FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 1

FDA Virtual Town Hall Series –

Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

Moderator: Talya Simpson

April 29, 2020

12:15 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants are on a 

listen-only mode. During the Q&A session, if you'd like to ask a question, you 

may press star, 1 on your phone. Today's call is being recorded. If you have any 

objections please disconnect at this time. I'd like to turn the call over to Ms. 

(Irene Aihie). You may begin.

(Irene Aihie): Thank you. Hello, this is (Ilene Aihie) of CDRH's Office of Communications 

and Education. Welcome to the FDA's sixth in a series of virtual town hall 

meetings to help technical questions about the development and validation of 

tests for SARS CoV-2 during the public health emergency. 

Today, Timothy Stenzel, Director of the Office of In Vitro Diagnostics and 

Radiologicial Health in the Office of Product Evaluation and Quality, and Sara 

Brenner, Associate Director for Medical Affairs, both from CDRH, who will 

provide a brief update. Following opening remarks we will open the line for 

your questions related to today's discussion. Now, I give you Timothy.

Timothy Stenzel: Hello, thanks for joining us again. I hope everybody's finding these town hall 

meetings productive. I look forward to another one today. We have many 

updates but it won't take me long, I think, to go through some of them. So we 

have many new EUAs authorized since last week. 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 2

We're recruiting four new serology authorizations. Please check our FDA EUA

Authorization web page. Also we've made numerous updates in the last few 

weeks for the frequently asked questions, including a new extraction option, so 

that hopefully is welcome news.

Finally, an important update, is they may have a new serology pathway,called

an umbrella, pathway for serology. This high level applies to serology tests that 

are submitted to the inter-agency test group. 

Currently testing is the (unintelligible) at NCI, and those are companies that 

submit a serology monthly a rapid test that (unintelligible) they're able to come 

through their pathway. Two, this program testing is performed currently at 

NCI, and then if performance metrics are met then those tests have a pathway to 

authorization under this umbrella pathway.

So I will speak a little bit to the specifics of this pathway. If it's not publicly

available yet it will shortly be publicly available . So, this is for - the devices 

that include in vitro diagnostics, SARS CoV-2 antibodies test, lateral flow or 

enzyme-linked immunosorbent assays, LFAs, lateral flow assays. That is a 

validation study performed at the NCI, or another government agency 

designated by the FDA and are confirmed by the FDA to meet the criteria set 

forth in the scope of this authorization letter.

Let me go through what those performance metrics are. All right, as performed 

by the NCI or another government agency designated by the FDA, using a well 

designed panel of at least 30 confirmed SARS CoV-2 antibodies positive, per 

each - and 30 per each immunoglobulin that tested (unintelligible) cracks, 

currently we're restricted with testing the IgM and IgG devices. 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 3

We'll say they're IG only or (PAN) or those thatIgM and IgG. And these are 

positive samples and then Ab antibody negative and/or pre-COVID-19 serum 

positive samples. Ten of negative samples must be confirmed to be HIV 

positive. 

The data must demonstrate a minimum overall 90% positive percent 

agreement, otherwise commonly thought of as sensitivity, in an overall 95% 

negative percent agreement or otherwise normally considered specificity, for 

the test to report specifically IgM and IgG results or has the ability to report a 

(PAN) result. 

A minimum of positive agreement for those tests that - test for and report out 

IgM and IgG as that for IgG there must be a minimum of 70% positive percent 

agreement with sensitivity of IgM and a minimum positive percent for IgG of 

90%. 

The data must also demonstrate no cross reactivity in the testing. So this 

program is now available to developers and they can protest by emailing us at 

the template's address. And with that I concluded my opening remarks and 

comments and unless Sara has something,I will open it up for questions. Thank 

you.

Sara Brenner: Thanks and this is Sara. I'll just remind folks that last week I discussed the lab 

data harmonization effort under a project called SHIELD at FDA in 

coordination with CDC and other federal partners. I believe there's a slide that 

is up or will be up on the WebEx providing that email address for more 

information: SHIELD-LabCodes@fda.hhs.gov.

