Saffer - read this article as unfortunately this Cepheid test is
by no means a game changer in testing. Test would take 45
minutes to an hour (not 5 minutes) and the machine costs $25,000.
Thus they can process 1 test an hour and they do not
recommend usage in a doctor's office.
However, I'm hearing of a Game Changer test that was submitted
to the FDA for fast approval via the BARDA exemption from Da An
Gene Co Ltd and involves a simple pin prick of one's finger and can
be done at your home. Hearing of huge orders in the que for
this test all around the world. It does not require a machine
to process and provide immediate results.
BMRA ran big last week on test kits but is also mostly fluff -
these companies cannot deliver what is needed. Millions of
tests are what is needed.
Steve - I have lived in the medical lab world for over 30 years,
now technology is also changing and so I stay humble. A pin
prick at home sounds great but there have been tests out there that
have tried this method and failed. I would have to see how
you can reproduce good results with it. Have to run
linearity studies against a reference lab. The Gold standard
for any virus that first attacks your nasal passageways ( Covid-19
is transmitted via droplets in the air?) , so the mucus in
your nasal/pharyngeal area is going to have the presence of the
virus first. Once it is in your bloodstream you would have a
significant viral load (via finger stick).
The Cepheid is PCR technology that takes the nasal swab and
amplifies the virus a billion times in minutes. Also the CDC
is saying you must also test the patient for Flu A/B and RSV.
The Cepheid can test for Flu A/B, Strep A and RSV with one
nasal swab. So at point of care you can test a patient for
all of these and make a clinical definitive diagnosis. What
is your kid tests neg for Covid-19 but has RSV? you wont know
it if you are only testing for one thing. MD's can have
these analyzers in their office, and have trained staff to run the
test. The MD also will get reimbursed for the tests so it adds an
additional revenue stream. Majority of MD's do not outright
purchase the analyzer, they lease them and make a nice profit with
the reimbursements ( I have friends that runs these already).
The Cepheid analyzer you can add many additional cells
too if your volume picks up. This will reduce the burden on
Hospitals. The finger stick home test sounds good in theory
but not sure the over all effectiveness.
Also the Thermofisher test (FDA approved and announced last
week) requires a machine (expensive) that can process 98 test every
4 hours - much better than Cepheid but still not what is needed.
I'm in touch with one of the labs that will be processing the
tests and that is the reality.
Steve - I distribute all of them. TMO, Cepheid, Roche,
Abbott, Siemens, etc...the great thing is that all of the
manufacturers of lab analyzers will be able to offer solutions.
saffer - yes it's a step forward but more are needed. DHR
should catch a nice bid in this type of market. Send me you email
address via private inbox here on the blog. Simply click on
the envelope below one of my posts.
That is a standard lateral flow test. 99% of lateral flow
tests, if you get a negative result and the patient is
"symptomatic" you have to send out to a reference lab for
confirmation (typically takes 3 days to get that confirmation
results back). That test in not Molecular technology.
It is good for a first line of testing but the accuracy of
lateral flow tests for example with Flu A/B is only 50%.
Molecular technology actually incubates the samples strips
the RNA and amplifies it to get an early detection of the
virus, There is a difference in testing
methodologies.
TMO deals with large hospital labs. The make analyzers for
large facilities. Cepheid's main target is small-moderate
private office. Different targets.
Give me your email address and I will send video on the test -
it's in front of the FDA now. I cannot post here as I do not
have a video URL so simply send you email via a private inbox here
on the site.
Cepheid Test
Separately, the Food and Drug Administration announced on Saturday that ...
Posted by steve on 22nd of Mar 2020 at 10:16 am
https://www.statnews.com/2020/03/21/coronavirus-test-returns-results-in-45-minutes/
Saffer - read this article as unfortunately this Cepheid test is by no means a game changer in testing. Test would take 45 minutes to an hour (not 5 minutes) and the machine costs $25,000. Thus they can process 1 test an hour and they do not recommend usage in a doctor's office.
