Duplicate LLOQ and ULOQ [Bioanalytics]

posted by Ohlbe – France, 2020-05-26 21:43 (1423 d 00:36 ago) – Posting: # 21482
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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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