Duplicate LLOQ and ULOQ [Bioanalytics]

posted by Ohlbe – France, 2020-05-26 19:43  – Posting: # 21482
Views: 1,309

Dear Helmut,

» » (in the past many labs analysed the LLOQ and ULOQ samples in duplicate, with only one of the results being used following an SOP, but all others were singlets).
»
» I see. How does such an SOP look like? Pick out the best?

Some just picked the one they liked best. I heard they ran into trouble :-D

Most frequent: use the first result only. If, and only if it fails (more than 20% deviation at the LLOQ, 15% at the ULOQ): exclude it and use the second. The aim being of course to avoid having to truncate the curve in case of failure.

I see this less and less often. Not sure why (guess: some FDA inspectors did not like it).

Regards
Ohlbe

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