Where are the tests? (opinion)


Where are the tests? It’s the question everyone is asking, as the nation scrambles to diagnose and contain Covid-19, also known as the novel coronavirus.
The limited supply of test kits has been the biggest challenge. There are only a relative few public health facilities — less than 100 at the moment, according to the Centers for Disease Control and Prevention — around the country that have been approved to perform the tests, including Northwell Health Labs, one of the nation’s largest hospital labs, where I work, on Long Island in New York.

Currently, we are testing about 200 patient samples in our lab each day, using US Food and Drug Administration-approved manual and semi-automated testing systems. This has been a significant upgrade from the solely-manual testing that had been provided by the CDC, which allowed us to test about 60 individuals a day.

Semi-automated testing lets a technician inoculate a specimen taken from the nostril of a patient into a cartridge, which is then placed in a console for automatic incubation and analysis (the cartridge is something like a 1970’s 8-track tape that snaps into the console like it’s an 8-track player). This enables a “batch diagnosis” of several specimens every two and a half hours. When we begin operating at full capacity, over 2,000 patients a day will be tested, but we aren’t quite there yet.

Northwell, for example, is working with GenMark Diagnostics, one of the first companies to get their semi-automated platform online and which received emergency use authorization from the FDA last week. But so are the other labs across the country, causing a major funnel block during a critical time.

We need to have patience.

With the limited supplies, health care providers have needed to prioritize testing the sickest patients. Of course, there are exceptions, and we have also prioritized for infection-control needs and for monitoring exposure — especially for patient populations within hospitals, nursing homes and assisted living facilities, and also for managing health care workers’ exposure to the virus.

As a country, we started late, but the full-court press is on to alleviate the effects of our delay. We’re not doing enough testing because there are not enough tests out there yet.

So where are they?

Each test kit that comes off the manufacturing line has to be quality checked before it hits the marketplace. You can only rush that process so much before risking manufacturing accuracy and testing efficacy.

With Covid-19, quite frankly, we were slow out of the gate. Initially the CDC and FDA announced that they were going to create all the test kits. Because of this, none of the other labs were able to start down the pathway to develop test kits.
Then the CDC had some missteps in supplying the state public health departments with test kits, and by the time the first patient died in Washington State, the CDC had only managed to distribute the test kits to about a dozen labs in a handful of states out of the 50.
At that point, when it became clear that the virus was spreading faster than the CDC could deploy test kits, the FDA turned around and opened up the authorization criteria so that other laboratories, like ours, could develop their own.

Who gets tested? Testing only the sickest people has caused some panic among people who think they may have Covid-19. It’s not feasible, at this point, for someone who has no symptoms but thinks they may have been in contact with an infected person to be tested. We need to focus on those who are presenting symptoms of the virus.

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Aside from hospitals, physician offices and urgent care centers are where the majority of tests are being administered at the moment. Northwell is also working with New York State, mobilizing the health system’s mobile phlebotomy team to perform nasal swabs in New Rochelle, which has been the epicenter of Covid-19 infection in New York. The initiative features a drive-through swabbing center where patients can go to have samples collected and tested.
In response to the testing shortage, President Donald Trump announced last Friday that the FDA is creating a 24-hour emergency hotline for laboratories finding impediments to running tests, and officials are giving nearly $1.3 million of federal money to two companies trying to develop rapid-diagnosis Covid-19 tests.

I applaud these efforts and any efforts we can make as a nation and as a health care system to fast-track testing, epidemiologic surveillance and care. My fellow colleagues across the nation’s health systems are doing everything and anything they can to speed accurate testing to the general public as soon as feasibly possible under our current circumstances.

Testing over the next couple of weeks is going to ramp up substantially, and you’re going to see a tenfold increase in the ability to do testing throughout the country. And in another couple of weeks after that, you’ll see a hundredfold increase.

Once we get there, then we will be meeting the demand. We’ll get to the point soon where we will be testing for this virus just the same way we would test for any other flu virus.

Source : Nbcnewyork