However, I'm hearing of a Game Changer test that was submitted to the FDA for fast approval via the BARDA exemption from Da An Gene Co Ltd and involves a simple pin prick of one's finger and can be done at your home. Hearing of huge orders in the que for this test all around the world. It does not require a machine to process and provide immediate results.
BMRA ran big last week on test kits but is also mostly fluff - these companies cannot deliver what is needed. Millions of tests are what is needed.
Steve - I have lived
Posted by ssaffer on 22nd of Mar 2020 at 11:27 am
Steve - I have lived in the medical lab world for over 30 years, now technology is also changing and so I stay humble. A pin prick at home sounds great but there have been tests out there that have tried this method and failed. I would have to see how you can reproduce good results with it. Have to run linearity studies against a reference lab. The Gold standard for any virus that first attacks your nasal passageways ( Covid-19 is transmitted via droplets in the air?) , so the mucus in your nasal/pharyngeal area is going to have the presence of the virus first. Once it is in your bloodstream you would have a significant viral load (via finger stick).
The Cepheid is PCR technology that takes the nasal swab and amplifies the virus a billion times in minutes. Also the CDC is saying you must also test the patient for Flu A/B and RSV. The Cepheid can test for Flu A/B, Strep A and RSV with one nasal swab. So at point of care you can test a patient for all of these and make a clinical definitive diagnosis. What is your kid tests neg for Covid-19 but has RSV? you wont know it if you are only testing for one thing. MD's can have these analyzers in their office, and have trained staff to run the test. The MD also will get reimbursed for the tests so it adds an additional revenue stream. Majority of MD's do not outright purchase the analyzer, they lease them and make a nice profit with the reimbursements ( I have friends that runs these already). The Cepheid analyzer you can add many additional cells too if your volume picks up. This will reduce the burden on Hospitals. The finger stick home test sounds good in theory but not sure the over all effectiveness.
Also the Thermofisher test (FDA
Posted by steve on 22nd of Mar 2020 at 11:35 am
Also the Thermofisher test (FDA approved and announced last week) requires a machine (expensive) that can process 98 test every 4 hours - much better than Cepheid but still not what is needed. I'm in touch with one of the labs that will be processing the tests and that is the reality.
Steve - I distribute all
Posted by ssaffer on 22nd of Mar 2020 at 11:40 am
Steve - I distribute all of them. TMO, Cepheid, Roche, Abbott, Siemens, etc...the great thing is that all of the manufacturers of lab analyzers will be able to offer solutions.
saffer - yes it's a
Posted by steve on 22nd of Mar 2020 at 11:46 am
saffer - yes it's a step forward but more are needed. DHR should catch a nice bid in this type of market. Send me you email address via private inbox here on the blog. Simply click on the envelope below one of my posts.
That is a standard lateral
Posted by ssaffer on 22nd of Mar 2020 at 11:58 am
That is a standard lateral flow test. 99% of lateral flow tests, if you get a negative result and the patient is "symptomatic" you have to send out to a reference lab for confirmation (typically takes 3 days to get that confirmation results back). That test in not Molecular technology. It is good for a first line of testing but the accuracy of lateral flow tests for example with Flu A/B is only 50%. Molecular technology actually incubates the samples strips the RNA and amplifies it to get an early detection of the virus, There is a difference in testing methodologies.
Yes good for a first
Posted by steve on 22nd of Mar 2020 at 12:01 pm
Yes good for a first line of testing instead of overwhelming the healthcare system. Thanks so very much for your input.
TMO deals with large hospital
Posted by ssaffer on 22nd of Mar 2020 at 11:37 am
TMO deals with large hospital labs. The make analyzers for large facilities. Cepheid's main target is small-moderate private office. Different targets.
Give me your email address
Posted by steve on 22nd of Mar 2020 at 11:29 am
Give me your email address and I will send video on the test - it's in front of the FDA now. I cannot post here as I do not have a video URL so simply send you email via a private inbox here on the site.
Cant you send it to
Posted by ssaffer on 22nd of Mar 2020 at 11:31 am
Cant you send it to my community inbox here? Thanks