A new diagnostic test for the novel coronavirus will return results in just 45 minutes, four times faster than existing machines.

But the test, emergency use of which was cleared by the Food and Drug Administration Wednesday, will likely be used in only the most urgent situations: triaging patients who are already in the hospital or the emergency room, and testing health care workers who might be infected to see if they can return to work.

“We don’t believe this technology should be used, at least initially, in a doctor’s office,” said David Persing, chief medical officer of Cepheid, the company that developed the test. “This is not a test for the worried well.”

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Cepheid, of Silicon Valley, is a unit of Danaher, the Washington, D.C.-based medical conglomerate. The test will begin shipping by the end of the week.

The announcement comes amid a dire shortage of test kits across the United States, which has hampered federal and local government officials’ ability to track the spread of the coronavirus and the respiratory disease it causes, known as Covid-19. Regulators in recent weeks have approved a rash of new testing tools developed by hospitals and commercial laboratories. The federal government also announced Thursday it had orchestrated an airlift of 500,000 swabs and sample kits needed for the tests from an Italy-based diagnostics company.

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Cepheid’s test will only make a small dent in the number of diagnostic tests available for the coronavirus, known as SARS-CoV-2, or the disease it causes, Covid-19. Persing said that Cepheid will produce millions of tests over the next few months. For comparison, Thermo Fisher, another test manufacturer, has said it will be able to produce 5 million tests a week by April. LabCorp can currently conduct 20,000 tests a day, and is increasing capacity further.

But the Cepheid test plays a very different role. Other tests must be brought to a centralized lab, sometimes in a hospital but often in a geographically distant location or at a testing facility such as those owned by Quest Diagnostics and LabCorp. These other tests are run in batches, meaning that all the tests are run at once over a period of hours. That means getting a test result back can take a day — or several days.

Cepheid’s machines can run one test at a time, and can be based near an emergency room or operating room. That means doctors can get a needed result in just 45 minutes.

Nearly 5,000 Cepheid devices are already in use by hospitals and other health care providers across the country, the company said, and over 23,000 exist around the world. These devices range in capacity, Persing said, from small systems that can run two to four tests at a time to large ones that can run 80 tests using a robot arm. Most systems, he said, are somewhere in the middle, having four or 16 test modules.
Another advantage of the test is that it doesn’t require cotton swabs, which are running in short supply in some places. Doctors can use saline to aspirate fluid from the nose with a catheter instead. Still, Persing emphasized, this is not a system suited to drive-through testing efforts.

“It needs to be used very sparingly for patients who really need it and for health care workers who really need it,” Persing said.

In recent days, officials in New York, California, and other hard-hit states have urged health workers to conserve tests and the protective equipment required to administer them because they’re in short supply. In Los Angeles, city officials told doctors to test patients only if the result would dramatically alter the course of their care. The strategy is a dramatic departure from that employed by other developed nations that have been far more successful curbing the virus’ spread, like South Korea and Singapore.

“The testing is going very well,” Trump said during a White House briefing on Saturday, adding that the FDA had “moved mountains” to foster the development of new coronavirus test kits and drugs.

  • I don’t have information on breathlizer s because it belongs to forensic science but we are dealing with a transmission from droplets that is passed from breathing the virus in or a way of tran mitting it? If we can come up with a method to use a breathlizer or a way to breathe into a balloon and use the droplets to measure under a devise that can measure it. I think you can speed up the test results in seconds!

  • If China and other Countries have found a way to curb it a in home kit like a swab sample must be admintered or like Italy a blood test is a quick way but we are talking about is a viral infection. Have a breathlizer test been invented like for DUI they measure how much alcohol is in your system. This is a challenge to scientist can they measure and scan someone’s mouth to see if the test result is positive or negative by how a person breathes?

    • There’s nothing to detect in the breath. If you mean a sputum sample like from a cough, well the thing that’s being detected is the viral RNA itself. Which requires doing RT-PCR on the sample currently. No breathalyzer for this virus.

  • Solving the problem for the public’s hunger for testing should be made with the triage system. From digital use of setting up talking with a doctor or simply using the telephone to helpline from a nurse the phone number on the back of your insurance card you can get medical advice from a nurse if you have serious complications of the Coronavirus or mild symptoms. It’s important that thermometers are used to measure how high your fever is if it isn’t high and you’re not experiencing shortness of breath and coughing or even severe weakness from a fever then you might just have a minor cold or minor fever. How long you started having these symptoms is very important information to let the nurse know that you need testing. Going to a hospital emergency room maybe crowded as written in the article you may not have it and catch the virus from others or you may have infected those you live with. I think to solve this problem a in home testing kit should be invented and approved by the FDA or the spread will increase. Some insurance companies have a nurse come out to visit me, like United healthcare and give you a $50.00 dollar Visa CC for the visit. If insurance companies had this plan more people would welcome a nurse into their home. However, nurses are needed at hospitals to care for the critically ill but find a way to seek treatment by calling first and then see if you can get a nurse to visit you at home. The nurse should wear a ventilator and protective clothing to keep herself as well as you protected from transmission. If where you live have a shortage of nurses and you live with someone else stay away from them and go to a quarintine facility in your area. I added the last two sentences as my own facts to possibly keep the spread down to a minimum.