Coordinator: The phone lines are now open for questions. If you would like to ask a question 

over the phone please press star, 1 and record your name. If you'd like to 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 4

withdraw your question press star, 2. One moment for the first question. There's 

a question in the queue from (Brant Lidger). Your line is now open.

(Brant Lidger): Hello Dr. Stenzel. Thank you for providing this opportunity. I think there was a 

question last week about a protocol for point of care testing with rapid 

diagnostic test kits, and the question had to do with whether you all wanted just 

demonstration with the ability to follow instructions, open the materials, follow 

the (unintelligible), a survey perhaps, or if it had to demonstrate the actual 

ability to get a true positive with a sample or a true negative. 

Could you expand a little on that? Since I think you also commented about 

demonstrating that the person doing it, say in this case a trained physician 

would be equal to a trained labratorian -- I think was the term that you used. I'm 

talking specifically now about the Rapid serology diagnostic test kits.

Timothy Stenzel: Yes. So, in general for a point of care type authorization, we will ask for 

lay-user studies. They're studies to demonstrate that a lay user can get accurate 

results when performed in that kind of setting onto those kind of conditions, 

with the kind of instructions that are provided with the test itself. 

And ideally those would check for accuracy of the ability of the lay users to 

perform that testing. This is a required part of any new device that we haven't 

seen before to perform - that we haven't previously authorized for a point of 

care setting, for the ability to be designated as such as a point of care device.

I would also like to add that we've been working hard on serology template and 

they are very close to being done and the expectation is that they will be out at 

latest the end of this week but maybe sooner.

(Brant Lidger): Okay, just one clarification. You talked about lay users. So what does that mean 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 5

in terms of a - say, a physician using it at point of care, outside of a CLIA

complex lab, say under a steady - say under a IRB? Is that appropriate to define 

point of care in that way?

Timothy Stenzel: So we have some broad language that covers near patient point of care and our 

FAQ page for point of care describes many of these. And I would have you 

refer to our frequently asked questions page for those environments. When we 

say lay user we are expecting that it is a healthcare professional of some sort, 

that it's - what we're demonstrating - what we're asking the developer to 

demonstrate is that a non-laboratory person, somebody that isn't trained in 

laboratory procedures maybe in a setting in a clinic where they don't normally 

perform tests as part of their all day long, every day activities, that, that kind of 

a user can get an accurate result with such a device. And two, it involves clear 

instructions, easy to do, easy to interpret, performance expectations.

(Brant Lidger): Thank you.

Timothy Stenzel: Next question.

Coordinator: Next question (William Chappa). Your line is open.

(Bill Chappa): Yes, this is (Bill Chappa) from a lab here in Grand Rapids. My question is kind 

of a general question. It deals with SARS CoV-2 PCR testing of asymptomatic 

individuals by nasopharyngeal collection in non-healthcare settings. Just 

wanted to see what the FDA's stance was on that, either a - for example, a 

workplace setting collection by a healthcare individual or the supervision of 

collection individual by a healthcare provider.

Timothy Stenzel: So, where would the test actually be performed?
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 6

(Bill Chappa): The test would actually be performed within a CLIA certified lab, just the 

collection process would be outside of there in asymptomatic individuals.

Timothy Stenzel: Okay. So as far as the collection by a healthcare professional, I'm not aware of 

any FDA regulations that stipulates when a healthcare professional is 

performing the swab. We obviously have authorized self collection but now not 

for nasopharyngeal swab. You specifically also asked about asymptomatic 

individuals.

(Bill Chappa): Yes.

Timothy Stenzel: Currently we have not authorized an EUA test that have claims for detection of 

SARS CoV-2 and molecular tests for asymptomatic individuals. If a 

manufacturer or a laboratory wishes to make a claim about the ability to 

accurately detect SARS CoV-2 in an asymptomatic population, that would 

require a submission for that specific claim and a study powered well enough to 

demonstrate the capability of detecting an asymptomatic person. 

And we don't exactly know what the asymptomatic carrier prevalence is out 

there, so how many people you might have to test in order to detect that. 

However, if you're asking can you use any given EUA authorized molecular 

test, like a nasopharyngeal swab, and perform testing on an asymptomatic 

patient. 

