WASHINGTON — The Food and Drug Administration on Wednesday authorized the first rapid Coronavirus test that doesn’t need any special computer equipment to get results.

The 15-minute test from Abbott Laboratories will sell for $5, giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.

The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.

In general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases, such as when patients have Coronavirus-like symptoms.

(I abbreviated this AP story)

(08-26-2020 09:45 PM)DetroitRocket Wrote:  WASHINGTON — The Food and Drug Administration on Wednesday authorized the first rapid Coronavirus test that doesn’t need any special computer equipment to get results.

The 15-minute test from Abbott Laboratories will sell for $5, giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.

The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.

In general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases, such as when patients have Coronavirus-like symptoms.

(I abbreviated this AP story)

accuracy, and avoiding false positives will be key in any use of such tests

(08-27-2020 09:01 AM)PaulJ Wrote:  

(08-26-2020 09:45 PM)DetroitRocket Wrote:  WASHINGTON — The Food and Drug Administration on Wednesday authorized the first rapid Coronavirus test that doesn’t need any special computer equipment to get results.

The 15-minute test from Abbott Laboratories will sell for $5, giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.

The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.

In general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases, such as when patients have Coronavirus-like symptoms.

(I abbreviated this AP story)

accuracy, and avoiding false positives will be key in any use of such tests

Every rapid strep we have done in clinics has also had a standard throat culture strep due to both false positive and negatives. If there was a treatment as there is for strep even a false positive would allow for treatment to be started. With Covid-19 a false positive allows for quarantine to be started, which can be ended if pcr comes back negative. It comes back to testing, quarantine, contact tracing, social distancing and wearing masks when in groups. If that can't be done efficiently then controlling or containing the virus will be impossible. Remember we only had a couple months of bad weather where people were inside and meeting, if people take their deck, patio, park and backyard parties indoors this fall and winter we could see worse outbreaks than in the spring. Especially with the holidays in November and December primarily being indoor celebrated.

(08-27-2020 10:11 AM)utrocks84 Wrote:  

(08-27-2020 09:01 AM)PaulJ Wrote:  

(08-26-2020 09:45 PM)DetroitRocket Wrote:  WASHINGTON — The Food and Drug Administration on Wednesday authorized the first rapid Coronavirus test that doesn’t need any special computer equipment to get results.

The 15-minute test from Abbott Laboratories will sell for $5, giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.

The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.

In general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases, such as when patients have Coronavirus-like symptoms.

(I abbreviated this AP story)

accuracy, and avoiding false positives will be key in any use of such tests

Every rapid strep we have done in clinics has also had a standard throat culture strep due to both false positive and negatives. If there was a treatment as there is for strep even a false positive would allow for treatment to be started. With Covid-19 a false positive allows for quarantine to be started, which can be ended if pcr comes back negative. It comes back to testing, quarantine, contact tracing, social distancing and wearing masks when in groups. If that can't be done efficiently then controlling or containing the virus will be impossible. Remember we only had a couple months of bad weather where people were inside and meeting, if people take their deck, patio, park and backyard parties indoors this fall and winter we could see worse outbreaks than in the spring. Especially with the holidays in November and December primarily being indoor celebrated.

14 day quarantine can also huge implications for people (work), so would be nice if it was deemed necessary on the most accurate testing, here at UT we can only get PCR on campus if we show symptoms.

(08-27-2020 11:23 AM)PaulJ Wrote:  

(08-27-2020 10:11 AM)utrocks84 Wrote:  

(08-27-2020 09:01 AM)PaulJ Wrote:  

(08-26-2020 09:45 PM)DetroitRocket Wrote:  WASHINGTON — The Food and Drug Administration on Wednesday authorized the first rapid Coronavirus test that doesn’t need any special computer equipment to get results.

The 15-minute test from Abbott Laboratories will sell for $5, giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.

The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.

In general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases, such as when patients have Coronavirus-like symptoms.

