ioanam
★    

Romania,
2010-08-10 00:37
(5800 d 09:21 ago)

Posting: # 5747
Views: 3,677
 

 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
(5800 d 06:44 ago)

@ ioanam
Posting: # 5748
Views: 2,939
 

 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
(5800 d 00:06 ago)

@ ElMaestro
Posting: # 5750
Views: 2,854
 

 calibration curve

Thank you very much.
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
328 visitors (0 registered, 328 guests [including 19 identified bots]).
Forum time: 09:59 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5