President Trump Orders Mass Production of Swabs for COVID-19 Test Kits – But is it enough? What about Re-agents?

On April 19, President Trump declared how he would use the DPA to increase the mass production of critically needed swabs needed for mass Coronavirus testing in America. The announcement came after repeated calls for action from state leaders. Locally, New York Governor Andrew Cuomo and Mayor Bill de Blasio have called upon the administration to help with their need for mass testing New Yorkers.

“We also are going to be using, and we’re preparing to use, the Defense Production Act to increase swab production in one U.S. facility by over 20 million additional swabs per month,” stated Mr. Trump. “We’ve had a little difficulty with one, so we’re going to call in — as we have in the past, as you know — we’re calling in the Defense Production Act, and we’ll be getting the swabs, very easily.  Swabs are easy.”

It’s not clear what company-(ies) would be actioned into service for this mass production of swabs. Recently, on April 16, the FDA (Food and Drug Administration) issued a press release: ‘Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs‘.

A portion of the FDA statement:

“”As part of this effort, U.S. Cotton, the largest manufacturer of cotton swabs and a subsidiary of Parkdale-Mills, developed a polyester-based Q-tip-type swab that is fully synthetic for compatibility with COVID-19 testing. Harnessing its large-scale U.S.-based manufacturing capabilities, U.S. Cotton plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing.””

Although, one report from CNN cites sources as stating that the company is Puritan Medical Product.

There’s this one related follow-up question the President received yesterday, “…On swabs.  But what about on the reagents?  They say that that’s something that they can’t get a hold of.”

The President:  “We have — we’re in great shape.  It’s so easy to get.  Reagents and swabs are so easy to get.  When you have to build a very expensive piece of machinery controlled by computers, that’s a different thing.  And, no, we’ll have — everything is going to be in very good shape, very soon.  We’re going to be in very good shape, very soon.”

It’s not clear exactly what the President had in mind in as far as Reagent production was concerned.

What are the test kit Components?

Swabs are merely one part of that which makes up a test kit. Components for the kit include the swab, the vial and the reagent. It’s a technical route which I myself am grappling with for lack of official sources to learn from, but we’ll get there. To help in understanding I’ll borrow quotes from our local leaders.

Mayor de Blasio on April 9, “…it turns out that, you know, the problem with the testing is you don’t just need the kits, you need the reagents. And I wish I could even tell you fully what a reagent was and there’s plastics involved in all sorts of things. I’ve heard the phrases, but what it adds up to is a lot of component parts to be able to mix the recipe together or as Jay was saying last night on the phone, if you want a cup of coffee with you know, cream and sugar, you need the coffee, the water, the cream, the sugar and the mug to put it in and we don’t have all those pieces, if you will when it comes to testing to get that cup of coffee with cream and sugar.”

More recently, “Putting together the full test kit takes three basic components, the nasal swab, the liquid solution – that’s what you keep the sample in, it’s called a viral transport medium – and a tube with a screw top that keeps the sample secure and sanitary. You need all three of those things to perform a test for the coronavirus.”

Governor Cuomo on April 18, “We have about 300 local labs in our state who have bought these 30 types of manufacturers and 30 types of tests. Then every time the lab goes to run that test, if I’m running the ACME test, I have to have the ACME equipment and the ACME vial and the the ACME swab and the ACME reagents. What are reagents? When you take the swab, nasal swab, throat swab, you then test it with other chemicals. The other chemicals are reagents. Depending on what test you bought, they have their own reagents for every test. The ACME test has one set of reagents. The Roesch test has another set of reagents and you have to go back to them to buy these reagents. That’s the basic chain. It gets very complicated very quickly because you have the national manufacturers who sold their machines to local labs. The local labs then need to go back to that manufacturer to run their tests. There’s very little uniformity among the tests. You’re trying to coordinate this whole private sector system. We have some public labs, the state has a Wadsworth Lab, but the real capacity is in these private labs.”

“Sometimes they talk about the equipment, nasal swab, vial. But what you see is most of them are talking about, we can’t get the reagents. We can’t get these other chemicals that we need to test. Where do they get the reagents from? Their manufacturer who made the machine in the first place, okay. And they all say with the machines we bought we could actually be doing more if they would give us the reagents. That’s the logjam that we are in. They bought the machine. They have the machine. They have the test but they need the reagents to do a higher volume of tests. When you go back to the manufacturer and say why don’t you distribute more reagents, they say one of two things. I can’t get more reagents because they come from China, they come from here, they come from here. We don’t make them in the United States. Or they say the federal government is telling me who to distribute to.”

More about the shortage of Reagents

An article put forth by Andy Heil of Radio Free Europe/Radio Liberty is titled, What’s A ‘Reagent’ And Why Is It Delaying Expanded Coronavirus Testing?

The writing starts off with the following:

Reagents.

“”It’s a fancy word for the main ingredients of any chemical-based test, which in this pandemic includes inorganic solutions as well as enzymes, probes, and primers created to match the coronavirus’s genome.

And they are a necessity for the coronavirus test kits that are vital to combating COVID-19, the pneumonia-like disease that by April 18 had killed more than 156,000 of its 2.2 million confirmed sufferers since the coronavirus jumped to humans in central China in November.

The importance of reagents will continue to outstrip supplies in many places as the race for safe and effective vaccines and treatment continue and governments embrace “testing, testing, testing” while they try to lead billions of people out of the great lockdown.

But for all their durability in a vial, the COVID-19 crisis has underscored our vulnerability to reagent shortages brought on by sudden demand, export bans, and stockpiling. Their scarcity is compounded by problems like limited production capacity and a market dominated by just a few firms.””

The article continues,

“”Suddenly All-Important

And by mid-January, China, the world’s leading maker and exporter of reagents and coronavirus test kits, was itself scrambling for diagnostic kits to screen for COVID-19 as the outbreak spread in Hubei Province and beyond.

Chinese demand and an export ban dried up global supplies and exacerbated a test-kit shortage that affected responses around the world to the mounting pandemic.

There was a knock-on effect in Europe, the coronavirus’s second “epicenter” by March, which quickly fell behind on demand for test kits. It still has not recovered, according to the head of the European Center for Disease Prevention and Control (ECDC), Andrea Ammon.

In the United States, the Centers for Disease Control and Prevention (CDC) blamed “one reagent that isn’t performing as it should consistently” when it hit a major snag rolling out test kits to states in February.””

Copyright (c) 2019. RFE/RL, Inc. Reprinted with the permission of Radio Free Europe/Radio Liberty, 1201 Connecticut Ave NW, Ste 400, Washington DC 20036.

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I’ll be continuing to followup on this subject, as will i continue to research and learn more and more. It’s clearly a subject which our leaders need to do a better job in educating the public about. Not that most individuals would have an interest in understanding. Yet, if explained in the best layman ways then folks would be able to better comprehend what they’re talking about and why there’s a need for testing and why it’s not being carried out. Just as with our Mayor’s analogy of making coffee there’s sure to be a better way of explaining all that’s involved and why things are going so slow.