said it plans to pursue its FDA clearance through emergency use authorization. If it can be rolled out across the U.S. within the next few weeks, it could be crucial in slowing the spread of the disease—but with new cases surging outside of China, the clock is ticking.”