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Stanford made COVID-19 tests available for health care workers. Now, it's considering wider distribution

State officials say ability to conduct tens of thousands of daily tests is key to lifting social distancing orders

As the global scientific community races to create tests for COVID-19 and end the public-health shutdown, Stanford University is trying to speed up the production of a newly developed antibody test, which was made available to its health care workers last week.

Launched on April 6, the test produces results in two or three days, according to a news release from Stanford University School of Medicine. Stanford Health Care is able to test 500 samples per day and it is hoping to "scale up quickly."

Stanford is one of many institutions, academic and commercial, that are working to develop and scale up COVID-19 tests (the Food and Drug Administration has approved 34 emergency use authorizations for COVID-19 diagnostic tests as of Tuesday, according to the agency). Rutgers University on Tuesday received approval from the FDA for a COVID-19 test based on saliva. And Stanford last month developed its first COVID-19 test, which uses a technique called polymerase chain reaction (PCR) to multiply, amplify and analyze DNA samples extracted through nasal swabs (the virology lab has since doubled its testing capacity from 1,000 to 2,000 tests daily).

Commercial companies such as Abbott Laboratories and Cepheid also have developed PCR tests, for which they received FDA approval.

Stanford's newly unveiled serological test detects two types of antibody molecules: immunoglobulin M (IgM), which helps disable the virus and then vanishes from the bloodstream several weeks later, and immunoglobulin G (IgG), which develops later in the infection process and remains in the body for far longer, providing immunity. Unlike the PCR test, which measures whether someone has the virus, the antibody test also determines whether someone has had COVID-19 in the past.

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The serological test that Stanford is providing for its health care workers is different from the test that Stanford researchers administered to thousands of volunteers earlier this month at three sites in different parts of Santa Clara County. That study, which aims to gauge the prevalence of virus infections in the county, is led by Eran Bendavid, an associate professor of medicine at Stanford.

Bendavid said the tests that his project was using came from the Premier Biotech, a Minnesota-based drug testing company. The tests, he said, can return results very quickly.

"The upside of these is that they're very inexpensive and very easy to use and you get results within 15 minutes," Bendavid said. "The downside is that they are maybe somewhat less precise than the laboratory-based tests. For the purposes of what we have done — for trying to get a sense of prevalence of antibodies to coronavirus in our community — they are perfect."

Bendavid said the tests somewhat understate the number of cases, a factor that the team is adjusting for in the research project.

While rapid tests such as the one used in the Bendavid study are suitable for research projects, Stanford believes the new serological test developed by its own pathologists is accurate enough for clinical settings. Dr. Yvonne Maldonado, a Stanford professor of pediatric infectious diseases and health research and policy, said during the April 9 virtual town hall that she believes the negative predictive value of the Stanford test is between 95% and 99%.

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"If you get a negative test, you can be 95% to 99% certain that the test is accurate," Maldonado said.

The ability to ramp up accurate testing is widely seen as a necessary precondition for ending the economic shutdown and relaxing social-distancing orders. On Tuesday afternoon, California Gov. Gavin Newsom released a list of six critical indicators for getting out of the stay-at-home order. The first indicator is the "ability to monitor and protect our communities through testing, contact tracing, isolating and supporting those who are positive or exposed."

Dr. Mark Ghaly, the state's Health and Human Services secretary, expressed confidence on Tuesday that testing is ramping up and said the numbers are "encouraging." Though he said he doesn't have a specific target for how many tests should be available before the shelter-at-home order is lifted, Ghaly said that with serological tests now gaining approval, California will be able to test "tens of thousands" of people daily. He also said the state is planning to greatly expand the number of community testing sites, as well the range of people who can request tests.

"We are beginning to move beyond just having tests available for the sickest people within hospitals, for health care workers as well as front line workers … (we're) looking to open a number of sites across the state to have community testing, for those who may be early with their symptoms or may have been exposed to somebody who is either asymptomatic or tested positive," Ghaly said.

The state's COVID-19 Testing Task Force credits Stanford Medicine on its website for launching the first serology test invented in California. But even despite efforts by Stanford and others, testing remains a source of frustration in Santa Clara County, where a total of 15,529 patients have been tested for COVID-19 as of April 13, according to county data, with 1,666 testing positive. It still takes more than two days, on average, to get a result, according to the county.

Both locally and statewide, labs have reported huge backups of tests, though Newsom cited some progress on that front Tuesday, noting that the backlog of tests in California has dropped from 59,500 in the beginning of April to about 13,200 as of April 13. The state has conducted about 215,400 tests as of April 13, with 23,338 people testing positive, according to state data.

