ioanam
★    

Romania,
2010-08-10 00:37
(5795 d 10:35 ago)

Posting: # 5747
Views: 3,640
 

 calibration curve [Bioanalytics]

Dear all,
I have a question about evaluation of some data outside the validated calibration curve range.

I received from the analysts the following results:
In the pre - study validation we have:
LLOQ - 10.010 pg/ml
calibration curve range- 10.020 to 10015.000 pg/ml

In the in - study validation it is mentioned the same calibration curve range.
On the other side, there were reported several cases of individual plasma concentrations over 10015.000 pg/ml (in some cases almost 15000 or even 18000 pg/ml).

Do we need to reanalyze these high values? How can I evaluate the results in this situation?

Thank you very much for your help,
Jo
ElMaestro
★★★

Denmark,
2010-08-10 03:14
(5795 d 07:58 ago)

@ ioanam
Posting: # 5748
Views: 2,906
 

 calibration curve

Hi Ioanam,


❝ Do we need to reanalyze these high values?

Yes (meaning: you need to reanalyse the samples that caused the high values).

❝ How can I evaluate the results in this situation?

Your validation probably includes dilution integrity. You dilute by a certain factor and get a signal that corresponds to somewhere between LLOQ and ULOQ. Then you multiply with the dilution factor.

Pass or fail!
ElMaestro
ioanam
★    

Romania,
2010-08-10 09:52
(5795 d 01:20 ago)

@ ElMaestro
Posting: # 5750
Views: 2,828
 

 calibration curve

Thank you very much.
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