The US has sufficient knowledge and capacity to re-open the economy now

Across the U.S., tens of thousands of similar academic research labs have the expertise and equipment to help the country test for Covid-19. If even one-tenth of these labs joined the effort, we could test an additional 500,000 to one million samples a day.

We Have a Coronavirus Test—Let Us Use It

By Jack W. Lipton and Caryl E. Sortwell, WSJ  4-15-20

Our research team used Food and Drug Administration guidelines and a scientific report from Wuhan, China, to develop a Covid-19 test in early March. It took one week. Our test doesn’t use the reagents other labs are desperately seeking, and it can identify levels of virus so low that a typical test could miss them entirely. Yet our lab sits idle.

Across the U.S., tens of thousands of similar academic research labs have the expertise and equipment to help the country test for Covid-19. If even one-tenth of these labs joined the effort, we could test an additional 500,000 to one million samples a day.

Academic research labs conduct studies; they don’t test patients. In fact, they’re legally precluded from offering a result that would inform a diagnosis. This makes sense—even with our advanced testing capabilities, highly trained scientists and cutting-edge methods, the regulations governing scientific research differ from those governing clinical diagnostics. Yet the mission of medicine is at the core of what we do, too. Our labs exist to improve the lives and alleviate the suffering of our fellow citizens. Let us help.

The Centers for Medicare & Medicaid Services manages the Clinical Laboratory Improvement Amendments certification system. The FDA approves high-complexity testing and regulates who can run a test and which tests can be run.

Although regulations have been relaxed to allow academic research laboratories already working under the umbrella of CLIA-certified labs to be “deputized” for coronavirus testing, in the 85 days since the first infected American citizen was identified, less than 1% of the population has been tested.

If the CMS and FDA would collaborate to allow states temporarily to deputize any academic research lab providing evidence of a working, FDA-compliant Covid-19 test, several thousand idle labs across the country could validate any number of approved Covid-19 tests. Screenings could be validated in less than a week.

Under normal circumstances, the rules that govern medical labs make sense. But when patient welfare is compromised by the lack of widespread testing, we need to adapt.

State and federal leaders should join us in urging the CMS and FDA to offer swift temporary CLIA accreditations for academic research labs that demonstrate their fitness to assist testing efforts. By clearing this path, these regulatory bodies will help all citizens have a better chance in the fight against Covid-19.

Mr. Lipton and Ms. Sortwell are, respectively, chair and associate chair of translational neuroscience at Michigan State University’s College of Human Medicine.

April 16, 2020 | 7 Comments » | 534 views

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  1. Forbes Study Ranks Israel As Safest Country Regarding Coronavirus Pandemic

    Israel was ranked as the safest country out of the 60 countries, followed by Germany, South Korea, Australia and China in fifth place. In first place for most dangerous country was Italy, followed by the USA, Britain, Spain and France in fifth place.

    Regarding level of efficiency of the closure, Israel scored a high grade for restricting movement, enforcing and supervising the closure, but received a lower grade on economic relief for citizens during the closure. Israel also scored a high grade on its governmental management of the pandemic as well as on technology used to locate and isolate coronavirus patients, but received a lower grade on the amount of tests conducted on the population. (A new saliva test was authorized Wednesday in Israel which will not require a swab or a paramedic).

  2. Michigan authors aren’t even MD’s nevermind epidemiologists or biologists. They are experimental neurologists from a pro Trump financially strapped state and impoveshed university with snake oil to sell. Their ‘lab’ has no prior experience with the FDA nor medical production testing. Their article appears at the bottom of page A13 which is the WSJ’s lazy opinion page devoted to industry hacks’ sophmoric writing because the Journal’s financial cutbacks cannot pay for legitimate material. It’s dreck.

  3. Dems governors are playing politics and want more damaged goods and blame Trump!
    In the EU, Belgium follows closely Spain!!! Not mentioned!!!!
    What happened to the US study on comparing treatment with and without the combo or trio with Zn?

  4. “The two professors[Jay Battacharya and Eran Bendavid, both medical doctors] argue that the best evidence of the coronavirus death rate being significantly lower than what is being reported may lie in the Italian town of Vò. On March 6, the town’s 3,300 residents were tested. Of these, 90 tests came back positive, indicating a prevalence of 2.7% of the population having the virus.

    If one were to apply this to the entire province where the town is located, which has a population of 955,000, it would mean there were actually 26,000 infections at the time, and not just the 198 that were officially confirmed. This would be 130 times greater than the number of reported cases. Since Italy’s case fatality rate of 8% is estimated using the confirmed cases, Bendavid and Bhattacharya write, “the real fatality rate [of the virus] could in fact be closer to 0.06%.”

    A ’cause for optimism’?

    The two Stanford Health Policy experts even said the virus’ mortality rate might be on par with that of the seasonal flu:

    Existing evidence suggests that the virus is highly transmissible and that the number of infections doubles roughly every three days. An epidemic seed on Jan. 1 implies that by March 9 about six million people in the U.S. would have been infected. As of March 23, according to the Centers for Disease Control and Prevention, there were 499 Covid-19 deaths in the U.S. If our surmise of six million cases is accurate, that’s a mortality rate of 0.01%, assuming a two week lag between infection and death. This is one-tenth of the flu mortality rate of 0.1%. Such a low death rate would be cause for optimism.” From the

  5. If Drs. Battacharya and Bendavid of Stamford University are correct that the number of infected individuals doubles approximately every three days, and had already reached six million as early as March 19, then allAmericans should have been infected by early April. That in turn would mean a death rate of about 1 in 13,000 infected people. Or les than .0001%.

    Of course, the drastic measures used to slow the rate of infection may have slowed its spread, and thereby reduced the number of people who have acquired immunity and/or herd immunity, to the disease.

  6. An ‘experiment” in the small Italian town of Vo, near the heart of Italy’s “pandemic,” may indicate that that widespread testing of “asymptomatic” people may help to safely restore normal life.

    “Andrea Crisanti, an infections expert at Imperial College London, who has been involved in the village’s efforts to combat the virus told Italy’s broadcast media that continuous testing and retesting of the whole population made the difference.

    Professor Crisanti said: “In Vo Euganeo we tested all the inhabitants, even those who were asymptomatic.

    “All citizens were put in isolation, so they could not transmit the disease.

    “On the second testing that was carried out, we recorded a 90% drop in the rate of positive cases. And of all the ones who were positive in the second testing, eight people were asymptomatic.

    Professor Crisanti warned that that for every patient that shows symptoms for COVID-19 there were about 10 who don’t.” From Sky News, March 20.

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