Invalid Flu B cases on ID Now platform
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hello POC people, recently we have started to see more and more invalid Flu B results on ID Now instruments.
Sometimes it is in parallel with positive Flu A, but it could be both invalids or Flu A neg and Flu B invalid.
We have noticed at least one case where patient had Flu A - Pos, Flu B - Invalid, and Bordetella pertussis positive, so it is possible interference for Flu B.
Those who uses ID Now, have you noticed any Flu B invalids spike up recently?
I am going to call Abbott tech support and/or talk to our rep as well, but was wondering if it is just us in Idaho (with sharp increase in whooping cough cases) or it is everywhere.
Thank you for your time and Happy Holidays!
Sometimes it is in parallel with positive Flu A, but it could be both invalids or Flu A neg and Flu B invalid.
We have noticed at least one case where patient had Flu A - Pos, Flu B - Invalid, and Bordetella pertussis positive, so it is possible interference for Flu B.
Those who uses ID Now, have you noticed any Flu B invalids spike up recently?
I am going to call Abbott tech support and/or talk to our rep as well, but was wondering if it is just us in Idaho (with sharp increase in whooping cough cases) or it is everywhere.
Thank you for your time and Happy Holidays!
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Please let us know what you find out and Happy Holidays to you!
Thanks for your post.
Can't wait to hear what Abbott Tech Support tells you (or however the scientific theory/explanation comes to you...the authorized source!).
Did Abbott Tech Support request you download log files and submit them for interpretation?
What has come to some attention here is one Urgent Care testing site, in particular, that had an alarming increase in 'invalids'. I can't say (because I don't know) what the breakdown of the increase in invalids have been until recently, due to reading your timely post (most of the ones I've looked at are A and B both 'invalid' but a couple were Flu A positive/Flu B invalid).
"Please be advised of some of the potential causes of these occurrences:
- assay reagents not functioning
- Transfer Cartridge not aspirating or dispensing a sufficient volume of sample to the Test Base
- User error
- Off-label / unapproved sample types
- Bloody samples
- Incorrect kit storage
- Instrument malfunction
Yet, in order to facilitate the investigation for this case, kindly help provide the requested information below:
PATIENT DETAILS
- Was there negative/ significant impact based on ID NOW Influenza A & B result?
- If yes, would patient details be available to be shared?
TROUBLESHOOTING
- Was sequential testing used (was the sample receiver used to test for COVID-19 as well as Influenza)?
If so, which assay was tested first and was the second test initiated within 30 minutes of the completion of the first test?
- In reference to the photo shared with us (see attached), are the logs all from the same/ one site?
a. How many Invalid results have you received?
b. Dates and times of invalids - How is the Kit stored and has the test reached room temperature before use?
- Is "Invalid, possible dispense issue" displayed?
- Was the "procedural control valid" displayed?
- Was the kit swab used, if not what swab type was used?
- Was the swab tested directly?
- What was the sample type?
- Was the sample tested immediately or stored before testing?
- After the sample was collected how did you perform the test?
- Are tests repeated after an invalid result?
- If yes, was a new sample collected or was the test repeated using the same Sample Receiver?
- What cleaning materials are used (solutions, wipes, swabs, etc.)?
- Was the retest successful? If no, do you have a new kit with different lot to retest with?"
Right now, I am trying to process (digest lol) all this requested information, and see if we have any possible pre-analytical or analytical issues.
But, I am very confident that we do not have any pre-analytical errors especially when we have Flu A positive, but Flu B Invalid, on very random operators.
We have 11 instruments, and about 20 operators. All together running about 1-2 boxes per day.
Thank you for your interest on this topic.
Happy New Year!
I've been checking (here) on the FluA getting a result while the FluB in invalid and, while there is still a high number of invalids, both FluA and FluB are invalid.
Keep us posted as you are able.
Appreciate you sharing.
One thing which has helped us (in training newbies) I believe has decreased some of the new user 'technical error' is that we train after 'stirring the swab' in the sample cup, to pause before putting in the white (pippette) piece/component and look for bubbles to not be in the center of the blue cup. We train to 'gently push' the bubbles away from the center using the swab, if bubbles in the center do not migrate to outside (we weren't having success trying to 'break the bubbles' but pushing them seemed to help).
I know you know to do surveillance on the white piece clicking/button movement. Our new hires were afraid they'd break something so it can be a challenge to use enough pressure from both sets of fingertips equally and not quit the pressure too soon.
Hope you are able to resolve this expensive problem.
So many variables that need to be investigated. UGH!
I've seen a few Invalid Flu B tests since you opened the discussion. I do believe that ours are due to operator error as we're having a little trouble with operators following the directions and or understanding the process especially with the sequential workflow.
I am going to continue to monitor this issue as well.
I am curious if one is able to run a Flu A/B test first, saves the blue receiver then runs a COVID second if the results are valid..............as I'm sure that it's already been thought of and done.
Theoretically, you can reuse blue chamber for covid test, after FluAB test. BUT, you can do it only once, because the blue chamber goes through a heat cycle for each viral test, and the manufacturer do not recommend more than two heat cycles. In theory, it is also possible from the NP swab to run Covid, "reflex" to FluAB (reflex skips a heat cycle) and then reuse a blue chamber for RSV test (second heat cycle), but this process requires precise lab skills. Officially not recommended, but 4plex from one swab. :)
Where I work, after all of our ID NOWs did the software version upgrade using Abbott's POC Link (required by Abbott to us), the version of software 'sets up' the instruments that we must perform covid testing FIRST, then an option after the test results allows to continue (to use the same blue sample cup) to perform flu. The time to perform flu is decreased. Also I'm not sure how since I am 100% not involved in charging/billing patient, doing the sequential testing affects the cost to the patient.
In this scenerio, operators must perform covid first and that's dictated by the 'sequential testing/'combo' procedure related to the software.
My ambulatory/clinics have a total of 142 (today) instruments.
Not related in particular to the 'FluA resulted/FluB 'invalid'', but to the increase in invalids particularly in 1 urgent care, we think it's possible there are a couple of reagent lots which could be involved in the problem.
I may have missed it in the Abbott Tech Support/Service reply except for this:
- assay reagents not functioning
In your case, does your lab buy and distribute all the reagents/ boxes, or does each individual testing site/clinic buy their own, get in their own stock, keep their own inventory?
Are all instruments using the same lot# at the same time?
Due to the volume of testing, number of instruments we have, we could not possibly do that.
Regarding your second message, yes, it is highly possible malfunctioning reagent kits are involved in this issue, and we had this happened before. Unfortunately, it takes a lot of work to prove it, but Abbott always reimbursed us on those bad reagents when we proved it.
We distribute all the reagents from a single inventory hub, and we run QC on each local shipment (between 10 locations).
Within last month, we run around 920 FluAB tests with 18 invalids (~2%), 4 of those had FluA pos, Flu B - invalid. All invalids are happened at 4 locations (the busiest locations), there were 11 different operators involved, and 6 different FluAB reagent lots. It looks like this month (January 2025) we have significantly less Flu A resulted, FluB invalid results. But still tracking it.
Have a wonderful day!
My Invalid Flu B results were in parallel with a negative Flu A using the sequential workflow process so maybe mine were due to a reagent or sample issue. My facility is definitely not running as many Abbott devices as yours and Peggy's. I really appreciate this discussion as I'm always nervous when implementing a new test. Thank you so much for your input!
Our ID NOWs have the software version upgrade as well for the sequential testing. But you know how it is, those operators try and reinvent the wheel wehn it comes to POC testing.