That is not something that we're going to say - best way to put it. This is - I think 

falls best under a currently listed frequently asked questions, where he had said 

that laboratories that received samples that aren't -- I forget the terminology. 

That aren't validated, they can receive those samples, perform the testing, but 

they can also amend the reports saying if they have - know that it's an 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 7

asymptomatic individual, saying that their test hasn't been validated for an 

asymptomatic patient and that a negative result does not mean they don't have 

SARS CoV-2. 

So, again, I think the important thing is, if a developer with a lab or a 

manufacturer wants to claim an asymptomatic sample type, that would require 

an EUA authorization.

(Bill Chappa): Perfect. Thank you for your time.

Coordinator: Again, if you would like to ask a question over the phone, please press star, 1 

and record your name, and also please limit yourself to one question. Thank 

you. Please go ahead. Your line is now open.

Man: Yes, good afternoon. I have one question about the umbrella pathway that you 

mentioned. The NCI is going to be performing those tests. Is - I believe you 

mentioned this but I want to make sure -- the best avenue to get information 

about getting in that umbrella pathway is through the template's email. Is that 

correct, Tim? And you mentioned having a website open or something of that 

nature, aside from the template? Is that correct? Thank you for....

Timothy Stenzel: Yes, sure. So, you can ask to be part of that program by emailing the template's 

address. You'll be connected to that program and you will receive information 

about ship to and the number of tests that would be shipped to the location. 

The umbrella pathway, is in the process, if it hasn't already been posted on the 

FDA website, is in the process of being posted. So, keep attention to the website 

to see all the details in this new pathway. And then the last question - what was 

the last part of that question?
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 8

Man: You got it actually. I asked if that was going to be a separate website or part of 

the - through the template, and I think you just explained it, that it will be noted 

on the FDA website. So thank you very much.

Timothy Stenzel: In addition there are more general serology templates that will be posted in the 

near future, hopefully by the end of the week but hopefully sooner than that.

Man: Great to hear. Thank you.

Coordinator: Next question's from (Sam Nelmy). Your line is now open.

(Sam Nelmy): Yes, I was wondering if you could share some perspective on the unintended 

consequences where pathway D manufacturers can sell easily in the US and 

have them administered by point of sale, (unintelligible) reputation, so when 

someone gets an EUA then suddenly they are required to be performed only in 

CLIA Labs. 

They are also subject to the restrictions of reporting back to the FDA who's 

using them false positives and false negatives so that the companies with an 

actual EUA end up having most of their products be bought by foreign 

governments who are willing to use unemployment care to utilize any kind of 

gold standard of (unintelligible).

Timothy Stenzel: Sir, hang on. I want to make sure I'm answering your question. So first of all, 

those who notify us via pathway D are only deemed to be used in the US in a 

high-complexity lab. They are not to be used moderate complex or in point of 

care or home use in any way. In order to get those - that authorization, they must 

come in for an EUA authorization. 

Also, in pathway D, those that have just notified us and have not been 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 9

authorized, they are formally not FDA authorized. And let's see, you had some 

other questions there I'm pretty sure. Oh, point of care. I just want comment on 

what it takes to be point of care. 

So, if they want to be moderately complex for point of care, they come in - they 

demonstrate the performance in those settings and we can deem those as point 

of care, and then they can be used as point of care setting. But those not 

authorized for those settings and those that haven't notified us cannot deem 

those for use for those purposes.

(Sam Nelmy): So, my understanding is there's no enforcement mechanismthen for pathway D. 

They can sell directly to point of care providers and they haven't necessarily 

covenanted that they're not going to. Whereas anyone with an EUA has -

(unintelligible) EUA specifically (unintelligible) that they're not going to be 

used inside of complex laboratories and that they're going to report back 

everything to the FDA. So the restrictions on the EUA tests make them less 

attractive in the local market in the practical sense than those with 

(unintelligible) EUA.

Timothy Stenzel: So those that have simply notified us that they have validated their test through 

pathway D, they are allowed under a high complexity lab certificate, if that lab 

sets up, say a draw on a patient, that lab is allowed to do, under their high 

complexity Clia certificate, under their rules, to do (quote) "Point of care 

testing". 

