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Passing-Bablok & weighted-Deming

Emmanuel_Romeu

Hello,

According to CLSI EP09-A3 various regression techniques are available to assess the linear relationship between 2 analytical methods. Deming (D) is implemented within JMP as Orthogonal Fit. What is missing are 2 methods which are more appropriate for most (if not all) chemical or immunological assays (oncology, virology, cardiovascular, inflammatory medical devices) i.e. weighted-Deming (wD) which take care of the heteroscedasticity of the measurement (that's always the case for immuno-assays) and Passing-Bablok (PB) which in addition is robust to outliers (that's often the case). The later (PB) being the best in class and most commonly used in the field.

For that reason Analyze-it (EXCEL add-in) is still used for regulatory submission (FDA, cFDA, CE marking) rather than JMP for linear regression assesment.

Emmanuel (former Beckman-Coulter employee)

Status: Delivered

Comments

geoffrey_mann

Hi Emmanuel,

Thanks for bringing the topic up again and I agree that it is time to get these methods into JMP. I for one will add my vote!!! I spoke with Russ Wolfinger because he had done some work with another customer getting the Method Comparison addin (https://community.jmp.com/t5/JMP-Add-Ins/Method-Comparison/ta-p/21520) working using Passing or Bablok. Notice there has been a fair amount of discussion on the topic. There are regulatory authorities using this addin as well. I will discuss with others here at JMP that I know will want to see this, including maybe Russ Wolfinger, Don McCormack and Mark Bailey?

martindemel

I know that Roche has build their own deming regression add-in as it was not available in JMP.

Emmanuel_Romeu

Yes indeed, and I was using it at Beckman-Coulter. That being said it is not so practical and cannot be used for submission purpose unless validated which is not worth the effort (at least within Beckman-Coulter).

Audrey_Shull

I can report that there has been work in this area for JMP 17. Passing Bablock analysis is now available in Fit Y by X, as an option for Bivariate regression analysis. JMP 17 will be available externally in fall of 2022.

martindemel

@Audrey_Shull can it still be tested in the EA version? Then I may inform our Roche power users to test it specifically.

Audrey_Shull

Hi @martindemel - the first implementation of a Fit Passing Bablok option DID make it into EA7. EA7 is currently available to those in our Early Adopter program. I do see that there has been additional work since then, to add two options to the Passing Bablok Fit (specifically, options for the Equality Line and launching Matched Pairs). Please be aware of that if you do recommend it. The next Early Adopter release will be available in mid-May.

martindemel

Thanks @Audrey_Shull . I will consider this when talking to them! hopefully they have time as I remember in 2018 we talked to Laura and Chris about it with Sebastian and Andrea from Roche. So I believe it would be of value if they could take a look on it

Emmanuel_Romeu

I just tested it, that is a great addition !! thank you.

Sarah-Sylvestre

mia_stephens

This functionality was added in JMP 17. Marking as delivered.