12 December 2023 1 2K Report

I am studying precision for my assay/kit with the following parameters followed:

Panel members to be tested:

1. Weak positive

2. Medium positive

3. Strong positive

4. Negative

All these were panel members were tested in triplicates in three lots of the kit tested on 3 days, at 3 different sites by 3 persons.

Now, I have to calculate inter assay variation, intra assay variation, person-to-person variation, day-to-day variation and site-to-site variation.

Please help me if this assay design is correct to calculate the precision of the assay and how to calculate the variation mentioned above?

Thank you in advance.

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