But if someone has simply notified us - a developer has notified us through 

pathway D, and they are selling into a point of care setting, that is not allowed, 

is not authorized. We have a fraud email on our FDA website, EUA website, 

you can send information about that and we will investigate and take action as 

appropriate. 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 10

And that said, email address is not easily available. You can always send 

something to our template email address. But if a developer is selling 

something into the point of care testing world, not under a high-complexity 

situation, they are not authorized to do that. We will investigate and we will 

take action as appropriate. Okay, next question.

Coordinator: Next question is from (Daniel). Your line is now open.

(Daniel: All right. Thanks Tim. I appreciate the weekly public information sharing 

session that you guys are doing. It's kind of a two-part question. Do you 

envision - what do you envision as the path forward indirect for (unintelligible) 

serology test kits. Currently it's only acceptable to use at high-complexity labs. 

Some developed countries have gone as far as making these available for home 

use, if I understand correctly. When do you see FDA policy changing to allow 

utilization of these tests at, at least point of care level? That concerns me from a 

commercial standpoint, in my opinion could reduce the (RNG) effort in 

development or investment activity for these test kits.

So that's part one. The part two is, we've seen so many unverifiable claims by 

suppliers of serological tests, companies claiming their (unintelligible) 

application or (unintelligible) distribution notification has been submitted or is 

in progress, (unintelligible) transparency, could FDA maybe consider 

publishing the status of developers that have (unintelligible)? Of course, we can 

see you approved one, but more, I guess related to in progress or that have been 

rejected, so that we know which manufacturers or suppliers to focus on or 

consider (unintelligible)?

Tim Stenzel: Okay, so the two questions are, I think, point of care, the need for that, and 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 11

status of submissions of serology tests. So, we do make the serology tests that 

have been authorized clear - that have notified us but haven't been authorized 

clear. 

We also have now made clear both the authorized and the notifications pathway 

what clinic or what clinical environment they can be tested in, whether it's high 

complexity or moderate complexity or point of care -- or what we call waved, 

with a W. 

So, H, M or W. It is more challenging to provide updates other than that 

because that is oftentimes considered proprietary, confidential information. If a 

test is denied, authorization, if under the NCI umbrella pathway, that I 

mentioned earlier, if you do not meet the performance bar, they will be removed 

from the (unintelligible) and potential other further actions may be taken. 

So those tests that may have been denied may be removed from the 

(unintelligible) list, and that will be out - that will be one way that we make this 

information public as soon as we make that decision. I hope that answered your 

question.

(Daniel): That did. And I guess maybe about the first part of the question, what the path 

forward may be.

Tim Stenzel: Yes. So, the pathway - if you come to us through our EUA template address, 

what the path forward may be. Yes, so the pathway, if you come to us through 

our EUA templates and ask what is required for a point-of-care validation, we 

will provide that to you. We are in the final stages of drafting the serology 

template, which will lay out these things a little bit more clearly for all to see, 

and will be posted publicly when they are signed off.
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 12

(Daniel): Okay, thanks.

Tim Stenzel: Our policy is that we will authorize point-of-care serology, and other 

point-of-care tests, if they meet the expectations in working with our reviewers

for those applications. So, there is no prohibition about this - there is also no 

prohibition about home collections or home testing. 

It's just that in the home collection, home testing situation, those require EUA

authorizations. They require specific accuracy tests to be done, so that we know 

in those environments accurate results can be obtained -- and the same goes for 

the point-of-care setting. So it is policy that we will authorize these if the 

correct studies are performed and the accuracy is there that we can authorize 

them.

(Daniel): Thank you sir. Thank you.

Coordinator: Next question is from (Erica Tyberski). Your line is now open.

(Erica Tyberski): Thank you. In regards to home testing of agnostic of type of, I guess, type of 

sample, what would be the gold standard you should be comparing against for 

performance characteristics?

Tim Stenzel: So, what kind of test are you developing, because it depends -- whether it's 

molecular, whether it's serology, or whether it's a direct antigen test.

(Erica Tyberski): I'm working with...

