ID Now
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Want to opinions of ID now from? Is it a good POCT platform to bring in house?
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Correct the Abbott’s ID Now test is high complexity per FDA.
I am totally onboard Dr Khan’s post.
Sent via Groupsite Mobile.
Information regarding the COVID-19 test on the Abbott ID Now can be found on Alere.com. Check out the "Helpful Documents" section for the package insert and more. Thank you!
Don't forget to all current ID Now users - to add COVID19 testing, you'll have to do a software update on each analyzer. Then run all the analytes' QC control swabs for the analytes you want to continue to perform on that analyzer.
Not a big deal for those who are just adding analyzers but for those of us who have been using at multiple screening sites with multiple analyzers at each (eg performing flu or strep as part of the 'suspect COVID+' screening process), it may mean quite a bit of extra work to factor in if you are covering this aspect. Especially in systems where screening/testing respiratory assessment centers are geographically distant to each other (spread across the healthsystem).
It is kind of wild that throat, nasal, NP swabs all can be used for the ID Now COVID19.
For Use Under an Emergency Use Authorization (EUA) Only
For use with the ID NOW Instrument
For use with nasal, throat or nasopharyngeal specimens
We are looking into getting a few. If anyone can share their procedure and competency for it, I would greatly appreciate it. Thanks!
maryjeanne.altura@utsouthwestern.edu
Good to have you back, Sam Bijani! Sherri and Theresa
Yup, Sam, a tad confusing. Also add in an Abbott employee telling customers COVID19 is waived testing. Wrong.
Handling Respiratory Assessment Centers is no easy feat to begin with.
Can someone provide the document or the link that states ID NOW COVID-19 is a high complexity per FDA?
Hi for the mention of high complexity, go back up to Wanda's post's link.
In the MIFU look at the next to last line in the first paragraph. It says 'moderate/high' complexity but there is speculation that since the FDA agreed to Abbott as emergency use, maybe we have to consider using as high complexity.
It's confusing to some of us who are type A, OC and we like it in writing and clearly stated how to handle, what to DO.
Sam, we are not going to allow you to leave POCT ever again. Especially not over COVID testing!
Opening the specimen container under microbiology hood and inoculating the cartridge should guarantee no aerosol contamination of the tester. After the cartridge insertion, it should be a closed chamber for testing.
I have only seen a demo of ID Now.
What validation procedure should be followed before a COVID-19 result is reported?Everyone in my lab wish we have one. Our results from a private lab takes 6-7 days before a report is generated. Unacceptable but what can we do.
We have about 35 of the ID Nows within our program. We have been perform Strep A, Influenza A&B, and RSV. They are great workhorses but the testing does take time. When training you have to really emphasize the correct technique to the end users.
I took the wording to be if you have either a mod or high complex lab that has this instrument you can perform testing as long as you follow the rules of the EUA. The minimum for using this test would be a mod complex lab. If it was approved to be used only as high complexity would it have said Mod/High?