Home Health US lab’s 15-minute coronavirus test used in China – but FDA hasn’t allowed it

US lab’s 15-minute coronavirus test used in China – but FDA hasn’t allowed it

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A North Carolina-based company says its 15-minute blood test is already being widely used by the Chinese CDC, helping officials there to diagnose more patients, faster. 

On Thursday, that company, BioMedomics, announced its ‘quick and easy’ test is ready and being used in South Korea, Japan, Italy and some countries in the Middle East. 

But the US Food and Drug Administration (FDA) has not approved the test under the emergency measure it announced Saturday. 

Efficient testing is critical to any hope of containing the coronavirus that's spread to more than 101,000 people worldwide (pictured) - but US regulators' own test has proven slow and in short supply, and have not cleared the way for a faster diagnostic, for unclear reasons

Efficient testing is critical to any hope of containing the coronavirus that's spread to more than 101,000 people worldwide (pictured) - but US regulators' own test has proven slow and in short supply, and have not cleared the way for a faster diagnostic, for unclear reasons

Efficient testing is critical to any hope of containing the coronavirus that’s spread to more than 101,000 people worldwide (pictured) – but US regulators’ own test has proven slow and in short supply, and have not cleared the way for a faster diagnostic, for unclear reasons

BioMedomics claims its test can screen for coronavirus in 15 minutes using a small drop of blood and a tiny device that can be carried into the field

BioMedomics claims its test can screen for coronavirus in 15 minutes using a small drop of blood and a tiny device that can be carried into the field

BioMedomics claims its test can screen for coronavirus in 15 minutes using a small drop of blood and a tiny device that can be carried into the field

Outrage over slow testing has spread across the US alongside the coronavirus as the number of cases has swelled beyond 200 nd 12 have died

Outrage over slow testing has spread across the US alongside the coronavirus as the number of cases has swelled beyond 200 nd 12 have died

Outrage over slow testing has spread across the US alongside the coronavirus as the number of cases has swelled beyond 200 nd 12 have died 

To clarify, the FDA gave broad approval to any companies, states or institutions for if they have ‘a certified clinical lab able to handle the high-intensity test…they may develop their own test and do not have to wait fo us to approve it to start using it in patients,’ said Secretary Azar. 

It’s not clear what the qualifications are for sure a lab. 

But BioMedonics apparently doesn’t have them – though it is trying to sway US officials.

‘We are in contact with the Centers for Disease Control and Prevention, and have approached the FDA to inquire about US market,’ CO Dr Frank Wang told WRAL TechWire. 

It would seem that the states, institutions and companies that can now start testing people for coronavirus thanks to the CDC’s expansion efforts use diagnostic tools that are akin to the agency’s own. 

These are called ‘real-time reverse transcriptase-polymerase chain reaction (RT-PCR) tests. 

Performing this test requires taking throat and nasal swabs from patients – a rather unpleasant, uncomfortable process for patient and health care worker alike – and testing those samples for reactions that indicate they contain the genetic material of COVID-19. 

Swabs might be gross, but they’re the simplest part of the process.  

These types of test are considered the gold-standard for diagnosing infections diseases, but they involve multiple components, which are notoriously complex, they have to be run by specially trained technicians, using specialized equipments. 

According to BioCompare – a buying guide for life scientists – the ‘slightest DNA contamination can disrupt results’ from RT-PCR tests (though this is in reference to this general type of test, the diagnostic for COVID-19 in particular). 

The BioMedonics test – called COVID-19 IgM/IgG Rapid Test – is a blood test.   

A blood sample is collected, inserted into the reader, a buffer is combined, and results come back within 15 minutes, the company claims

A blood sample is collected, inserted into the reader, a buffer is combined, and results come back within 15 minutes, the company claims

A blood sample is collected, inserted into the reader, a buffer is combined, and results come back within 15 minutes, the company claims 

It can be read similarly to a pregnancy test, with one line for a negative test, two signifying it's positive for either early or late antibodies, and three when the sample is positive for both

It can be read similarly to a pregnancy test, with one line for a negative test, two signifying it's positive for either early or late antibodies, and three when the sample is positive for both

It can be read similarly to a pregnancy test, with one line for a negative test, two signifying it’s positive for either early or late antibodies, and three when the sample is positive for both 

It purports to be able to detect the virus within minutes, using either an IV blood sample or a droplet retrieved via finger-prick – even in patients that don’t have symptoms. 

The CDC itself previously cautioned that it’s possible for patients to develop COVID-19 after testing negative – although it’s unclear if this issue might have been resolved after the new reagent was made. 

After the sample of blood is collected, a technician injects it into the analysis device – which is about the size of an Apple TV or Roku remote – along with some buffer, and waits 15 minutes. 