Tim Stenzel: So, sort of at a high level, the performance expectations are the same as if they 

would be performed in high-complexity lab. We require for point of care, a 

lay-user study, or for home use a consumer study that demonstrates that in the 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 13

context of those other environments accurate results can still be obtained.

(Erica Stenzel): Okay. Thank you.

Coordinator: Next question is from Sara. Your line is now open.

Tim Stenzel: Hi Sara.

Coordinator: Next question is from (Alberto Genier). Your line is now open.

(Alberto Genier): Hi, the question is, if the FDA consider any antibody (unintelligible). That's 

number one, and then in any of those pathways to get the EUA approved, is the

test needs to be performed any way with finger-stick or that is not being 

considered as part of point of care from home testing that would be - from my 

understanding, it would be done later?

Tim Stenzel: So two questions. One is Titer-based tests and the other is finger-stick tests?

(Alberto Genier): Yes.

Tim Stenzel: I believe we already authorized a lab - undeveloped test, a laboratory test in Mt. 

Sinai, that does the titer. We will consider authorization of the titer test. 

Obviously, that has different performance features that we want to make sure 

are accurate. 

So, engage with our reviewers on EUA template sites. Right now the templates 

that we're working on now will not specifically show what's suggested or 

recommended development tests should be for titer or (unintelligible) 

qualitative or quantitative serology tests. So anything other than a qualitative 

test, engage with our reviewers on what would be required for that.
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 14

On the finger-sticks, so the templates will lay out a recommended pathway for 

demonstration of performance accuracy with the finger-stick. It being 

compared to another sample type that’s been fully validated, like serum plasma 

or venipuncture whole blood.

(Alberto Genier): Okay, thank you.

Tim Stenzel: You're welcome.

Coordinator: Next question's from (Kay Jewel). Your line is now open.

(Kay Jewel): Hello. Thank you for all of this information. My question is about the umbrella 

pathway. In terms of what the cross-reactivity you're require - it's requiring a 

HIV. Will that replace - will they still have to also have do the cross-reactivity 

and the class specificity that's addressed in the March 16 policy?

Tim Stenzel: So the classic - or the other already open pathway for serological testing is still 

open. This new umbrella is a pathway that goes through NCI and other 

government agencies doing the testing from 30 positive and 80 negative 

samples. 10 of those negative samples will be HIV positive. And that's because 

there is some concern of potential cross-reactivity in HIV positive samples. 

So those are specifically added to look at that. We assess that if performance is 

good on the 80 negative samples, basically above about 98% no specific 

additional cross-activity testing may need to be performed with specific 

potential cross-reacting agents. 

However, if - in the usual pathways if performance falls below a level, we 

would ask for additional cross-reactivity testing to determine the reason why 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 15

specificity is lower than expected.

(Kay Jewel): Thank you. Thank you very much.

Coordinator: Next question's from (Mark Manuer). Your line is now open.

(Mark Manuer): Yes, these are terrific conferences, thank you. Wondering if you can detail 

some of the specifics regarding the serology tests, in particular potential 

cross-reactivities with other Coronavirus species or sort of what the threshold is 

there?

Tim Stenzel: Well, it's very minimum if any cross-reactivity is detected. It would have to be 

in the instructions reviews in the performance section. And if it reaches a 

certain level, a number of cross-reaction samples, that may be - that may impact 

a potential for a positive authorization. So, it's...

(Mark Manuer): I guess more simply put is, are the tests that are examined, are there panels of 

sera from other non-COVID-19 affected individuals that are not used in the 

screening process and as a parameter of either approval or not?

Tim Stenzel: There is not any sort of FDA panel, commercially available panel at this time, 

in hopes that, that could be happening. I've asked and I haven't checked whether 

our FAQ page lists potential providers of validation panels. For those providers 

of such panels, we have a process by which we engage firms, and if we feel it's 

something that we can make widely available to developers, as far as 

information goes, you can go to these providers, we will do that. 

We have had some providers approach us and I asked that they be reviewed and 

we can post one on the FAQs if we haven't already. We would post them. 

However we do know some providers, and if you email us at EUA template, we 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 16

can at least give you contact information. 

And if it's not on our FAQ page it would basically be information without any 

guarantee that - at this moment, that we've taken a look at them and we know 

that that's a good provider. 