In addition to boosting the number of tests, researchers at Stanford are also trying to improve reliability. While commercial tests are being developed around the world, Dr. Thomas Montine, chair of the pathology department at Stanford, described existing tests in the news release as "uncertain and variable."

"We thought this was an urgent medical need, and the usual supply chains were unreliable, so we decided to build our own," Montine said.

According to Stanford Medicine, the university's team had been working on the test since March 22. The team, led by Dr. Scott Boyd, associate professor of pathology, validated the new test using samples from patients who tested positive for the virus through Stanford's initial test, which relies on DNA analysis, and plasma samples that were known to be negative because they were collected more than two years ago.

Montine said in the news release that the university has sufficient inventory to run tests for at least six months, though it is currently limited by a number of robots it has to process the test. He said Stanford aspires to ultimately "provide serological testing to as many people in Northern California as we can."

Lloyd Minor, dean of Stanford University School of Medicine, underscored the importance of the new serological test at the April 9 virtual town hall, calling it "very important in terms of looking at the prevalence of antibodies in the community."

"As we move toward thinking about how to come out of shelter-in-place, it will be very important to determine what proportion of the population has developed an antibody response to the virus," Minor said. "That doesn't necessarily mean that those who have antibodies will be immune, but the presence of the immune response is the first step toward evaluating when it's safe to have more social interaction."

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

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Stanford made COVID-19 tests available for health care workers. Now, it's considering wider distribution

State officials say ability to conduct tens of thousands of daily tests is key to lifting social distancing orders

by / Palo Alto Weekly

Uploaded: Wed, Apr 15, 2020, 9:00 am
Updated: Wed, Apr 15, 2020, 12:01 pm

As the global scientific community races to create tests for COVID-19 and end the public-health shutdown, Stanford University is trying to speed up the production of a newly developed antibody test, which was made available to its health care workers last week.

Launched on April 6, the test produces results in two or three days, according to a news release from Stanford University School of Medicine. Stanford Health Care is able to test 500 samples per day and it is hoping to "scale up quickly."

Stanford is one of many institutions, academic and commercial, that are working to develop and scale up COVID-19 tests (the Food and Drug Administration has approved 34 emergency use authorizations for COVID-19 diagnostic tests as of Tuesday, according to the agency). Rutgers University on Tuesday received approval from the FDA for a COVID-19 test based on saliva. And Stanford last month developed its first COVID-19 test, which uses a technique called polymerase chain reaction (PCR) to multiply, amplify and analyze DNA samples extracted through nasal swabs (the virology lab has since doubled its testing capacity from 1,000 to 2,000 tests daily).

Commercial companies such as Abbott Laboratories and Cepheid also have developed PCR tests, for which they received FDA approval.

Stanford's newly unveiled serological test detects two types of antibody molecules: immunoglobulin M (IgM), which helps disable the virus and then vanishes from the bloodstream several weeks later, and immunoglobulin G (IgG), which develops later in the infection process and remains in the body for far longer, providing immunity. Unlike the PCR test, which measures whether someone has the virus, the antibody test also determines whether someone has had COVID-19 in the past.

The serological test that Stanford is providing for its health care workers is different from the test that Stanford researchers administered to thousands of volunteers earlier this month at three sites in different parts of Santa Clara County. That study, which aims to gauge the prevalence of virus infections in the county, is led by Eran Bendavid, an associate professor of medicine at Stanford.

Bendavid said the tests that his project was using came from the Premier Biotech, a Minnesota-based drug testing company. The tests, he said, can return results very quickly.

"The upside of these is that they're very inexpensive and very easy to use and you get results within 15 minutes," Bendavid said. "The downside is that they are maybe somewhat less precise than the laboratory-based tests. For the purposes of what we have done — for trying to get a sense of prevalence of antibodies to coronavirus in our community — they are perfect."

Bendavid said the tests somewhat understate the number of cases, a factor that the team is adjusting for in the research project.

While rapid tests such as the one used in the Bendavid study are suitable for research projects, Stanford believes the new serological test developed by its own pathologists is accurate enough for clinical settings. Dr. Yvonne Maldonado, a Stanford professor of pediatric infectious diseases and health research and policy, said during the April 9 virtual town hall that she believes the negative predictive value of the Stanford test is between 95% and 99%.

"If you get a negative test, you can be 95% to 99% certain that the test is accurate," Maldonado said.

