Abbott ID NOW Users

Hi Cindy, 
We don't do a ton of Covids. We did 60 last quarter and 36 so far this quarter. We only had 1 covid invalid this quarter and 0 last quarter. We did have about 40 invalids last quarter and 45 this quarter- similar testing volumes for each quarter. We do strep, flu, rsv, and covids in our hospital and outpatient clinics. The biggest issue I see is the nursing turn over. The majority of our invalids are due to travelers. Invalids are about 6% of the total tests this quarter and last. There seems to be a learning curve with pushing down that transfer device.

We only see these sparingly. However, in my experience, invalid results are always user error in which the operator either did not depress the white cardtridge into the sample receiver until the orange pop up and/or they did not depress the white cartridge into the test receiver until the orange piece descends. 

hello,  our total invalids this year around 1.7%. Covid has the lowest ~ 1.3%, RSV - 1.6%, Strep - 1.8% and the highest so far is FluAB ~ 2.2%. We are allowing 1 repeat after the invalid result, and the repeated invalid rate is below 1%. 
Cindy, what is your invalid rate for Covid tests? Have you analyzed lot to lot variations?

Thanks for your replies, interesting numbers.  We have a much higher invalid covid rate.  Our analyzers are used heavily for covid, flu and strep and most of our operators are long time users.  I know Abbott looks at the analyzer logs to determine at what step the invalid occurs, hoping to hear back from them soon.

I was very surprised to get an Invalid ID NOW Covid this week because I hadn't had one in a while. I repeated it using the same sample extraction and it was Invalid. The provider recollected the swab and I tested in on a different ID NOW instrument using a new kit lot. Invalid again. I explained to the provider that it was patient specific, and to request a different method of detection. I believe it was recollected and a 4-plex was done on the Cepheid Gene Xpert and all were negative. Looking forward to hearing what Abbott discovers as the root cause.

Hello all,
To follow-up on issues some of us looked at with the ID NOW invalid rates within last 5 - 6 months -

Based on our recent experience, my suggestion to anyone who has been worried on a jump in invalid rates (based on data, tracking increased rates from your baseline) is to talk to your local Abbott rep about your concern - or - do open a case with Tech Service/Support. The supporting documentation/stats should be specific to lot#s. 
 
Peggy

Karin, I didn't realize 'all users' were getting those Field Correction Notices. Thanks for adding that. We got ours directly from the person handling our account problems.
Originally on this listserve, only FLU kits came up as a problem but in February we saw RSV lots much higher rates of 'invalids'. The Notice does list lot#s from all ID NOW tests. 

Karin, would you mind sharing that communication?  I have been to the website and could not find anything.  Surprisingly, Abbott tech support was not very helpful and is insistent that they were unable to send me the notice by email.

Hi Kimberly,
When a few of us on this list serve had issues with reagents for the Siemens Vantage A1c POC instrument and went to our local reps and Tech Support for the 'affected lot# lists', we were refused. We were told the info would be sent out through the seller (I stupidly thought Siemens was the seller of their own products, but no, the distributor is the seller per Siemens). 
I don't know if that is the case with Abbott or they are only sending to those who reported problems and have active cases. 

Thanks Peggy.  It was apparent that they didn't want to disclose information without an active case number.  That is disheartening.  If it is known that a product is problematic, one would think they'd want us all to be aware.  If they want proof of lot numbers for replacements, that could be achieved rather easily on the back end.  I appreciate your input!

Yes this is a bit disheartening because we would expect our manufacturers to be more forthcoming with important Field Correction Notices. Since Abbott may still be working on the root cause I recommend submitting a Tech Support request and stating that you're noticing more Invalids than usual like we did. This is what initiates the process. I agree with Peggy, you probably have to make first contact. But that's what's great about this Listserv! I was glad to see that we're on the same track. Yes, also Siemens goes through their Vendors for a lot of their consumables and even the Clinitek Status Connect hardware. Every company has their own policies so if I'm told to contact the vendor, I just do that and go that route. 

Thanks all, I have instructed my clinics to call in any issues with recurrent invalid results to Abbott Technical Support and open a case/ticket.   

Hi Karin,
Thanks for sharing. That is excellent advice for all of us.