But I know that there are providers out there that are developing these panels 

and as soon as possible we'll make as many of them as possible, (unintelligible) 

FAQ page, and if we get to the point where we can specifically recommend 

something we will do that. We understand that is challenging to get these 

materials.

(Mark Manuer): Perfect, thank you.

Coordinator: The next question is from (Ted Riff). Your line is now open.

(Ted Riff): Hi, yes, thank you. Good afternoon. My question is for Dr. Brenner if she is still 

available, or, Tim, if you could answer. At a town hall...

Tim Stenzel: She's probably better answering almost anything.

(Ted Riff): At a town hall two weeks ago it was mentioned that an FDA recommendation 

pertaining to 3-D printing of nasopharyngeal swabs. I was wondering whether 

we will be seeing that document soon or if it's still in progress? And specifically 

during this public health emergency, will FDA expect the hospital to register a 

list of (unintelligible) as a manufacturer if it prints the swab only for the internal 

hospital use of its own patients?

Tim Stenzel: Go ahead Sara.
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 17

Sara Brenner: So those are great questions and I know we have discussed the issue of 3-D 

printed nasopharyngeal swabs and other types of swabs on this town hall call 

for many weeks now, so I thank everyone for their patience. 

What I can share at this point is we most certainly are preparing formal

information or guidance. I don't want to be too prescriptive of what form it will 

take, but we are working on, what I believe the community will find to be very

informative based on the questions that have come in so far. 

And then there's a process that we go through internally to have that verbiage 

cleared, it will probably be out of our office this week and moving up through 

the necessary channels with posting hopefully as early as next week. 

I'm not making that promise but we certainly have been striving to get all of this 

information together and presented to the public as quickly as we can, because I 

know there are many, many questions and many people trying to address 

shortages through these very creative manufacturing means. So that's one thing 

I'll say.

The two other points on that. One is that we do intend to have an open 

discussion, a town hall- like forum, where folks who are interested in a dialogue 

with FDA and other federal partners can join in sort of an open-dialogue and 

those of you who have reached out by email following this town halls would 

certainly be welcome and any others would be welcome as well. So we're 

shooting to get that conversation set up and broadcast to the appropriate parties 

at some point next week. Again, thanks for your patience and stay tuned.

The last piece on this and related to that is our internal team, which includes 

subject matter experts, policy folks, regulatory experts, legal folks, the whole 

gamut, we've been following the literature closely, including data that has been 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 18

submitted to us for analysis and data that's been submitted to federal partners, 

including NIH and VA, too as, I believe most folks know we have an 

interagency partnership with -- on 3-D printing and additive manufacturing. 

And so there are many experts across FDA our agency partners who are trying 

to stay ahead of the curve with regards to what's being manufactured and 

advertised and marketed and used out in the field. 

So, in coordinating with those folks and stakeholders that have reached out to 

FDA and other parts of the government, we're looking for a sort of harmonized 

way that we can all work together safely and get products out there that are 

going to be effective and safe, and then also where that fits into our regulatory

framework given that these traditionally have been class 1 exempt devices.

To your question about registration enlisting, I'm not sure that we have a 

definitive answer on that yet, but it is something that will go into the guidance 

or information that we put out. We definitely are aware of that issue and that 

question.

(Ted Riff): Thank you for your answer and I really appreciate all the work you and 

everyone at FDA have been doing -- and for these town halls. Thank you so 

much.

Coordinator: Next question's from (Rita Coda). Your line is now open.

(Rita Coda): Hi Dr. Stenzel. Thank you so much for your time and answering all these 

questions. They've been really helpful. I just wanted to know, what is the FDA 

recommendation on recording quantitative results for serological tests, for IgG 

and IgM?
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 19

Tim Stenzel: Quantitative results for IgM and IgG. So, Tim, first of all. Thank you. This is a 

question that's for our expert review staff. I know that a - you know, a straight

sort of Titer has given determination that's pretty straightforward. But if you're 

going to do quantitative testing there's some additional considerations and 

development and performance evaluation of those, and I would defer to them. 

Our template's address is a perfect way to ask that question.