(I abbreviated this AP story)

accuracy, and avoiding false positives will be key in any use of such tests

Every rapid strep we have done in clinics has also had a standard throat culture strep due to both false positive and negatives. If there was a treatment as there is for strep even a false positive would allow for treatment to be started. With Covid-19 a false positive allows for quarantine to be started, which can be ended if pcr comes back negative. It comes back to testing, quarantine, contact tracing, social distancing and wearing masks when in groups. If that can't be done efficiently then controlling or containing the virus will be impossible. Remember we only had a couple months of bad weather where people were inside and meeting, if people take their deck, patio, park and backyard parties indoors this fall and winter we could see worse outbreaks than in the spring. Especially with the holidays in November and December primarily being indoor celebrated.

14 day quarantine can also huge implications for people (work), so would be nice if it was deemed necessary on the most accurate testing, here at UT we can only get PCR on campus if we show symptoms.

Agree, but if more accurate test takes 3-10 days to get results you can't have people running around other employees like they aren't infected. At least if you do both at same time you can quarantine until PCR comes back Negative if antigen was positive. Just best practice in any peer reviewed protocol for infectious diseases. If antigen negative there should be isolation at work (mask that is worn properly at all times, maybe at least 6 feet between them and others) until pcr can be resulted. If not things will close again whether we like it or not, as of now these kids aren't showing a lot of symptoms, let staff or aged professors start to become infected. TA's are already concerned. As far as campus, I know OSU is using a different test that is more expensive, but seems to have better turnaround.

(08-27-2020 12:51 PM)utrocks84 Wrote:  

(08-27-2020 11:23 AM)PaulJ Wrote:  

(08-27-2020 10:11 AM)utrocks84 Wrote:  

(08-27-2020 09:01 AM)PaulJ Wrote:  

(08-26-2020 09:45 PM)DetroitRocket Wrote:  WASHINGTON — The Food and Drug Administration on Wednesday authorized the first rapid Coronavirus test that doesn’t need any special computer equipment to get results.

The 15-minute test from Abbott Laboratories will sell for $5, giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.

The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.

In general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases, such as when patients have Coronavirus-like symptoms.

(I abbreviated this AP story)

accuracy, and avoiding false positives will be key in any use of such tests

Every rapid strep we have done in clinics has also had a standard throat culture strep due to both false positive and negatives. If there was a treatment as there is for strep even a false positive would allow for treatment to be started. With Covid-19 a false positive allows for quarantine to be started, which can be ended if pcr comes back negative. It comes back to testing, quarantine, contact tracing, social distancing and wearing masks when in groups. If that can't be done efficiently then controlling or containing the virus will be impossible. Remember we only had a couple months of bad weather where people were inside and meeting, if people take their deck, patio, park and backyard parties indoors this fall and winter we could see worse outbreaks than in the spring. Especially with the holidays in November and December primarily being indoor celebrated.

14 day quarantine can also huge implications for people (work), so would be nice if it was deemed necessary on the most accurate testing, here at UT we can only get PCR on campus if we show symptoms.

Agree, but if more accurate test takes 3-10 days to get results you can't have people running around other employees like they aren't infected. At least if you do both at same time you can quarantine until PCR comes back Negative if antigen was positive. Just best practice in any peer reviewed protocol for infectious diseases. If antigen negative there should be isolation at work (mask that is worn properly at all times, maybe at least 6 feet between them and others) until pcr can be resulted. If not things will close again whether we like it or not, as of now these kids aren't showing a lot of symptoms, let staff or aged professors start to become infected. TA's are already concerned. As far as campus, I know OSU is using a different test that is more expensive, but seems to have better turnaround.

"If antigen negative there should be isolation at work (mask that is worn properly at all times, maybe at least 6 feet between them and others)"

That's already requirement at UT regardless of any test results

https://www.ajc.com/news/university-of-a...A6YAVMPRE/

university of illinois has been doing wholesale testing on campus now for several weeks. basically , trying to test everyone on campus 1-2 times a week. they actually do close 2% of the national tests alone. all the clinical work done on campus. makes you wonder if UT w UTMCO could be doing same thing.

of course, that's just testing, which makes the other stuff easier, but still difficult. the big issue the CDC and most everyone else is missing is ventillation. most people get COVID by breathing it in, yet there is little guidance on ventillation systems. even portable HEPA filtration systems have been game changers for intra-hospital transmission. as far as sports goes indoors it may depend on who has updated their ventillation systems.