The ability to ramp up accurate testing is widely seen as a necessary precondition for ending the economic shutdown and relaxing social-distancing orders. On Tuesday afternoon, California Gov. Gavin Newsom released a list of six critical indicators for getting out of the stay-at-home order. The first indicator is the "ability to monitor and protect our communities through testing, contact tracing, isolating and supporting those who are positive or exposed."

Dr. Mark Ghaly, the state's Health and Human Services secretary, expressed confidence on Tuesday that testing is ramping up and said the numbers are "encouraging." Though he said he doesn't have a specific target for how many tests should be available before the shelter-at-home order is lifted, Ghaly said that with serological tests now gaining approval, California will be able to test "tens of thousands" of people daily. He also said the state is planning to greatly expand the number of community testing sites, as well the range of people who can request tests.

"We are beginning to move beyond just having tests available for the sickest people within hospitals, for health care workers as well as front line workers … (we're) looking to open a number of sites across the state to have community testing, for those who may be early with their symptoms or may have been exposed to somebody who is either asymptomatic or tested positive," Ghaly said.

The state's COVID-19 Testing Task Force credits Stanford Medicine on its website for launching the first serology test invented in California. But even despite efforts by Stanford and others, testing remains a source of frustration in Santa Clara County, where a total of 15,529 patients have been tested for COVID-19 as of April 13, according to county data, with 1,666 testing positive. It still takes more than two days, on average, to get a result, according to the county.

Both locally and statewide, labs have reported huge backups of tests, though Newsom cited some progress on that front Tuesday, noting that the backlog of tests in California has dropped from 59,500 in the beginning of April to about 13,200 as of April 13. The state has conducted about 215,400 tests as of April 13, with 23,338 people testing positive, according to state data.

In addition to boosting the number of tests, researchers at Stanford are also trying to improve reliability. While commercial tests are being developed around the world, Dr. Thomas Montine, chair of the pathology department at Stanford, described existing tests in the news release as "uncertain and variable."

"We thought this was an urgent medical need, and the usual supply chains were unreliable, so we decided to build our own," Montine said.

According to Stanford Medicine, the university's team had been working on the test since March 22. The team, led by Dr. Scott Boyd, associate professor of pathology, validated the new test using samples from patients who tested positive for the virus through Stanford's initial test, which relies on DNA analysis, and plasma samples that were known to be negative because they were collected more than two years ago.

Montine said in the news release that the university has sufficient inventory to run tests for at least six months, though it is currently limited by a number of robots it has to process the test. He said Stanford aspires to ultimately "provide serological testing to as many people in Northern California as we can."

Lloyd Minor, dean of Stanford University School of Medicine, underscored the importance of the new serological test at the April 9 virtual town hall, calling it "very important in terms of looking at the prevalence of antibodies in the community."

"As we move toward thinking about how to come out of shelter-in-place, it will be very important to determine what proportion of the population has developed an antibody response to the virus," Minor said. "That doesn't necessarily mean that those who have antibodies will be immune, but the presence of the immune response is the first step toward evaluating when it's safe to have more social interaction."

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

Comments

Art
Barron Park
on Apr 15, 2020 at 2:35 pm
Art , Barron Park
on Apr 15, 2020 at 2:35 pm
4 people like this

Making testing widely available is the first key factor; the second is insuring that the tests are accurate. If everyone is able to be tested and the test results are accurate, I could envisage much of normalcy returning to our lives, even going to my dentist's office: - my dentist could perform procedures only on patients who have negative Covid-19 tests. Those testing positive would have to go to hospitals, where higher level of infection control measures are in place. The advantage of the Stanford tests appears to be the low false negative results. Until now, it's been unclear how (in)accurate the tests have been. Many folks have been ending up in hospitals these past months with negative tests even when all signs point to COVID-19. Dr. Yvonne Maldonado is quoted as saying in the story that she "believes" the negative predictive value of the Stanford test is between 95% and 99%. But we need more than belief - we need Stanford to show some real data.


scjeff
another community
on Apr 15, 2020 at 3:03 pm
scjeff, another community
on Apr 15, 2020 at 3:03 pm
4 people like this

Response to Art:
The test in this article is an antibody test. Still an important piece to the puzzle but it won't do what you're proposing.


More Info
Greenmeadow
on Apr 15, 2020 at 6:55 pm
More Info, Greenmeadow
on Apr 15, 2020 at 6:55 pm
7 people like this

Please provide a link/website with information on how to participate in antibody tests. Does anyone have that?


