In the world of things going wrong, the latest victim is Autobio Diagnostics’ rapid COVID-19 test coming out of Santa Maria’s Hardy Diagnostics. According to Hardy Diagnostics’ president, Jay Hardy, another company’s test was halted mid-shipment by the Chinese version of the FDA, and Autobio Diagnostics — Hardy’s partner in China — got caught up in the resulting blanket prohibition. Hardy’s company had been ready to ship hundreds of orders of the 15-minute test last week.
Hardy said the Autobio test had been 100 percent proven at Marian Regional Medical Center in Santa Maria, as well as in validation tests in China and Europe, where it is currently in use. Marian conducted 10 tests of positive and negative samples using Autobio’s rapid kit, said laboratory chief Dr. Kevin Ferguson, and all were correct.
Marian, which is part of the large Dignity Health hospital chain, is awaiting a shipment of the 45-minute test from Cepheid today, Ferguson added, a small company in Sunnyvale. It identifies genetic material from the SARS-CoV-2 virus, which is the gold standard to determine COVID-19 infection. Shipments went to sister hospitals last week, Ferguson said, and Marian’s been allocated 180 this week. Whether they’ll get them all is another story, he said, as the quantities are determined by areas most in need. The Dignity group, which includes CommonSpirit Health, has hospitals in New York, which is experiencing a crushing surge of cases and deaths.