  • Why not allow antibody tests that only take 10 min and are readily available for $4 each? Something does make sense here.

    • What’s the point if you get a negative results? Does it mean you are ok? And what iteans if you have a positive result? You have the antibody, but does it mean you are not contagious to others? Need more study on the levels and type of antibodies to understand how to use these easier tests

    • Antibodies only from later in the course of infection. They *may* occur as soon as three days into infection, so ELISA tests like you desire may eventually be helpful…once they’re developed and approved. Only in the development pipeline right now.

    • Would really like to have the immunity test. Had a bad respiratory flu a month ago. Could I be volunteering somewhere to relieve healthcare or other workers of simple duties with patients or public that would limit their (health care) contact and risk of infection if I had immunity?

  • It is an overall conclusion of this Pandemic that the more we understand what other countries are doing to curb it’s transmission from person to person it prepared our country to do what they have done as solutions. The more the public is educated and social media and journalist create write ups like Stats people can gain confidence that agencies like the FDA, Vaccine Research, Testing Companies Professional Doctors and hospitals are working tirerelessly to solve this Pandemic. One of the most vital concern is to produce a vaccine which is safe for everyone. We must stand with confidence that we will make it through this Pandemic without taking a large death toll as China and other countries whose numbers exceed way beyond our fatalities. If we reach an unprecedent numbers in infections then stronger measures should be taken. The President and his advisors must seek information from the Medical and Health committees who are knowledgeable and Data that is reported in each State to make clear decisions on how to manage this problem and keep communication lines open to the public. This is my opinion Lester L Fung.

  • Vaccines need to go through phase 1, 2, and 3 testing AT LEAST before releasing a vaccine. That is 8 months minimum, before anyone looks at production

  • As the company Cepheid delivers test kits and found a new way to swab people because swabs are running and Italy making contribution with kits it helps hospitals during this time of year if it reaches heighted risk to the Citizens of each State. We must free up our hospitals with only the critically ill as stated by Stats. Read the news like Stats you may be experiencing anxiety to mimic a cold or flu that you don’t have. The main thing if you have minor or flu take over the counter remedies and throat lozenges. Stats

  • There was not a good reason provided as to why it should always be limited to hospitals.

  • would like to see information on concurrent validity of the various tests. with a small sample of 100 individuals that think they might have the virus getting 3 different tests. then see if all 3 tests agree with one another.

  • This is fantastic! Now it should be possible to test a random sample of persons so that we can see how big percentage are infected without symptoms. Maybe many countries have arrived at herd immunity already, just that so many have had a mild variety. We actually don’t know, and that is crazy when all it takes it testing a random sample.

    • Nope. Those would be serological (blood) tests which look for antibodies. This is strictly for health care facilities. They need to know quickly if a patient is infected or not. Otherwise, the patient takes up a bed waiting hours or days, and risks becoming infected if not already.

      Also, hospitals need to know if staff are infected (two prominent doctors in NYC are currently infected, one of which is losing the fight without access to Remdesivir).

      I fully expect an executive order on Remdesivir very quickly. The political pressure will be intense. HCQ doesn’t work, or at least not beyond a certain point.

    • Hi Adam (or anyone who may know),

      Interesting points. May I ask two questions please? Thanks in advance.

      Q1) re: “fully expect an executive order on Remdesivir very quickly”

      I’m guessing but are you talking about “during a national emergency would-be patent infringement becomes a legitimate unauthorized use”? Meaning an EO making Remdesivir available to all those it may help, ignoring its patent?

      (see ref note 1 below)

      Q2) re “limited to hospitals”

      Is it because Cepheid got its EUA (Emergency Use Authorization) today from the U.S. FDA (Food & Drug Administration) so the tests themselves may not be fully validated yet (accuracy not ensured)?

      Or is it merely because the machine is rather expensive, so wide use is not practical as only hospitals can afford them and they don’t tests like a ton of samples in parallel?

      Thanks!

      Ref Note 1
      I used to love to read patent stuff and still find this 2008 Patently O blog post still very informative and so timely.
      “Intellectual Property in a Public Health Crisis”
      “The reality is that in a pandemic situation, the patent rights covering important treatments will be ignored. Under TRIPS, during a national emergency would-be patent infringement becomes a legitimate unauthorized use. At some later point, the patent holder should receive payment based on “the economic value of the authorization.” In all likelihood, however, that ex-post payment will be a small fraction of the potential monopoly profits that could have been earned.”

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