Test... Test... Test




At first, what I am going to cover may seem like minutia. It may seem esoteric and overly particular, but it actually isn’t. Why? Because the distinction could mean the difference in staying healthy or even your life or death.

We have heard a lot about approved tests and treatments and vaccine development in the last 10 months surrounding the global pandemic. A lot of people get their information from social media, or conventional media in the form of networks or cable news outlets. Unfortunately, the individuals providing the information often use the term, “Approved” when talking about the latest tests or treatments. That word doesn’t actually apply. What they should be saying is that a test or treatment is “Authorized.”

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/

In other words, this is an emergency measure that allows application of an imperfect tool (test, treatment, etc.) because the potential risk of not using it is greater than potential errors resulting from its use.

Why does it matter?

According to FDA, test kits should aspire to a sensitivity and specificity rate of at least 99% before being approved. Accurate and reliable tests should have very low levels of false positives and false negatives (high “test specificity” and high “test sensitivity,” respectively), and are essential for generating results that can be used for making sound clinical decisions. So far no test is perfect, but according to the FDA tests should achieve at least 90% sensitivity and 95% specificity. Having no test is preferable to having a bad test, since bad results can lead to bad decisions made from a false sense of certainty. High test specificity (low false positives) is the more important of the two criteria, since a specificity even as high as 95% means that, for example, 50 individuals from a relatively small sampling of 1000 will be incorrectly identified as being or having been asymptomatically infected. That means individuals who do not look sick, who may not feel sick, but who are contagious may pose a risk to others.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#:~:text=Under%20section%20564%20of%20the%20Federal%20Food%2C%20Drug%2C,there%20are%20no%20adequate%2C%20approved%2C%20and%20available%20alternatives.




Authorized is not Approved

When you are approached about the use of a test or modality, it is wise to know the difference in the terms and to discuss those with your healthcare provider so that you can make the best choice. You may decide to use it, in fact you likely will, but you should also understand its reliability so that you don’t make faulty decisions about actions, gatherings, and potential exposure.

Additionally, each EUA carries particular information regarding the test’s use, its limitations, and particulars for use by a clinician. In some cases, it offers prescriptive language and qualifiers for physician and healthcare provider guidance such as:

…Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated…

That passage was an excerpt from an EUA summary. It recommends that caution be used and consideration of multiple factors in addition to the use of the test be applied. It states unequivocally that over reliance should be avoided. That is because, it is authorized under these unprecedented circumstances. It is not saying that the test cannot be used, or that is shouldn’t, but that if used understanding what the words mean really does matter

Here is where all of the EUA’s are listed:

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidppe

It is important to keep track of this as a consumer. It is also incredibly important to check often as status may change. Authorizations may be pulled as in the case of certain face masks.

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#nolongerauth

It is up to each person to double check the press, carefully consider a matter during a discussion with a practitioner, and know what the terms mean when forming a policy for a place of work, a social organization, or just a dinner party at home. The decision resides with each of us. We should just make sure we understand what the words actually mean.

Be well!

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