As of March 14 at 8:00 a.m., the state of North Carolina has a total of 680 public (i.e., non-commercial) coronavirus test kits.
So the big question is, “Why don’t we have more tests?”
Here’s the situation:
First, there’s a difference between “test kits” and “extraction kits.”
Extraction kits = extract RNA (genetic material) from nasal swabs.
Test kits = test RNA to see if it’s coronavirus.
We started with a national shortage of test kits. That happened because the CDC – after rejecting the WHO kits and deciding to make their own – had a manufacturing error that allowed their test kit to produce false positives. So they had to start over several weeks in.
To make matters worse, while the CDC was fixing their manufacturing error there were many other labs across the country (academic and commercial labs) that wanted to produce their own test kits. But they needed federal approval to move forward, and getting that approval took a couple weeks – a serious amount of time, given the prospect of exponential viral spread.
It appears we are now seeing the production of test kits ramp up from both the CDC and commercial labs like LabCorp (which happens to be headquartered here in North Carolina).
BUT that leads us to our second problem, and the current major bottleneck: extraction kits.
Before you can test the RNA sample from the nasal swab, you have to extract it. Doing so requires a specific chemical. The majority of this specific chemical (called a reagent) is produced by one company with production facilities in Germany and Spain.
And now that specific chemical is in very high demand. The whole world wants it.
A few weeks ago, the FDA started allowing independent labs to develop alternate chemical processes for RNA extraction. It’s unclear how much progress has been made.
So, looking now at the big picture, we basically have a two-track testing system: public testing, which involves our main state lab in NC using the re-manufactured CDC test kits (and in NC, we currently have 680 test kits) and then there’s commercial testing.
Regarding commercial testing, we really don’t know how much is happening. The commercial labs aren’t required to disclose test results unless they’re positive. In North Carolina, we have LabCorp conducting commercial tests. In Charlotte, we also have our two major hospital systems – Atrium and Novant – now saying that they are going to provide “screening.” It’s unclear whether they are simply collecting swabs and sending them to LabCorp (where they may face the same extraction kit bottleneck) or whether they’ve developed in-house capacity to actually produce their own test results.
But it’s important to note that BOTH public and commercial testing appear to be hitting a bottleneck when it comes to extraction.
As a result, we are not screening nearly enough people.
Ideally, anyone who displays flu-like symptoms would be eligible for a public test, free of charge. That’s how we would address this like South Korea and provide for wide-scale testing on the order of tens of thousands per day.
But – due to the shortage – that’s not the case. Instead, the CDC guidelines (which NC is currently following) currently state that you have to 1) display flu-like symptoms AND have had direct contact with a confirmed COVID-19 case OR, 2) you have to display flu-like symptoms AND lower respiratory symptoms (cough, shortness of breath) AND a negative flu test.
A simpler way to say that is we are currently rationing public tests because we don’t have enough capacity.
Congress is now providing more funding specifically for these issues and commercial labs are reportedly innovating rapidly, but this is essentially a race against time and increasing our testing capacity within the next ten days is absolutely critical. It’s also possible that the window of opportunity for containment – at least in some regions – is now closed and we’re going to have to rely heavily on social distancing to slow the rate of infection.
You should also know that in the process of piecing this together I had many, many conversations with state and local health officials and every single one of them was on the same page, knew exactly what the bottlenecks were, and were working the problem. These folks get it, and they’re working around the clock for us.
More updates soon,