QC sample levels in each run [Bioanalytics]
Dear Ohlbe,
So when the EMA-BMV guideline says:
"the LLOQ, within three times the LLOQ (low QC), around 30-50% of the calibration curve range (medium QC), and at least at 75% of the upper calibration curve range (high QC). The mean concentration should be within 15% of the nominal values for the QC samples,"
what it actually means is HQC should be 75-85% of ULOQ. Right?
Regards,
Ladi
❝ "the upper limit of the acceptance range (750 + 15 %) is 862 ng/ml, which is above your ULOQ. You will certainly get some results above 800 ng/ml, but as you are not supposed to extrapolate above the ULOQ you won't know whether they pass or fail. Your HQC concentration should not be above 695 ng/ml (upper acceptance limit 799 ng/ml)."
So when the EMA-BMV guideline says:
"the LLOQ, within three times the LLOQ (low QC), around 30-50% of the calibration curve range (medium QC), and at least at 75% of the upper calibration curve range (high QC). The mean concentration should be within 15% of the nominal values for the QC samples,"
what it actually means is HQC should be 75-85% of ULOQ. Right?
Regards,
Ladi
Complete thread:
- QC sample levels in each run TK 2015-09-15 12:22 [Bioanalytics]
- QC sample levels in each run Ohlbe 2015-09-15 12:54
- QC sample levels in each run TK 2015-09-17 05:01
- QC sample levels in each run Ohlbe 2015-09-17 10:35
- QC sample levels in each runLadi 2015-09-17 13:58
- Concentration of HQC Ohlbe 2015-09-17 14:48
- QC sample levels in each runLadi 2015-09-17 13:58
- QC sample levels in each run TK 2015-09-21 04:57
- QC sample levels in each run Ohlbe 2015-09-17 10:35