(08-27-2020 11:52 PM)pono Wrote:  university of illinois has been doing wholesale testing on campus now for several weeks. basically , trying to test everyone on campus 1-2 times a week. they actually do close 2% of the national tests alone. all the clinical work done on campus. makes you wonder if UT w UTMCO could be doing same thing.

of course, that's just testing, which makes the other stuff easier, but still difficult. the big issue the CDC and most everyone else is missing is ventillation. most people get COVID by breathing it in, yet there is little guidance on ventillation systems. even portable HEPA filtration systems have been game changers for intra-hospital transmission. as far as sports goes indoors it may depend on who has updated their ventillation systems.

Hospitals are building special rooms in which the infected air is rerouted, away from other patients and hospital staff. One way to do this is with a negative pressure room, in which a lower air pressure allows outside air into the room; any air that flows out of the room has to pass through a filter. With these rooms, hospital staff may only need a mask and gown when treating a Covid patient because any infected air is quickly moved out of the room. Football teams could retrofit meeting rooms and locker rooms to lessen any transmission among large groups.

great failure in this country in the response to COVID-19 not to have readily available, accurate testing with results within 24 hrs - only way to effectively detect cases and use contact tracing to stem spread.

great failure here at UT not to test everyone (faculty, staff, students) when they first returned to campus

We have to keep in mind that there was no test for this in the beginning. They had to develop a test first. Then, they needed to have enough antigens for the test and they needed enough laboratories to process the tests. None of those existed because there had never been a human infected with this. Had China not barred our doctors and scientists from coming in right away we would be further along.

couldn't the federal government use defense production act as they did with ventilators or PPE to try and speed production and test kits? Just wondering.

Of course. However, if the antegens didn't exist they didn't exist. There were only so many labs to even process and they did aquire more. Everyone can look back and complsiun it should have happened faster but the entire world was faced with the same exact issue. wasn't just the USA. To blame Trump for the same issue that every single country had at the same time is ridiculous.

(08-29-2020 09:55 AM)utxctrack Wrote:  We have to keep in mind that there was no test for this in the beginning. They had to develop a test first. Then, they needed to have enough antigens for the test and they needed enough laboratories to process the tests. None of those existed because there had never been a human infected with this. Had China not barred our doctors and scientists from coming in right away we would be further along.

China was secretive about the virus for about a month in December when they were more concerned about PR. By the end of December they switched course and realized it could become a pandemic, alerted WHO, and shared info on virus, by January nearby countries were developing rapid tests. First US cases were from Europe, not the Chinese strain, end of January/ early February. Health researchers in Seattle identified the virus and quickly developed a test but we're blocked by federal government from using it. How much of that was regulatory protocol and how much was administration approach to directing all coronavirus response to the market and profit making is unclear but some of both has been documented. Our health care response to the virus has as much to do with China as does Vietnam's or Sweden's or New Zealand's, all of whom got it before us and are managing it pretty well.

Sweden is an interesting choice, knowing their approach. New Zealand is a tiny country that is also an island which made it very unique in its ability to completely close its borders. Of course now they are realizing that you can’t hide from the virus forever.

(08-29-2020 02:47 PM)pono Wrote:  

(08-29-2020 09:55 AM)utxctrack Wrote:  We have to keep in mind that there was no test for this in the beginning. They had to develop a test first. Then, they needed to have enough antigens for the test and they needed enough laboratories to process the tests. None of those existed because there had never been a human infected with this. Had China not barred our doctors and scientists from coming in right away we would be further along.

