This article explains why a N-Assay for the coronavirus is critically needed!
https://www.nbcnews.com/health/health-care/ma...g-n1156006
"Several versions of a test are in use in the U.S., including the one developed by the Centers for Disease Control and Prevention. The CDC has made its test available to qualified laboratories, but some private labs lack the equipment to run it, Birenbaum said."
This is likely in reference to the machines needed to do PCR. N-Assay would be cheap!
"In the past week, Quest and LabCorp — two of the country's biggest clinical testing providers — began rolling out their own commercial tests to doctors and medical providers. But results typically take three to four days from the time specimens are picked up, the companies said."
Three to four days?! Probably because they have to ship the sample to the lab with PCR machines and then get put queue to process along with all the other samples. I recall that PCR machines require a qualified technician to operate. N-Assay is a point of care test.
"The turnaround is usually far quicker for smaller private labs and academic labs, because the testing is conducted on site instead of shipped to a central facility. Several private labs said they would be able to produce results within four hours once they were cleared to begin testing.
Quick turnaround is critical to slowing the virus, as an infected person may expose others before getting results back."
Three to four hours if the equipment is available onsite. I wonder how this duration is impacted by volume of test requested. They would have to be able to scale up with the number of PCR machines, but keep in mind that these machines are $$$$$. I think time to result was measured in minutes for the N-Assay.
"So far, the FDA has received requests from 14 private labs for expedited authorization, and 10 of them have begun patient testing, according to a spokesperson for the FDA. Many more labs and diagnostic device companies haven't even gotten to the point of requesting authorization because they are still developing their tests and trying to meet the FDA's requirements, industry representatives and lab experts said.
"We are talking to them around the clock, and our door is open for any developers who want to have a test for use in the U.S.," FDA Commissioner Stephen Hahn said Saturday."
If well-funded labs are having this much difficulty with a receptive CDC, I wonder what chance our little Company has. At least there would be minimal development time since all the ingredients are available and its only a matter of configuring the N-Assay to detect antibodies of the coronavirus.
"The University of Vermont Medical Center hasn't developed a test in-house and doesn't have the equipment to run the CDC's test. So it is waiting for commercial manufacturers to develop a test that its lab can use, Wojewoda said. And getting the test isn't the end of the process. "When we get it into the lab, we need to make sure it works in our hands," she said, noting that the validation process could take another week to complete.
One of the diagnostic tests the FDA is reviewing is made by Thermo Fisher, a major testing manufacturer. It would cut processing time to four hours, said Ron O'Brien, a spokesman for the company. However, FDA approval could still take weeks, O'Brien said."
Public labs are under pressure waiting for the CDC to get their act together and are open to using tests developed by private companies. And even the test from Thermo Fisher cuts processing time to four hours -- PCR? And I wonder why he didn't use the words "provide results" instead of "cut processing time"? Makes me think additional time is needed for the result.
"We've had a lot of issues with payments not covering the cost of the tests," Birenbaum said. "For our labs, it's a big investment to gear up for this. We're going to need to know if it's at least going to cover costs."
A lot of the cost is the investment in the PCR machines! Reimbursements to the labs in the thousands? Remember that guy who paid $3,000.00 to get himself tested? The N-Assay would be in the hundreds!!
"An academic research institute in New Jersey spent weeks developing a test that it says will produce results within four hours. Hackensack Meridian Health said in a statement that the in-house test will drastically reduce its turnaround time, as it consults with the state Health Department and then sends results to a state lab, which can take one to two days."
That "four hours" again....
It's a no brainer!!! All we need is for the CDC to give us a shot, but it sounds like they are only considering fully developed kits , which requires money that the Company does not have. All its resources are tied up with the goal of commercial launch of N-Assay for a handful of bacteria mentioned in previous updates.
This situation makes me sick.
