The Food and Drug Administration on Saturday authorized emergency use of a new and inexpensive saliva test for Covid-19 that could greatly expand testing capacity.
The new test, which is called SalivaDirect and was developed by researchers at the Yale School of Public Health, allows saliva samples to be collected in any sterile container. It is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. The test also avoids a key step that has caused shortages of chemical reagents used in other tests.
The research team validated SalivaDirect in part by testing NBA players, coaches, and staff, and Yale said the test is now being studied in asymptomatic people through the program with the NBA and its players union.
Get tested and wear a mask.
To understand why this is a potential game changer this article on rapid screening tests.
First, frequent testing catches the vast majority of cases. Someone who is infected but gets a false-negative and slips through the cracks is likely to be caught the next time they’re tested. For a test that misses 20% of positive cases, the chance of an infected person getting two false negatives in a row may be as low as 4%. It’s like bailing a boat with a leaky bucket: You just have to bail more quickly to get the job done.
Second, most people who get false-negative results are unlikely to be contagious. Antigen-based screening tests are good at detecting the high virus levels needed to be contagious. By design, screening tests sacrifice accuracy where it matters least to achieve low costs, speed and ease of use.
AND I learned that the SalivaDirect test was funded by the NBA.
“My goal is not to test athletes,” Grubaugh said. “That’s not my target population. My target population is everybody. There were concerns about partnering with the NBA when all these other people need testing. But the simple answer ended up being the NBA was going to do all this testing anyway, so why not partner with them and try to create something for everyone?”
The NBA, Yale and the players’ association do not intend to take royalties from any use of the testing method, Grubaugh and others said. The NBA and union contributed more than $500,000 combined to fund the Yale work, sources told ESPN.
Testosterone and other AAS, which have a schedule III classification by the Controlled Substances Act, may be abused by adults and adolescents, including athletes and body builders.
“Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system,” the FDA notes.
Reported serious adverse outcomes include myocardial infarction, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. People abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia, the agency says.
It is interesting you no longer see those Low-T commercials on television any more. Really? Just another clever marketing campaign to create a disease that doesn’t exist along with a convenient drug based solution. What side effects?
Read this book. Now.
If I’m understanding this correctly we now have an anti-depressant combined with a drug originally approved for treating opioid, then alcohol addiction, approved by the FDA to treat obesity.
This will be interesting.
Obesity drugs have side effects. The reason it’s taken three years for the FDA to approve NB32/Contrave is that obesity drugs have serious side effects. So serious, in fact, that several major diet drugs have been yanked from the market, making doctors, regulators and yes, investors shy away. Cardiovascular disease and mood problems are just two of the potentially serious side effects associated with Qsymia and Belviq. Older drugs Xenical and Alli carry a risk of permanent liver and kidney damage. And those weight loss supplements you buy over the counter? Some are deadly.
Like I said, this will be interesting.
A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.
I routinely check the FDA drug safety information for personal reasons. One thing led to another, thus the reason for the CYP3A4 link. If you like puzzles, try to figure out why I’m reading up on CYP3A4. My son the molecular biochemist soon to be MD would have no problem figuring this out.
Memory permitting I will link to this FDA webpage on a regular basis. From my perspective the adverse reactions are the most interesting nuggets of information.
ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.