China was secretive about the virus for about a month in December when they were more concerned about PR. By the end of December they switched course and realized it could become a pandemic, alerted WHO, and shared info on virus, by January nearby countries were developing rapid tests. First US cases were from Europe, not the Chinese strain, end of January/ early February. Health researchers in Seattle identified the virus and quickly developed a test but we're blocked by federal government from using it. How much of that was regulatory protocol and how much was administration approach to directing all coronavirus response to the market and profit making is unclear but some of both has been documented. Our health care response to the virus has as much to do with China as does Vietnam's or Sweden's or New Zealand's, all of whom got it before us and are managing it pretty well.

When you're referring to the government, it's the CDC
and FDA. In the case of S.C.A.N., it was initially a surveilance study not a diagnostic and was under
different requirements than a diagnotistic program.
CDC faulty reagents in their test kits made the situation worse. Obviously in the case of S.C.A.N
less government would of been better. Streamlining
instead of existing regulation.

(08-29-2020 05:51 PM)Boca Rocket Wrote:  

(08-29-2020 02:47 PM)pono Wrote:  

(08-29-2020 09:55 AM)utxctrack Wrote:  We have to keep in mind that there was no test for this in the beginning. They had to develop a test first. Then, they needed to have enough antigens for the test and they needed enough laboratories to process the tests. None of those existed because there had never been a human infected with this. Had China not barred our doctors and scientists from coming in right away we would be further along.

China was secretive about the virus for about a month in December when they were more concerned about PR. By the end of December they switched course and realized it could become a pandemic, alerted WHO, and shared info on virus, by January nearby countries were developing rapid tests. First US cases were from Europe, not the Chinese strain, end of January/ early February. Health researchers in Seattle identified the virus and quickly developed a test but we're blocked by federal government from using it. How much of that was regulatory protocol and how much was administration approach to directing all coronavirus response to the market and profit making is unclear but some of both has been documented. Our health care response to the virus has as much to do with China as does Vietnam's or Sweden's or New Zealand's, all of whom got it before us and are managing it pretty well.

When you're referring to the government, it's the CDC
and FDA. In the case of S.C.A.N., it was initially a surveilance study not a diagnostic and was under
different requirements than a diagnotistic program.
CDC faulty reagents in their test kits made the situation worse. Obviously in the case of S.C.A.N
less government would of been better. Streamlining
instead of existing regulation.

yes, I agree govt public health actions can involve CDC and/or FDA. I wouldn't simplify the missed opportunities of the SCAN scenario as "less government would have been better". More like more government cooperation with local health authorities and more government awareness of the impending pandemic would have been better. The flu study folks in Seattle tried every which way to convince the feds-through multiple offices- that there was a local coronavirus outbreak and they had created testing tools to map and contact trace it. The feds were not interested in responding to either. The president was saying it was a few cases and would go away. The CDC response at that time was coordinated and overseen by a 34 year old dog breeder with no public health training or experience. February, in general, was horror show from a governmental public health management perspective.

And to be broadly fair, the federal govt wasn't the only ones blowing it. There's plenty of blame to go around. My state's DOH didn't develop and implement a solid COVID management plan until last week, and it took firings and reassignments to get people who wanted to do it on board. 3 weeks ago their own headquarters had no security, health screening, mask requirements or social distancing-and these are the people at work to lead the local response.

(08-29-2020 07:51 PM)pono Wrote:  

(08-29-2020 05:51 PM)Boca Rocket Wrote:  

(08-29-2020 02:47 PM)pono Wrote:  [quote='utxctrack' pid='16967707' dateline='1598712903']
We have to keep in mind that there was no test for this in the beginning. They had to develop a test first. Then, they needed to have enough antigens for the test and they needed enough laboratories to process the tests. None of those existed because there had never been a human infected with this. Had China not barred our doctors and scientists from coming in right away we would be further along.

China was secretive about the virus for about a month in December when they were more concerned about PR. By the end of December they switched course and realized it could become a pandemic, alerted WHO, and shared info on virus, by January nearby countries were developing rapid tests. First US cases were from Europe, not the Chinese strain, end of January/ early February. Health researchers in Seattle identified the virus and quickly developed a test but we're blocked by federal government from using it. How much of that was regulatory protocol and how much was administration approach to directing all coronavirus response to the market and profit making is unclear but some of both has been documented. Our health care response to the virus has as much to do with China as does Vietnam's or Sweden's or New Zealand's, all of whom got it before us and are managing it pretty well.

