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 have used this device in the laboratory setting. Even though it is waived, there is a learning curve. You need to follow the directions --(many steps)exactly on the tiny screen and timing is crucial. With that said, we were very relunctant to put this in the clinic setting. Eventually we did. I think it is a great testing device for what it results. And if it can deliver coronavirus results in 15 minutes. I think it will be a game changer. You do have to open up the specimen so it may have to be done under a hood depending on your safety policies.
Hi!
We use them in all 10 of our FSED locations around the state for flu, strep, and RSV. I will be very comfortable bringing on this COVID testing. I'm not sure exactly what Jane meant about opening up the specimen, as you should never open up the test cartridge, but I am probably not understanding her statement.
Mary Hammel
You have to open up the specimen to use the swab to innoculate the cartridge.
I would advise caution “on the device” being waived testing. Perhaps better to consider the flu and strep ID Now reagent testing stated by MIFU as CLIA waived.
Are folks also assuming that COVID19 reagent is approved as “CLIA Waived” ? Or you’d run it only under certificates supporting moderate testing?
Has anyone seen the MIFU document saying approved as waived? I haven’t seen a MIFU staying that. So asking.
Would love a copy if anyone did.
Thanks in advance.
Sent via Groupsite Mobile.
I think she means you need to open up the TVM container so the risk of droplet/airborne precautions need to be followed per lab protocol. We are using a face
shield with our FLU testing that we are performing on the IDNOW on all patients from our swab n go drive up clinic. We use the IDNOW for flu, strep, and RSV and it seems to work great. We have them in our family practice clinics and 3 urgent care clinics.
Ah, I see the confusion. For current Alere ID Now testing (flu, strep and RSV), swabs are collected at the bedside in the FSED and performed on site. No VTM. They place the swab back in the wrapper. We are a moderately complex site and so we can accommodate the moderate complexity of the COVID test. We are evaluating current collection techniques as well as implementation of some other PPE measures in their on-site lab for COVID testing. Be well! :)
From the paperwork I've seen, the Covid-19 test can only be run in mod or high complexity labs. It is only EUA approved.
From the package insert I have come across - and from my understanding of how the high complexity to waived process works - complete validations studies have not been performed (sensitivity/ specificity) and FDA only approved it as EUA. So it would be high complexity until it was approved by the FDA for waived status.
Adil
Here’s the link for technical info on Abbott’s new test
https://www.alere.com/en/home/products-services/brands/id-now.html
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The info I saw states that the device is approved only for Emergency testing. See wording from the Abbott website---since it is not FDA cleared or approved,
I would suspect it is highly complex and testing personnel will be limited to Lab and Respiratory??? If someone finds out differently, please let us all know.
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for
use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes
Warm regards,
Sonya Evans, MT(ASCP)
Point of Care Coordinator, Laboratory
Sonya.Evans@prismahealth.org
Prisma Health–Upstate
701 Grove Rd
Greenville, SC 29605
864-455-4494 (office)
864-390-1964 (pager)
864-455-7728 (fax)
Inspire health. Serve with compassion. Be the difference.
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https://www.fda.gov/media/136525/download
This is the FDA website that have the manufacture /package insert:https://www.fda.gov/media/136525/download
The EUA authorization for ID NOW COVID-19 states "Testing is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988.......to perform moderate complexity/high complexity tests. The ID NOW COVID-19 assay is also authorized to be distributed and used in patient care settings outside of the clinical laboratory environment."
A tad confusing when taken altogether.
By any chance does anyone have a procedure or competency for their current ID NOW that they would like to share? Thanks in advance!
Mary Wrenn
Newton Wellesley Hospital
mwrenn@partners.org
617-243-5473
We are also considering ID Now and I would love examples of procedure / competency / IQCP.
Thank you!
Stephen.wong@hhs.sccgov.org