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Considered the coronavirus holy grail, antibodies are believed to give us some level of immunity from the virus. They form after a person fights off COVID-19 and can be detected through a serological test, better known as an antibody test. "There are some really great companies building antibody tests, and there are some not so great, bad actors, building antibody tests. So you have to be really careful," says Jon Carder, co-founder and CEO of Vessel, a San Diego company created four years ago to provide in-home wellness tests. Early in the pandemic, the U.S. Food and Drug Administration allowed these tests to be sold and distributed without federal review, as long as the company notified the FDA it was offering a test, performed self-validation studies, and included a disclaimer on the test results. The FDA is now cracking down on the bad actors, creating a list of tests that should no longer be distributed. Only a handful of manufacturers have been granted FDA Emergency Use Authorization, meeting a certain threshold for accuracy.Carder says states and even countries have been fooled by the bad actors, purchasing inadequate tests. "We were talking to a city government, a big city, and were blown away when we got a response that they were thinking about buying antibody tests from a certain manufacture who had claimed they were FDA approved. And the state had sort of taken their word for it, and they weren't," said Carder. Vessel had been preparing to release its in-home wellness tracker, which tests for health markers like vitamins, minerals, toxins, and cortisol. When the pandemic hit, the company adapted its technology to be used in the fight against COVID-19. "We take existing antibody tests, the good ones, the ones that are accurate and that the FDA has approved for emergency use, and we enable those to be done safely and accurately at home," said Carder. They've created a kit with step-by-step instructions to do the blood test at home. The test card is then scanned through the Vessel app and provides results from a medical professional within a half-hour. The FDA has already approved in-home tests to diagnose active infections – but Carder says the sample must be sent to a lab, and the user must have symptoms or another qualification to get one. And he says they can be costly. "Ours could be one of the first, or the first, antibody test done at home, no lab needed," said Carder. Just this week, the FDA issued three warning letters to companies making false claims on their in-home antibody tests.Vessel has completed its usability studies and is now in clinical trials with the FDA. "Our job is to prove it can be done safely at home and to show that via clinical trials. The FDA really makes the call if they're going to enable antibody testing at home," said Carder. He says the test would be cost-effective, anywhere from -, or around with medical consultation. If approved by the FDA, Carder estimates millions of people could be tested within the first few months. "There's something really great about the peace-of-mind that comes from doing a test, and that may be one of the biggest benefits," said Carder. But while the FDA is only approving the most accurate tests, none are 100 percent accurate and could still lead to false positives. 3314
COMPTON (KGTV) - Two Los Angeles County Sheriff's deputies were shot at a Compton train station late Saturday in what the department is calling an ambush-style attack.A 24-year-old male deputy and 31-year-old female deputy were shot as they sat inside their patrol vehicle at the Metro Blue Line station at Willowbrook Ave. and Oak St. just before 7 p.m., according to the department.The department said both deputies sustained multiple gunshot wounds and were taken to St. Francis Medical Center, where they underwent surgery. Both deputies were out of surgery as of 10:30 p.m., but their conditions remained critical."They are both still fighting for their lives, so please keep them in your thoughts and prayers," LASD wrote on social media.RELATED: San Diego law enforcement agencies voice support for Los Angeles deputies shot during ambush 853
Click here to learn more about the classes being offered by San Diego Continuing Education. Anyone in San Diego is eligible to enroll in one of 75 different certificate programs, ranging from computer programming to welding. Summer sessions begin on June 8. 266
CNN and the New York Times both reported on Friday that Vice President Mike Pence’s several members of the Secret Service’s team tested positive for the virus during his recent trip to Arizona.CNN reported that eight members of Pence’s team had positive COVID-19 tests. Meanwhile, the New York Times reported that two members of Pence’s Secret Service travel team tested positive.The Secret Service has not confirmed the reports.Pence had planned an event in Yuma, Arizona, on Tuesday. Instead, Pence made a brief visit to Phoenix on Wednesday to meet with public health officials.CNN reported that the eight members of Pence’s team remained holed up in Arizona as of Friday evening, citing two sources.The reports come as both Pence and President Donald Trump have ramped up their public schedules, holding rallies and public events. The events come after both Pence and Trump largely remained in the Washington, D.C.., area during the spring as the coronavirus began to spread in earnest nationally.As Friday’s reports surfaced, Trump, along with the usual large contingent of Secret Service employees, traveled to Mount Rushmore for a firework display. 1164
CLEVELAND — A skyscraper in Cleveland was lit up Tuesday morning with the Biden-Harris campaign logo ahead of the first presidential debate, which will take place Tuesday evening.Douglas E. Price III, CEO of K&D Management Group, which owns the Terminal Tower, said the placement of the "Biden-Harris" projection was unauthorized and that the group does not endorse any candidate.“It saddens me that someone would hijack Terminal Tower for political purposes. K&D Group supports many good causes with our lighting displays. We always strive to be non-political," Price said.The United Steelworkers Union claimed credit for the vigilante projection. 664