When you're referring to the government, it's the CDC
and FDA. In the case of S.C.A.N., it was initially a surveilance study not a diagnostic and was under
different requirements than a diagnotistic program.
CDC faulty reagents in their test kits made the situation worse. Obviously in the case of S.C.A.N
less government would of been better. Streamlining
instead of existing regulation.

yes, I agree govt public health actions can involve CDC and/or FDA. I wouldn't simplify the missed opportunities of the SCAN scenario as "less government would have been better". More like more government cooperation with local health authorities and more government awareness of the impending pandemic would have been better. The flu study folks in Seattle tried every which way to convince the feds-through multiple offices- that there was a local coronavirus outbreak and they had created testing tools to map and contact trace it. The feds were not interested in responding to either. The president was saying it was a few cases and would go away. The CDC response at that time was coordinated and overseen by a 34 year old dog breeder with no public health training or experience. February, in general, was horror show from a governmental public health management perspective.

And to be broadly fair, the federal govt wasn't the only ones blowing it. There's plenty of blame to go around. My state's DOH didn't develop and implement a solid COVID management plan until last week, and it took firings and reassignments to get people who wanted to do it on board. 3 weeks ago their own headquarters had no security, health screening, mask requirements or social distancing-and these are the people at work to lead the local response.

Harrison did work for HHS during the Bush administration. He also was Director of Healthcare
at DCI Group. His overview of the pandemic response was transferred to career Air Force MD
Robert Kadlec end of February 2020. Dr Kadlec was Director of Biodefense for Homeland Security under
President Bush.

Trump's impeachment ran into February.
Dems needed to cut the political BS and allow the
government to focus on major issues.

(08-29-2020 02:47 PM)pono Wrote:  

(08-29-2020 09:55 AM)utxctrack Wrote:  We have to keep in mind that there was no test for this in the beginning. They had to develop a test first. Then, they needed to have enough antigens for the test and they needed enough laboratories to process the tests. None of those existed because there had never been a human infected with this. Had China not barred our doctors and scientists from coming in right away we would be further along.

China was secretive about the virus for about a month in December when they were more concerned about PR. By the end of December they switched course and realized it could become a pandemic, alerted WHO, and shared info on virus, by January nearby countries were developing rapid tests. First US cases were from Europe, not the Chinese strain, end of January/ early February. Health researchers in Seattle identified the virus and quickly developed a test but we're blocked by federal government from using it. How much of that was regulatory protocol and how much was administration approach to directing all coronavirus response to the market and profit making is unclear but some of both has been documented. Our health care response to the virus has as much to do with China as does Vietnam's or Sweden's or New Zealand's, all of whom got it before us and are managing it pretty well.

Okay, first of all the first case of this disease in the U.S. was in Seatle and was a man who came from Wuhan. The European strain came later, infected New York and spread further. It didn't help that Cuomo put covid positive patients in nursing homes with the most vulnerable and killed about 15,000 people. Secondly, in January, while Trump was shutting down travel from Wuhan to stem the spread of this disease, China and W.H.O. were assuring the world that there was no human to human spread of covid 19.

(08-29-2020 11:10 AM)utxctrack Wrote:  Of course. However, if the antegens didn't exist they didn't exist. There were only so many labs to even process and they did aquire more. Everyone can look back and complsiun it should have happened faster but the entire world was faced with the same exact issue. wasn't just the USA. To blame Trump for the same issue that every single country had at the same time is ridiculous.

Trump is totally to blame and should be held accountable for downplaying or dismissing the threat of COVID-19 in Jan/Feb, wasted months that could have been spent on gearing up federal responses, prepardness and actions. That is all on him, its why even today 63% of US gives him poor rating on addressing this crisis. He's the leader and he failed this country.

https://www.factcheck.org/2020/03/trumps...ronavirus/