ID Now

Pet,

Per CAP, validation consists of accuracy, precision, and reportable range.  However, we are under an emergency situation, the validation does not need to be as extensive as any other time, as long as your lab director approves it.  Example, in my opinion, 5 negatives and 5 positives would be sufficient for the precision, rather than over 20 days. 

Keep in mind that each analyzer can only run 1 patient at a time.  So we have several little boxes on the counter to run strep and flu tests. So throughput would only be 4 patient/hour if you have mostly negatives, a few more if you have positives.  In my opinion it's not suitable for high volume, but great for STAT tests like pre-op.

Agree with Adonica's post. Although I'm kind of afraid to follow 'common sense' at this point with 'emergency use'. No offense meant to FDA folks.

I also agree with Chris that performing is very easy IF ONLY operators would take their time and not try to rush the steps. The little display is clear when to proceed to next step. We still have issues with folks thinking they can anticipate and have to start over.

The following is from the FDA's website:

FDA does not CLIA categorize tests authorized under EUA. Instead, the settings in which an EUA authorized test may be used are described in the Letter of Authorization. We note that the terms "patient care settings outside of the clinical laboratory environment," "near patient testing," and "point of care" in the EUAs, Policy for Diagnostic Tests for Coronavirus Disease-2019, and generally refer to settings that are equipped with the instrumentation and appropriately trained personnel necessary to perform the test, and may include settings such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.

From CMS mlnconnects special ed Tuesday 3/31/2020:

...CMS will also allow hospitals, laboratories, and other entities to perform tests for COVID-19 on people at home and in other community-based settings outside of the hospital. This will both increase access to testing and reduce risks of exposure. The new guidance allows health care systems, hospitals, and communities to set up testing sites exclusively for the purpose of identifying COVID-19-positive patients in a safe environment.

In addition, CMS will allow hospital emergency departments to test and screen patients for COVID-19 at drive-through and off-campus test sites.

I am confused is this test waived or highly complex?

Dan,

Thanks.  That is what I thought. Since it was approved under EUA the required number for precision, comparison  and accuracy will not be the same.  The test is not cheap in itself.  It is interesting that since it was shown in the President briefing, Facebook was loaded with people expecting tests to be quick and no one should be turned away anymore.

With Lab week coming up and many CLS,MLS, MT, MLT are posting that the test is not "plug and play" that there are people behind these testing.  I think the public needs to know this.  Results are not instant.  A positive with the Abbott ID now is 5 minutes but negative still takes 15 minutes.

This is moderately complex per the FDA through the EUA ruling.  It's interesting how WA has a waived status, I did not think the FDA would make a ruling like that on a state by state basis.

I am hesitant to put it in any of my waived sites. Having to implement a totally new instrument and make the staff work with a potential COVID + sample would necessitate some intensive training. I do not want to rush this thing out to our sites and then get burned afterwards.

I have heard from another organization that they are also worried since the performance of the tests are not that great.

Since this test is approved under EUA, there is NO categorization, meaning it is neither waived, moderately complex or highly complex.  As long as you follow the instructions-for-use and have the right personnel trained, anyone can do it.  Below is what I found from the FDA's website. 

FDA does not CLIA categorize tests authorized under EUA. Instead, the settings in which an EUA authorized test may be used are described in the Letter of Authorization. We note that the terms "patient care settings outside of the clinical laboratory environment," "near patient testing," and "point of care" in the EUAs, Policy for Diagnostic Tests for Coronavirus Disease-2019, and generally refer to settings that are equipped with the instrumentation and appropriately trained personnel necessary to perform the test, and may include settings such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.

Abbott keeps touting that 5 minute test time, however if you read the fine print it says "in as little as 5 minutes". Even a positive could take more than 5 minutes. It is a great tool for fighting this pandemic, but Pet is right--this isn't something you can just plug in and start testing. It needs to be validated (mod complex) and people need to be trained. It's not difficult to run, but there are things that need to be done correctly or the test cannot be completed. I do wish some of this could be put in the press releases. Of course, that might make it harder to sell. Although what we've heard is that it's not going to be easy to get reagents, even if you have the device, and it will be allocated. Still, the more "weapons" we have in our arsenal, the more we can help beat this thing.

I listened to an FDA webcast today and he was very adamant that the FDA does not make CLIA statuses.