Abbott ID NOW
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We are looking at the Abbott ID NOW for our provider offices, however I am questioning the statement under the limitations:
Additional follow-up testing using the culture method is required if the result is negative and clinical symptoms persist, or in the event of an acute rheumatic fever (ARF) outbreak.
If you are using this instrument, how do you make sure that this is being enforced if you are not requiring a culture confirmation on all negative specimens?
Thank you!
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This is an old requirement, the current test does not have this requirement. I suggest talking to your Abbott rep.
Agree with Kathleen's suggestion. Our Pediatricians are not sending 'routinely' for culture with negative streps. As they did before we transitioned to waived PCR/'molecular' testing.
Kathleen and Peggy, that limitation Cindy states is actually still in the Abbott package insert for the test.
Cindy, I saw that when we brought this test on in November of last year also. I made this statement a large part of our test procedure. Since there is no way to effectively track patients whose symptoms persist; we are trusting our Providers to use their clinical judgment.
I agree it's still in the package insert that ABBOTT includes. I asked about it repeatedly to our POC Director before the decision on product/instrument was made by faculty. As I stated, he's sticking with ABBOTT's "do not have to send negative streps out for culture".
But I also agree with Kathleen that 'talk to your Abbott rep' or the Abbott account exec. That's why our Pediatricians clammered for transitioning to a PCR or molecular waived test.
What I'm not sure about is how the strep SOP will state confirmations. Before it was left up to the providers - regardless of what the printed package insert stated.
Have a nice weekend all!
For our test procedure we have just made a note of the "ARF and clinical symptoms persist" verbiage at both the policy/intended use/background area and in the result interpretation sections; leaving the decision on confirmations to the Providers clinical judgment.
Max, I think that is the way we'll also do it. As in 'type in the sort of disclaimer statement' in the Abbott MIFU (on clinical symptoms persisting).
We haven't updated the previous SOPs when the instrument was Alere i.
In process.
Thanks Max.
Thank you all for your input. I greatly appreciate it. I am hoping to meet up with our rep soon to discuss this as well.