Experimentalist
Charleston Meadows
on Apr 15, 2020 at 9:20 pm
Experimentalist, Charleston Meadows
on Apr 15, 2020 at 9:20 pm
7 people like this

Eran Bendavid endangered the lives of his student volunteers, and wasted our time so that he could play a hunch that a rapid test might work. Well, it looks like it hasn't:

"Bendavid said the tests somewhat understate the number of cases, a factor that the team is adjusting for in the research project."

The is poor experimental science. We have good, sensitive, ELISA based tests (not the tests that were administered). He could have tested a smaller population and gotten a more definitive answer on how many people were sick in Jan/Feb. But now it looks like we won't have any definitive answers at all, and we've wasted time and endangered the lives of our volunteers. Blah.


Bev
Another Palo Alto neighborhood
on Apr 15, 2020 at 9:59 pm
Bev, Another Palo Alto neighborhood
on Apr 15, 2020 at 9:59 pm
8 people like this

Thank you Stanford for all you do to help and heal our communities! Antibody tests for all! For all you testing haters, the main reason the healthcare community have done so few tests, even though labs have the materials and capability to do thousands more a day, is our our County Health Dept. put strict guidelines on who you could test and who you couldn’t. Our Public Government officials are the ones restricting testing to keep the death rates high.....wonder why?


Jen
Another Palo Alto neighborhood
on Apr 15, 2020 at 10:09 pm
Jen, Another Palo Alto neighborhood
on Apr 15, 2020 at 10:09 pm
6 people like this

It will be interesting to see shortly, how many people in the Bay Area had this and recovered without any symptoms.


WHO
another community
on Apr 15, 2020 at 10:14 pm
WHO, another community
on Apr 15, 2020 at 10:14 pm
2 people like this

So the Negative Predictive Value of 95%-99% tells us who has NOT been infected at a reasonably accurate rate. How about the Positive Predictive Value, as we are looking to find how many people HAVE been infected and have antibodies, and hopefully immunity. If "only" 95% PPV, and we find a 10% positive test rate, half of those could be false positives?


Sue
Another Palo Alto neighborhood
on Apr 15, 2020 at 10:18 pm
Sue, Another Palo Alto neighborhood
on Apr 15, 2020 at 10:18 pm
9 people like this

[Post removed.]


Obvious
Mountain View
on Apr 16, 2020 at 12:14 am
Obvious, Mountain View
on Apr 16, 2020 at 12:14 am
8 people like this

[Post removed.]


Joe
Another Palo Alto neighborhood
on Apr 16, 2020 at 10:54 am
Joe, Another Palo Alto neighborhood
on Apr 16, 2020 at 10:54 am
6 people like this

There are about 7.5M people in the greater San Francisco Bay area. Stanford’s current testing capacity is about 3,500 people a week. At that rate, it would take 535 months to test the Bay Area’s population just once.

This whole idea of “scaling up” is obviously key to providing massive testing, which the Governor has specified as one of the criteria for opening up the state.

The following is a quick look at how long it would take to test just Bay Area--

Tests
Daily Weeks
-------- -------
10,000 107
20,000 53
30,000 34
40,000 26
50,000 23

The article says that Stanford is using robots to run its tests. In order to scale up this testing of all of California (and the US), a large number of robots will have to be purchased and installed in new facilities, which will need to be acquired, either through sale/lease and then outfitted for testing.

All-in-all, this project would seem to soon be out of Stanford’s ability to handle.

Clearly, a lot of money and organizational expertise will be needed to get this testing performed.


Stacy
Another Palo Alto neighborhood
on Apr 16, 2020 at 11:16 am
Stacy, Another Palo Alto neighborhood
on Apr 16, 2020 at 11:16 am
2 people like this

Stanford isn’t the only ones with the antibody test. Harvard is also doing antibody testing and there are other companies mass producing antibody tests. Testing is NOT necessary to open the economy, doctors offices, dentists, retail etc. There is no science to the fact if you test positive you will or will not spread COVID. It is actually more likely as most positive people still spread it to their family BECAUSE of the stay at home order. The economy needs to open with required face covering and required hand sanitizer at front door.


someone
another community
on Apr 16, 2020 at 11:20 am
someone, another community
on Apr 16, 2020 at 11:20 am
2 people like this

There was a good article in WSJ about what is lacking in current medical education - doctors who can't even read simple statistical observations:
Web Link


American
Another Palo Alto neighborhood
on Apr 16, 2020 at 11:39 am
American, Another Palo Alto neighborhood
on Apr 16, 2020 at 11:39 am
3 people like this

[Post removed.]


