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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

COOK COUNTY, Illinois (AP) — A Michigan woman has been charged with murder in the deaths of her newborn twin sons more than 17 years after their bodies were found near Chicago.Authorities said Saturday that 41-year-old Antoinette Briley of Holland, Michigan, has been charged with two counts of first-degree murder for the deaths of her sons.The boys’ bodies were discovered on June 6, 2003, by a waste management employee who was emptying trash bins in Cook County, Illinois. Officers say the worker spotted the bodies in the front lift bucket.“A subsequent autopsy determined the victims were born alive and died of asphyxiation and the deaths were ruled homicides,” said Leo Schmitz, Chief of Public Safety at the Cook County Sheriff's Office, during a press conference.Using DNA technology, detectives eventually identified Briley as the victims’ potential birth mother.As part of their investigation, Schmitz says detectives traveled to Michigan and “obtained discarded items with Briley’s DNA,” which was then matched to the DNA of the newborn victims.On Thursday, officers say they learned Briley was in the Cook County area and took her into custody after a traffic stop in Oaklawn, Illinois. The suspect was transported to the sheriff’s headquarters, where Schmitz says she admitted to the “birth, death, and disposal” of the infants. 1351

COLTON, Calif. (KGTV) - At least five people died Friday afternoon in a fiery crash on Interstate 10 in the San Bernardino County community of Rialto, KABC reported.The California Highway Patrol indicated at least three vehicles and two trucks were involved in the crash that left wreckage on both sides of the freeway at Riverside Ave. about 1 p.m.A big rig heading west veered toward the median, crashed through the center divider and burst into flames, KTLA reported. The truck kept moving across eastbound lanes, striking several vehicles.Five people were killed. The truck driver received only minor injuries and another driver was able to walk away from the crash.After a nearly 16-hour shutdown of the highway, all lanes were reopened Saturday morning, KABC said. The cause of the crash is under investigation.Check traffic HERE.  865

Could the no-calorie sweetener you rely on to replace sugar in your diet actually cause weight gain instead of the weight loss you were expecting?The answer may be yes, according to a new study."Artificial sweeteners are not risk-free," said Brian Hoffmann, assistant professor in the Department of Biomedical Engineering at the Medical College of Wisconsin and Marquette University, and a lead author of the study. "They are a very controversial topic when it comes to health and nutrition ... but they're so prevalent in society that I think we owe it to ourselves to try and figure out what's actually going on."Hoffmann presented his new research Sunday at the annual?Experimental Biology meeting in San Diego. Relying on rats and human cell cultures, his team identified a number of pathways linking artificial sweeteners with metabolic changes at the genetic level that could lead to diabetes and obesity. Specifically, the researchers found that three weeks of exposure to aspartame and acesulfame potassium -- two artificial sweeteners frequently combined in products such as Equal -- altered the expression of certain genes responsible for lipid metabolism in the cells of both rats and humans."Aspartame had some significant changes, and one of those was an increase in lipids in the bloodstream and a decrease in a biomolecule that is involved in clearing (lipids) from the bloodstream. And we saw the exact same thing with the acesulfame potassium," Hoffmann said."We then took those particular sweeteners and put them on endothelial cells -- the cells that line the blood vessels and would be exposed to them in the body -- and we detected a marked dysfunction, suggesting why sweeteners and diet soda have been linked to potential cardiovascular problems," he added.What was perhaps most surprising, according to Hoffmann, was that these metabolic changes did not occur in the presence of natural sugars such as glucose and fructose. This suggests that artificial sweeteners could contribute to metabolic disorders such as diabetes and obesity by an entirely different mechanism than natural sugars, he said.Artificial sweeteners appear to contribute to metabolic disorders by altering the activity of certain genes responsible for the breakdown of macromolecules such as fats and proteins, Hoffmann said. This is different from normal sugars, which contribute to cardiovascular disease through insulin resistance and by damaging the cells lining the body's blood vessels."People are generally consuming non-nutritive sweeteners believing they are a 'healthy choice,' but this may not be true," said research scientist Meghan Azad of the University of Manitoba in Winnipeg, who was not involved in the new study."This is especially important given the widespread and increasing consumption of artificial sweeteners in the general population and the increasing use of artificial sweeteners in our food supply," said Azad, who has authored a paper that reviewed a number of studies on the potential downside of artificial sweeteners on weight and health.According to Azad, over 40% of adult Americans consume no-cal sweeteners on a daily basis, and studies that measure the sweeteners in blood and urine show that many people who report not using artificial sweeteners are unknowingly consuming them.It's the latest assault in the ongoing debate over artificial sweeteners and their impact on health -- a debate that began when one of our most popular foods, sugar, turned sour in terms of health. 3527

Confirmed cases of COVID-19 worldwide surpassed 40 million on Monday morning, according to a database kept by Johns Hopkins University.The United States (8.1 million), India (7.5 million), Brazil (5.2 million) and Russia (1.4 million) lead the world with the highest numbers of cases.Worldwide deaths linked to the virus total 1.1 million worldwide. The U.S. continues to lead the world in deaths linked to the virus with 219,674.The grim milestone comes as case rates around the world are spiking, marking some of the highest daily totals of new cases since the disease began spreading. On Friday alone, 411,337 people around the world were diagnosed with COVID-19 — the most in a single day since the start of the pandemic.The U.S. appears to be among the main drivers of the spike in case rates around the world. After averaging a staggering 90,000+ new cases a day last month, India has made efforts to slow the spread of COVID-19 in recent weeks. Within the past few days, the U.S. surpassed India as the country with the highest rate of new cases, with an average of more than 60,000 a day.Infectious disease experts in the northern hemisphere warn that the coming weeks are vital in slowing the spread of the virus ahead of the winter months. Experts like Dr. Antony Fauci say that it will be much more difficult to stop the spread of COVID-19 as people move activities indoors during colder weather. 1415

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