Alere I validations
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Hello everyone!
We are bringing the Alere I to our clinics and testing for Flu A/B, RSV, Strep Group A.
Since this is a "waived" assay, for those using this system, what is the best way to validate this? So many options. If you could share your validation experiences that would be great! We currently use BD Veritor. Do I have to do a comparison study? I feel that I don't since this is a Molecular vs Ag/Ab. There is no comparison between the two systems.
What have other labs done????
Thanks,
Julie Brim, CLS POC
The Vancouver clinic
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We just placed 5 Alere ID Now in our ED department back in January. Alere sent Rhonda to validate our instruments for Strep A after I complained about them not validating and only doing user training. (We were already using the Alere ID NOW in the LAB for INFLU and RSV but not Strep A). Alere supplied two boxes of NATrol Respiratory Verification Panel (catalog # 0830087). It includes positive and negatives for Strep A, FLU A & B and RSV. Rhonda Aucutt is the person who came out to do our validation for Strep A. She was extremely helpful. Her e-mail is Rhonda.Aucutt@alere.com Her phone is (224) 325-2829.
I was told that comparison testing was not needed because we were doing manual strep As by non molecular methodology.
Hope that helps.
Char Swanson
POC Coordinator
Hi Julie,
If your lab director/POC director feels it's a good idea to 'validate' then perhaps a good idea to run this by the manufacturer's rep working with you to set up training. See what is made available to you by that particular rep and if she has a technical person working with her who has validated other instruments by bringing in the reagents and the means used to validate (do you want to validate against the manufacturer's claims? use patient collections that are also run in your micro or molecular lab?)
On the comparison question - I lean with you. The reagents are in my estimation too expensive to do a comparison just 'to show they don't compare'. We didn't do one. Going back way before we implemented in a clinic a micro fellow compared BD Veritor to two different molecular instruments. It was considered an academic study.
Hello everyone,
Our Emergency Department is looking at the Abbott ID Now for flu, step A, and RSV. I was wondering if there have been any issues with your ED performing the testing. Our ED already does a lot of POC testing and I am worried about the integrity of the testing. Also, how do the operators like the instruments?
Are your instruments interfaced via a middleware? We are looking at a RALS interface.
Thanks, Kerri
Kerri Chalk, POCC