(Rita Coda): Okay, thank you.

Coordinator: Next question is from Sara. Your line is now open.

(Sara): Hi, good afternoon. Can you hear me?

Tim Stenzel: Yes.

(Sara): Hi, thank you for holding these town halls and describing this new umbrella 

policy. I've got a general question about pathway D and the serology test. Is that 

(unintelligible) considering that all of these tests will either need (EUA) in the 

future or some other FDA approval besides just the notification?

Tim Stenzel: So, that consideration is being thought about right now, and there may be 

something in the works in the near future to address that question. So, I would 

have to defer until that can - the deliberations are completed and we're able to 

make something public about that. We do understand the concern out there 

about at least some of these tests to pathway D.

(Sara): I completely understand. Thank you. So, just one quick follow-up. So are you 

suggesting then that once the serology test templates go out, then we can start 

preparing that EUA through the serology template?
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 20

Tim Stenzel: So, you can email still to the template email address and ask what is required for 

serology tests- today, now -- however, those templates will be made public in 

short order, and will provide much more clarification on our recommendation 

for validation of those tests.

(Sara) Wonderful. Thank you so much. I really appreciate it.

Coordinator: Next question is from (Tom Hahersh). Your line is now open.

(Tom Hahersh): Yes, thank you very much for your transparency on these weekly meetings. I 

appreciate it as I'm sure everybody else on the lines do also. I'm specifically 

addressing the serology testing and even more specific the lateral flow test. 

You've opened up the call with a very nice pathway forward for the validation 

for the EUA and submission guidelines for the lateral flow test as a device, but 

has there been any considerations of looking at digitizing those results through 

a device that may be agnostic to the vendor to pick up those lateral flow tests 

and enable epidemiological review of the data and other sorting of that data. 

Has there been any pathway forward for a device validation -- instrument 

device?

Tim Stenzel: Yes. So we're totally open to such devices. There are already such devices for 

other respiratory diseases on the market that allow the recording of 

non-identifiable information and uploading for public health surveillance type 

activities. So we're totally open to that and as long as the technology works, is 

accurate, then we'll authorize that. 

There's a number of different ways you can go about that. I would just state 

though that there could be considerations or concerns about things that are - can 

otherwise be visually read rather than, say, read by some other means, like 

fluorescence, that are - where the detectors are measuring something other than 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 21

a visual read, and its thing like lighting and how dark the bands are and things 

like that, and whether or not the device you're using to record the results is 

uniform in the marketplace. 

So, an application might be very valuable but if it's able to be used - able to 

utilize a number of different devices, smartphone, if the camera performance, 

for example, doesn't have resolution, the differential ways of handle the 

lighting, things like that. So our expert team would evaluate the technology that 

you're interested in developing and using in this way, to make sure that an 

accurate result is recorded by such a device.

(Tom Hahersh): Very good. Thank you very much.

Coordinator: Next question is from (Brad Fox). Your line is now open.

(Brad Fox): Hi there. Some of your information on the swabs have been answered but 

specifically I'm referring to the CDC recommendation for which type of swab 

should be used, the NP or NF swab and does the FDA have any thoughts or 

recommendations, especially as it might apply down the road for asymptomatic 

people, for instance, large organizations which will want to test people that are 

asymptomatic before their return to work, so differences between the two 

swabs. Is there an FDA preference, the CDC recommendations that they would 

prefer the NP over the NF, any thoughts on that?

Tim Stenzel: So first of all I would defer to - those kinds of recommendations, as far as what 

the CDC perceives is being important to the CDC. I think at the same time we 

all realize that performance, depending on the interval, a weekly NP swab on 

people who might be considering going back to work, other options are being 

considered out there for them, could be challenging from a number of 

standpoints. One of them is that NP swabs might not be readily available, the 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 22

supply issues. 

Second is, anybody who has had an NP swab will know - and I have as a 

volunteer - they are very uncomfortable and enduring that on a weekly basis 

could be challenging to people. So, this is an extremely challenging question. 

What is the - about testing asymptomatic people, and in certain situations like 

returning to work, this obviously is a very important question, and exactly how 

this should be done is still an unknown scientifically. 

