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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I don't want to start anyone down the wrong path, so please know that i am just relaying what i have been trying to work through so far for IDNow Covid19. In trying to figure out what EUA actually means compliance wise, I have been following CAPs guidelines for EUA tests. At this very moment, CAP states that you can write an IQCP-it's in the FAQs on their website. I know that Abbott has that in their IFUs but I was told by 3 Abbott reps that the IQCP statement would most likely be take out of the IFU. That was before CAP changed their tune from it not qualified for IQCP to now you can. I know the two entities have been working together to come to an understanding but i just have not heard from Abbott on what the determination was. Haven't heard for 2 days.
Adonica, CAP initially said follow CLIA/CAP rules for QC, which means two levels QC/day/instrument. CLIA actually says 2 levels per procedure. With CAP saying IQCP is ok, it's leaving the discretion to the lab and I am assuming that most would follow manufacturer's instruction. But again, i am waiting to hear Abbott's response.
I also want to say that there are concerns here too with this test not being done under a hood. We have seen some contamination issues with the flu test if you get a lot of positives and don't keep it clean.
Peggy that is a great point. We have our staff run a negative control if they feel there are too many positives in a row, just to rule out the possibility
of contamination. But one thing to remember is if you run a negative control, you have to run a positive, so we have them run the QC as a patient so we do not waste reagents. The only time we run it as QC is when we are doing QC on new shipments or lots.
Is anyone allowing nursing staff to perform Abbott ID Now COVID testing outside of a very controlled environment? Or is the testing going to be performed only in the lab? I am trying to gather information for performing POC vs. in the lab.
Thanks, Kerri
Kerri Chalk BSMT (ASCP)
Does anyone have a Procedure/ competency/ IQCP they would like to share for the Abbott ID NOW Test device?
Also does anyone have the ID NOW interfaced using Rals as the DI into Epic?
mbannist@mdmercy.com
Thanks!
Hi Megan. I have a procedure for Flu and Strep but not COVID if you are interested. I also use RALS and we are switching to EPIC. I would love to talk to you
at a later calmer date to see how you like the interface and to get any tips you may have.
Hi Megan. I have too have a Strep and Flu procedure. We are interfaced for Flu through RALS into EPIC. This device does not require IQCP as it is a waived device. We require yearly competency. Feel free to reach out if you'd like to discuss. jetellez@luriechildrens.org
API (American Proficiency Institute) has a PT set for SARS-CoV-2 testing available.
(https://www.api-pt.com/catalog.aspx)
SARSCoV2.pdf
Good morning! We just found out that we are getting an ID NOW for COVID. Interested to hear how current users feel about the test. Also interested to see examples of training documents and operating procedures.
We'd have to do the testing in our lab/POC due to the complexity so we're trying to think logistics. Any ideas would be great!
Thanks!
Jessica.lang@stelizabeth.com
We got them in as a system and ended up returning them. They claim it’s a POC device because of the EUA, however, I would not want that out in the field. We were
actually going to do the testing in the lab and under a hood due to the way you have to mix the sample, you’re creating a chance of aerolization. Also, when attempting to validate, two of my “positives” from PCR testing, came up as negative. It will not pick
up low viral loads. So many false negatives. Good luck.
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Anastasia, can you please post the study you heard about? This seems a little biased to post hearsay on a group information chat such as this
Good Morning,
The ID NOW for Covid has been widely spoken about in the media.. I am hearing whispers that its specificity is sub par??? thoughts?
Thank you and stay safe ,
Ann
I just ask me our Micro department about ID Now false negatives. I was told you get them if the swab is in the media so now they are getting dry swabs. More to
come. Everything about this virus is evolving.
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Agree Sandra.
We switched two weekends ago to put the NP swab into a tube to transport to lab (we are running ID Nows from inside the labs, not inside assessment centers). We started out putting NPs into viral media so when the sample 'hit the lab', there were options on platforms depending on how the volume was at the time the first responder/HCW sample was collected due to positive screen.
I have not seen the stats yet but hope I get the opportunity because I'm very curious before and after using direct swabs.
Our Abbott account exec immediately notified us when it was figured out about the sensitivity and presumably false negatives.
Also anyone using ID Now - be sure you 'fix' the settings/selection if switching from using viral media to swabs!
We are still struggling to get NP swabs and they do not come in the ID Now covid reagent boxes - the nasal swabs only are supplied.
Wishing everyone continued good luck finding swabs, reagents, enough testing availability.
its a transport media issue.. Abbott is changing EUA.. it must be direct swab
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