Hello, sorry for the late reply, I have just returned from PTO..
I agree bridging is not required if data has not been generated with the version 1 kit. In term of partial validation, in addition to P&A runs, you may also inquire whether the beads change affecting kit/reagent stability.
@Karen Quadrini @
[email protected] have experience with this NfL kit change. Looping them in for comment.
Kind regards,
Yan
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Yan Ni
Executive Director
Passage Bio
Philadelphia PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 12-06-2022 07:12
From: Anonymous Member
Subject: New SIMOA NFL v2 kit and partial validation
This message was posted by a user wishing to remain anonymous
Hello,
thank you for your input.
The 2 versions are still available. However, we used the V1 kit only for validation and not yet for clinical sample analysis.
Therefore, I thought that it would not be necessary to compare the 2 versions of the kits and that only showing that the new version of the kit has good performances could be sufficient.
Kind regards.
Original Message:
Sent: 12-05-2022 11:51
From: Amanda Hays
Subject: New SIMOA NFL v2 kit and partial validation
Hello,
Thank you for submitting this question to the group. Are the previous version kits available to conduct a comparison between both versions of the kit? I would tend to think that 3 P&A runs would be appropriate for a partial validation, to include endogenous QCs in those A&P runs. If the previous kit version is not available, you can at least compare to historical data from the previous kit.
I'm also adding in @Yan Ni for experience with Nf-L.
Best,
Amanda
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Amanda Hays Ph.D.
Scientific Officer
BioAgilytix
Olathe KS
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 12-01-2022 10:47
From: Anonymous Member
Subject: New SIMOA NFL v2 kit and partial validation
This message was posted by a user wishing to remain anonymous
Dear members,
Quanterix released a new version of their Nf-L kit called v2. In this new version, they have implemented a new type of beads but all the rest remain unchanged.
We have just completed the validation using version 1 of the kit but this kit is no longer available. We are considering a partial validation but are wondering about the extent of it. I would really appreciate your input.
Would 3 P&A runs be sufficient? Do we have to compare the 2 kits or only use v2 kits for this partial validation has no data from clinical samples has been yet generated?
Thank you.
Kind regards.