Is there nasal swabs as effective as an NP swab? I think more data could be 

collected on that and we can see - I guess, from our standpoint, if a claim is 

going to be made, we want that claim to be supported by data for one type of 

swab or another. Exactly how labs utilize their tests for this situation is perhaps 

something that the FDA may not specify unless their making a claim. 

But we are working on a communication. It may just be an update to our FAQ 

page about this specific topic. So we'll be as transparent and forthcoming as we 

can, but we realize - and we hope that you realize that this is a very challenging 

topic.

(Brad Fox): Yes, and I really appreciate that. Some of the new tests that have come out on 

NF swabs and I was just curious if the FDA has been doing effectiveness testing 

between the two types of swabs or if that is something that will be done in the 

future?

Tim Stenzel: So there are some studies that have been done out there showing the differences 

between nasal swabs determinant and NP swabs, and then there are some 

developers who have done some of that work as well. Going forward as we 

know that there are now patients available to do these studies, comparisons 

between the different swab types sensitivities for detection would be important. 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 23

I think it's generally wise if you're going to do interior hairs that you swab both 

sides of the nose. 

But if you're going to do studies be sure that you properly randomize how you 

swab for say comparison testing different devices, different tests, different 

molecular tests, go forward potentially direct antigen test. And then if you also 

obtain another sample type like (unintelligible) or a nasopharyngeal, you also

take that into account as you randomize the sample collection. 

So you don't always take the nasopharyngeal swab first. You randomize 

whether you do that first versus another site, like (nares). So, I don't think we 

have definitive evidence yet about how much performance you might lose 

going from a nasopharyngeal to a (nares), even bilateral nares, even at a 

healthcare group study was pretty well done, but the numbers maybe could be 

added to with other studies. But it did show that there is a potential small drop 

off in sensitivities when you go from nasopharyngeal to (anterior) nasal swab.

(Brad Fox): Okay, thank you so much for - it is a challenging question. So thank you for 

your comments.

Tim Stenzel: You're welcome.

Coordinator: The last question we have time for today is from (Kevin Boykin). Your line is 

now open.

(Kevin Boykin): Hey, Tim, thanks for holding these calls. They have been very informative. I 

work for a specimen collection kidney company, focusing on getting supplies 

out to clinicians for the collection of these samples, and we're trying to address 

the shortage in media. I know you guys had some conversations around how 

you can address some of this on the FAQ page, but has there been any talks 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 24

around (unintelligible) in EAU or (unintelligible) page for additional media that 

could be used for the collection?

Tim Stenzel: I think we would be open to an EUA. We have been working with certain 

entities who have come forward to us on plans that they have to manufacture 

(VTM) and distribute it. So, some of them are copying these on CDC formula 

and they've come forward to us and we've worked with them on a plan to do that 

and allow them to do that. 

One of the important features of (VTM) is (unintelligible), whether it be (VTM) 

or say (unintelligible) important factor. We realize this is a great unmet need 

and we are thinking about what we might do to make (progress) on this. But for 

now you can simply send us an email to the template's email address and we 

will work with you one on one to address any concerns that we have about what 

you might want.

(Kevin Boykin): All right. Thank you, Tim.

Coordinator: And I'd like to turn the call back over to Ms. Irene Aihie.

Irene Aihie: Thank you. This is Irene Aihie and we appreciate your participation and 

thoughtful questions. Today's presentation and transcripts will be made 

available on the (CDRH) web page at www.fda.gov\training\cdrhlearn by 

Monday, May 4. 

If you have additional questions about today's presentation, please email 

cdrh-eua-templates@fda.hhs.gov. As always, we appreciate your feedback. 

Following the conclusion of today's presentation, please complete a short 

13-question survey about your FDA-CRH virtual town hall experience. The 

survey can be found at www.fda.gov\cdrhwebinar, immediately following the 
FDA

Moderator: Irene Aihie

4-29-2020/12:15 pm ET

Page 25

conclusion of today's live discussion. Again, thank you for participating. This 

concludes today's discussion.

Coordinator: This concludes today's call. Thank you for your participation. You may 

disconnect at this time. Speakers please standby.

END