FDA Q&A Regarding COVID-19 In-Vitro Diagnostic Tests (May 13, 2020)

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Introduction

On May 13, 2020, the FDA continued their Virtual Town Hall series to allow manufacturers and developers of COVID-19 tests the opportunity to ask questions to the FDA directly regarding the FDA Guidance on Emergency Use Authorization (EUA) and Policies on for In Vitro Diagnostic (IVD) Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency.

The FDA policy for diagnostic test kits for COVID-19 initially issued February 29, 2020 was updated again May 11, 2020, which supersedes the updates to the policy that were issued March 16, 2020 and May 4, 2020.

The FDA stated that since the May 4, 2020 policy update, they have updated some of the templates that they offer for manufacturers and industry stakeholders. They also stated that they are currently developing an at-home collection template.

The FDA also noted that they better outlined the validation required for antigen tests and that the first antigen test got authorization this past Friday (Quidel Corporation, Sofia 2 SARS Antigen FIA). There is high concern with false negatives for antigen tests and this concern is addressed in the updated policy and how to deal with any false negatives discovered during the validation process.

Additionally, the FDA announced that they will be hosting a virtual Town Hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency on Friday May 15, 2020 from 1-2 p.m. ET; 10-11 a.m. PT. The call details for this virtual Town Hall can be found here.  

Questions

The following are some of the questions that were asked during this Town Hall meeting and the subsequent answers. All questions and statements have been paraphrased. 

Is it acceptable for a controls manufacturer to label a SARS-CoV-2 assay without an EUA?
If specific claims are made about a control with a specific assay, then an EUA needs to be provided.

There was reference made about posting the NCI (National Institute of Health – National Cancer Institute) testing information but I could only find data for EUROIMMUN, how could I find all that data?
With EUROIMMUN an EUA decision was made based on the NCI data and so that’s why that particular set of data was posted. When other EUA decisions are made based on data, that data will be made public.

With serology clinical evaluations, for a finger stick sample, is it acceptable to compare finger stick results with previously obtained PCR (molecular) results or must the finger stick and the PCR test be performed concurrently?
The preference when comparing finger stick samples is to use other blood samples (whole blood, plasma, etc.) rather than a molecular pathway. This is due to the risk in using a previously acquired molecular test result which might not be correlated well enough to an antibody test dependent upon when the patient was tested positive and whether they developed antibodies or not. 

What governs the use of a nasopharyngeal (NP) swab as opposed to a nasal swab in testing?
The FDA feels that the NP is the better swab for specimen collection but have also authorized nasal anterior, nasal mid-turbinate, oropharyngeal, sputum, and bronchoalveolar lavage as acceptable specimen for various EUAs. A consideration of the swab choice also depends on the availability of swabs as there’s a shortage in NP swabs.

Is there a reference sample panel available for manufacturers to use?
FDA is working with BARDA (Biomedical Advanced Research and Development Authority) to make the sample panels or a subset of the sample panels available for manufacturers. The COVID-19 FAQ page also has information on the availability of samples.

What’s the difference between the umbrella EUA pathway for serology tests versus a separate EUA pathway?
For the umbrella EUA pathway, the test needs to meet the minimum threshold for specificity and sensitivity and the NCI needs to perform validation testing to verify the testing data that has been supplied by the sponsor. The NCI is doing lots of testing and once the test results from NCI are known, there is an expedited pathway to authorization. The FDA is looking for whether the testing generated between the sponsor and the NCI are consistent. The FDA will ask for data regarding a distinguishing test for IgG and IgM as NCI is not performing that testing. Cross-reactivity may be waived if specificity is 95% or greater.

Any updates on saliva testing? Could any sponsors looking at saliva testing use a bridging study rather than doing a full-blown validation study?
There were updates to the templates on Monday (May 11, 2020) which have recommendations for how to complete comparison testing. The templates also have content recommending how to validate saliva for testing. It should be noted that no sputum should be present in the saliva sample when testing it. Home collection of any sample type and home testing will need their own EUA.

Reimbursement information for antigen or serology testing?
Not within the FDA’s purview.

When do COVID-19 diagnostic tests require a prescription?
EUA are prescription only but who is able to prescribe is up to the states. This question is further addressed in the FAQ page under “General FAQs.”

Estimates of how long it takes to review validation results and to issue or decline an EUA request for serology tests?
This depends on what the FDA receives from the sponsor, if anything is problematic with the EUA submission, that will require more time to review. Some EUAs have been authorized anywhere from 24 hours to a week or two.

When importing serology tests undergoing an EUA review, will distribution agents need to be registered?
The distribution agent needs to be registered with the compassionate use code before the EUA and once the EUA is authorized, the EUA code can be used. If the product is imported, the importers need to be registered and listed.

If you are interested in future virtual town halls with the FDA, there will be one this Friday May 15, 2020 on 3D printed swabs and the diagnostic test town hall will continue next week on May 20, 2020.

How can UserWise help?

UserWise can assist you in swiftly obtaining Emergency Use Authorization (EUA) by providing appropriate Human Factors information to the FDA. We are experts at performing risk assessments, risk benefit analysis, and conducting user testing to confirm products can be used safely and effectively by the intended users.

We can help you obtain EUA, especially if you are pursuing an at-home test kit for COVID-19 that may require additional human factors data.

To help support manufacturers fighting COVID-19 as much as we can, we have created a knowledge base of free resources included below.

Free Resources

Watch a short video on how we can help you navigate the EUA process: https://userwiseconsulting.com/EUA-consulting

Book us for a free 1-hour consultation, EUA training, or Human Factors training by emailing us at userwise@userwiseconsulting.com.