On the other hand, I listened to some expert on pandemics say that the coronavirus will eventually turn into another seasonal flu. I didn't know, but the flues that go around now were also pandemics when they first came about. The goal now is to make it so that not everyone gets sick all at once such that it overwhelms our healthcare system.
https://www.nbcnews.com/health/health-care/ma...g-n1156006
"Several versions of a test are in use in the U.S., including the one developed by the Centers for Disease Control and Prevention. The CDC has made its test available to qualified laboratories, but some private labs lack the equipment to run it, Birenbaum said."
This is likely in reference to the machines needed to do PCR. N-Assay would be cheap!
"In the past week, Quest and LabCorp — two of the country's biggest clinical testing providers — began rolling out their own commercial tests to doctors and medical providers. But results typically take three to four days from the time specimens are picked up, the companies said."
Three to four days?! Probably because they have to ship the sample to the lab with PCR machines and then get put queue to process along with all the other samples. I recall that PCR machines require a qualified technician to operate. N-Assay is a point of care test.
"The turnaround is usually far quicker for smaller private labs and academic labs, because the testing is conducted on site instead of shipped to a central facility. Several private labs said they would be able to produce results within four hours once they were cleared to begin testing.
Quick turnaround is critical to slowing the virus, as an infected person may expose others before getting results back."
Three to four hours if the equipment is available onsite. I wonder how this duration is impacted by volume of test requested. They would have to be able to scale up with the number of PCR machines, but keep in mind that these machines are $$$$$. I think time to result was measured in minutes for the N-Assay.
"So far, the FDA has received requests from 14 private labs for expedited authorization, and 10 of them have begun patient testing, according to a spokesperson for the FDA. Many more labs and diagnostic device companies haven't even gotten to the point of requesting authorization because they are still developing their tests and trying to meet the FDA's requirements, industry representatives and lab experts said.
"We are talking to them around the clock, and our door is open for any developers who want to have a test for use in the U.S.," FDA Commissioner Stephen Hahn said Saturday."
If well-funded labs are having this much difficulty with a receptive CDC, I wonder what chance our little Company has. At least there would be minimal development time since all the ingredients are available and its only a matter of configuring the N-Assay to detect antibodies of the coronavirus.
"The University of Vermont Medical Center hasn't developed a test in-house and doesn't have the equipment to run the CDC's test. So it is waiting for commercial manufacturers to develop a test that its lab can use, Wojewoda said. And getting the test isn't the end of the process. "When we get it into the lab, we need to make sure it works in our hands," she said, noting that the validation process could take another week to complete.
One of the diagnostic tests the FDA is reviewing is made by Thermo Fisher, a major testing manufacturer. It would cut processing time to four hours, said Ron O'Brien, a spokesman for the company. However, FDA approval could still take weeks, O'Brien said."
Public labs are under pressure waiting for the CDC to get their act together and are open to using tests developed by private companies. And even the test from Thermo Fisher cuts processing time to four hours -- PCR? And I wonder why he didn't use the words "provide results" instead of "cut processing time"? Makes me think additional time is needed for the result.
"We've had a lot of issues with payments not covering the cost of the tests," Birenbaum said. "For our labs, it's a big investment to gear up for this. We're going to need to know if it's at least going to cover costs."
A lot of the cost is the investment in the PCR machines! Reimbursements to the labs in the thousands? Remember that guy who paid $3,000.00 to get himself tested? The N-Assay would be in the hundreds!!
"An academic research institute in New Jersey spent weeks developing a test that it says will produce results within four hours. Hackensack Meridian Health said in a statement that the in-house test will drastically reduce its turnaround time, as it consults with the state Health Department and then sends results to a state lab, which can take one to two days."
That "four hours" again....
It's a no brainer!!! All we need is for the CDC to give us a shot, but it sounds like they are only considering fully developed kits , which requires money that the Company does not have. All its resources are tied up with the goal of commercial launch of N-Assay for a handful of bacteria mentioned in previous updates.
This situation makes me sick.
On the other hand, I listened to some expert on pandemics say that the coronavirus will eventually turn into another seasonal flu. I didn't know, but the flues that go around now were also pandemics when they first came about. The goal now is to make it so that not everyone gets sick all at once such that it overwhelms our healthcare system.
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