Results are displayed in a similar fashion to those of an at-home pregnancy test. 

One line means negative. 

Two lines in a spread-out configuration means the sample contains antibodies that the body starts making shortly after infection. 

Two lines closer together mean the person is positive for the later-stage antibodies. 

Three lines mean the patient is positive for both types of antibodies. 

The blood test (right) is fast, but it's not as well tested as the gold standard used by CDC (right)

The blood test (right) is fast, but it's not as well tested as the gold standard used by CDC (right)

The blood test (right) is fast, but it’s not as well tested as the gold standard used by CDC (right)

However, the test hasn’t been as widely studied as have others. The company’s website cites a study of just 525 suspected patients. 

Of those, the test correctly identified 352 patients as positive, making it about 89 percent sensitive, or accurate. Twelve were false positives. 

So it may not be as precise as the gold standard, but it is certainly faster. 

‘Because there is no medicine or vaccine, the best way to combat this infection is isolation. A lot of people don’t have symptoms. Because of that, quick diagnostics are very important,” Wang said. “You can identify infection and isolate people,’ said Dr Wang. 

The CDC and FDA have not specified why the rapid test isn’t being used and did not respond to request for comment at the time of publication.  

WHAT IS TAKING THE US SO LONG TO TEST PATIENTS FOR CORONAVIRUS? 

Within days of shipping its tests, several states reported that the CDC’s diagnostic was returning ‘inconclusive’ results. The agency was forced to re-make one of the test components are reissue kits.  

Even since the CDC started to address this issue, delays have continued.   

US officials previously promised a million tests could be run by the end of this week, but Health and Human Services Secretary Alex Azar admitted ‘we currently have capacity to send tests for 15,000 people’ on Thursday. 

Vice President Pence reiterated the woe of US doctors Thursday, but said that the the US has tested the patients it absolutely needs to. 

‘We don’t have enough tests today to meet what we anticipate will be the demand going forward,’ he admitted after a meeting with 3M, which is expected to help ramp up mask production. 

‘For those that we believe have been exposed, for those who are showing symptoms, we’ve been able to provide the testing.   

CDC has had a series of delays in getting its tests out, and regulations for how it ensures the accuracy of other tests means that it could be another two weeks before the results of outside lab's tests are confirmed

CDC has had a series of delays in getting its tests out, and regulations for how it ensures the accuracy of other tests means that it could be another two weeks before the results of outside lab's tests are confirmed

CDC has had a series of delays in getting its tests out, and regulations for how it ensures the accuracy of other tests means that it could be another two weeks before the results of outside lab’s tests are confirmed 

The US coronavirus task force promised Monday that, by the end of the week, about a million coronavirus tests would be available. 

Now, it’s clear that goal won’t be nearly met.  

Secretary Azar explained Thursday the three steps that stand in the way to broader, faster testing. 

He said that even when the Centers for Disease Control and Prevention (CDC) itself developed a test, it had to get approval from the Food and Drug Administration (FDA) before distributing it. 

That request was submitted February 3 and approved February 4. 

The CDC didn’t start shipping its first batch of tests until February 6. 

Shortly after those tests arrived to labs, it was discovered a reagent was flawed, forcing the CDC to reissue the test. 

Right now, doctors have to call in to one of just over 70 labs in the US, describe the patient they suspect may have coronavirus, get approval for a test to be sent to them, then test the patient, and send the kit back to one of those 70 labs. 

On Saturday, the FDA gave approval for other states, companies and research institutions to make their own coronavirus tests to expedite increase the number of people who can be tested.  

CDC’s own manufacturer, IDT, is ramping up production, and Azar thinks that they’ll distribute enough kits to test about 75,000 people for the virus. 

With the addition of outside tests, Azar estimated that enough tests will be sent out to screen about 400,000 people – because two of the nearly one million tests to be shipped have to be used to test each patient under current guidelines. 

He thinks that will happen by the end of the weekend. 

But even then, it could be ‘a week, a week-and-a-half, two weeks’ before they are ‘up and running.’ 

Data to allow the CDC to ‘validate’ the tests has to be sent within 15 days of when these labs started administering them.  

So far, University of Washington scientists have begun using their own test, and is running samples 24-hours a day. 

They believe they’ll soon be processing some 1,000 samples each day. 

New York state – where at least 22 people now have coronavirus – as well as partner labs at Northwell Health and Stonybrook are now working on their own test, as well. New York was the first state to get authorization to start distributing its test.  

Meanwhile, Texas Governor Greg Abbott has quickly created an entire public testing lab network across the US to help the state – where so far four positive tests have been confirmed – to help expedite the process. 

He said so far half of the labs spread across 10 US cities are functional and ready to begin testing. 

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