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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Good Afternoon,
Please know that the CDC recently updated Biosafety Guidance for POC COVID-19 testing.
https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html
Thank you,
Maureen
Please consider the environment before printing this e-mail
Cleveland Clinic is currently ranked as one of the nation’s top hospitals by U.S. News & World Report (2019-2020). Visit us online at http://www.clevelandclinic.org for a complete listing of our services, staff and locations. Confidentiality Note: This message is intended for use only by the individual or entity to which it is addressed and may contain information that is privileged, confidential, and exempt from disclosure under applicable law. If the reader of this message is not the intended recipient or the employee or agent responsible for delivering the message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please contact the sender immediately and destroy the material in its entirety, whether electronic or hard copy. Thank you.Thanks Maureen for the link! Appreciate this.
Under the POC guidance, I see no recommendation per se to use a biosafety cabinet. Does mention a shield/barrier to work behind or could mitigate with a face shield/masks. Interesting that it doesn't state related to 'if swab testing rather than viral media testing'...
Hello,
Since the market is becoming flooded with a variety of Covid testing platforms which are you using in your Urgent Care settings and how confident are you with the results?
I validated 3 Sophia 2 instruments and got an overall 87% sensitivity rate. The Urgent Cares do not intend to confirm negative tests. I am not sure how comfortable I am with that decision.
Anyone familiar with, or using saliva covid testing?
Please send me your thoughts.
Thank you,
Gail
Inspira Health
Our lab runs covids and flus on the Cepheid genexpert. The vendor is phasing out the individual test cartridges to a combo Sars/Flu/RSV. I've been asked to validate the flu and covid-19 on the Abbott ID Now but our positivity rate is low and will be hard to find positive patient samples for the validation. How did your facility validated the assays? Did the validation included all sample types?
thank you
Following CDC recommendations we'll be adding several layers of protection including biohazard shields, face mask, face shield and or goggles.
Francesca,
The Abbott ID NOW is waived.
FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations. https://www.cdc.gov/csels/dls/locs/2020/fda_clarifies_clia-waived_status.html
I am getting 8 Abbott ID now to run Covid and Flu, and interested to hear from the group how your lab validated the tests.
Thank you,
I have been evaluating three rapid antigen tests, one being the ID NOW. You do not need to perform a performance verification on it, but the vendor does have a validation protocol you can follow if desired. Its a great validation plan, but TOTALLY unrealistic $$$.
My personal opinion, if you want to pursue validation, I would collect 2 specimens at your locations with highest positivity rates. Label one specimen with patient info and freeze/refrigerate, and send the other specimen to its intended testing platform (molecular ideally). I would then retrieve the frozen/refrigerated swabs for ID NOW testing after flagging positive on your molecular method.
Alternatively you could sample the VTM from positive PCR samples in your lab, but this is very problematic for many reasons (e.g. dilution of antigen and unacceptable specimen type on ID NOW).
Let us know how it goes :)
Please do not use frozen specimens to perform validations for COVID-19 on the ID Now. You will want to reach out to your Abbott Technical Consultant- they can provide you with specific guidance you will need to perform the validation study..
The sale rep told me that Abbott didn't have a validation kit for covid and it was up to the discretion of the lab to validate using QC material or patient samples. My concerns with using patients is our low positivity rate. I am trying to connect with the technical consultant. Did you validated the cartridge?
Yeline,
When I inquired about the validation kit our technical consultant told me the same. They're not issuing a validation kit as they haven't validated the ZeptoMetrix NATtrol Respiratory Verification Panel. His opinion is that conducting a small validation study of 5 samples would suffice. Like you said, the problem is the low positivity rate. We haven't started testing yet, we haven't received our kits so I have a little time to figure it out.
For those who are already testing, how did you validate?
Thank you,
Ramona
Joseph,
We've been using Alere i/ID NOW for 2 years. I have no complaints about it. When compared to strep culture the sensitivity is comparable. We don't have many invalids. In my experience when we have invalid or discrepant results they are due to improper specimen collection, storage or user error.
How often do you decontaminate the ID NOW. When running multiple tests do you change gloves after each test?
Ramona,
Before days of COVID, we followed the MIFU/Abbott trainer with wipe down end of day.
When we put ID Nows into COVID assessment centers for flu and strep testing (using exam rooms for the testing locations), we moved to wipe down after each patient (along with entire room).
If we add COVID reagent in clinics then we will do wipe down after each test.
How has the supply chain been for the ID Now? Is there still an allocation on the instruments and reagents?