AV
Mountain View
on Apr 16, 2020 at 11:50 am
AV, Mountain View
on Apr 16, 2020 at 11:50 am
Like this comment

The National Institute of Allergy and Infectious Diseases launched a clinical trial.

Web Link


Anon
Another Palo Alto neighborhood
on Apr 16, 2020 at 12:17 pm
Anon, Another Palo Alto neighborhood
on Apr 16, 2020 at 12:17 pm
3 people like this

The News-Corp-owned climate-science-denying WSJ article is behind a paywall. But, the lead-in gives you an idea: "Doctors should learn to fight pandemics, not injustice."

That should not be an either/or. I agree that doctors should learn statistics, and, how to fight pandemics. They should also feel free to fight injustice, which they generally do. A large number of doctors treat the rich and poor alike, and, I applaud them for that. Too bad the WSJ is so dedicated to the preservation of injustice that it can't see beyond that.


someone
another community
on Apr 16, 2020 at 12:50 pm
someone, another community
on Apr 16, 2020 at 12:50 pm
6 people like this

@Anon, If you look at the current medical school admission criteria, you will be surprised - SOMs want to mainly admit students who played Social Justice card during their undergraduate years. They want students who pad their resumes with Social Justice Warriors (SJW) activities. This is very sad. A physician should be quickly diagnosed and treat you - for that they need to admit the best and brightest. The new policies of medical school admissions discourage many of the best and brightest to even apply to medical schools. I'm not saying SJW is bad - it is actually needed. But that role should be given to social workers. Or, at least there should be a balance in the admission criteria for medical schools.


LAHS Parent
Los Altos
on Apr 16, 2020 at 1:08 pm
LAHS Parent, Los Altos
on Apr 16, 2020 at 1:08 pm
1 person likes this

Many of us participated in Dr. Bendavid's study and were told we'd be contacted if positive for antibodies within a week. As far as I know, no one has been contacted and it has been 2 weeks since the test. What is going on?


someone else
Barron Park
on Apr 16, 2020 at 4:18 pm
someone else, Barron Park
on Apr 16, 2020 at 4:18 pm
2 people like this

@someone People want doctors who look like them. Of course in the bay area, people want the best and brightest because that's how people perceive themselves ;) More seriously, diversity in admissions to medical school will lead to better public health outcomes: Web Link


Connie
another community
on Apr 16, 2020 at 7:24 pm
Connie, another community
on Apr 16, 2020 at 7:24 pm
1 person likes this

I took my Serology blood work test today. I had called my doctor and we talked about why. Then she asked, who pays for this, I said my insurance sent me a letter saying they will pay for anything required for covid19.

I checked and looks like at least 3 days for results. This serology test is a blood draw test. Not a swab in the mouth,,or pin prick of the finger. If you want one, call your doctor and request one while there is no lines. I was in and out in 10 minutes today.


Daniel Wood
another community
on Apr 17, 2020 at 7:49 pm
Daniel Wood, another community
on Apr 17, 2020 at 7:49 pm
Like this comment

I got my yearly cold in Dec. In early Feb when to Subway and cashier had sniffles. Two days later sore throat and thought "I never get two colds a year". Soon after came down with perhaps worst cold ever. Must have been very contagious. My wife doesn't catch my colds but caught this and it was also bad. Took many weeks to feel good again. Over 60 with some health issues.

Microsoft employee with excellent health care through PAMF. PAMF might have the antibody test in a few weeks. I certainly want to see if we did have this.


scientific critical thinking
Midtown
on Apr 18, 2020 at 12:31 pm
scientific critical thinking, Midtown
on Apr 18, 2020 at 12:31 pm
Like this comment

The title of the article states "COVID19 tests" but the content is about "antibody" tests. They are different, and for different purposes.
We need widespread COVID19 tests , which is not available.
This article is misleading in that respect.


Jay T
Old Palo Alto
on Apr 19, 2020 at 3:30 pm
Jay T, Old Palo Alto
on Apr 19, 2020 at 3:30 pm
Like this comment

Is the IgG they were looking for unique to Covid-19? Their conclusion that the actual number of infected population is 50-85 times higher than the positive test result is wildly inconsistent with the 11% positive rate from the existing method.
The individuals who received the tests are almost hand picked and yet the positive rate is only around 11%. If the actual infected rate is "2.5-4.2 percent" as they suggested, then the old test should yield at least 20-40%.


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