Smitha
☆    

India,
2015-09-01 12:54
(3131 d 08:42 ago)

Posting: # 15370
Views: 7,115
 

 Urine Drugs of abuse test [Study Per­for­mance]

Dear all,
The urine drugs of abuse test is performed at Check-in for a Bioequivalence study. The requirement of the Study protocol is that the volunteer should test negative for this test.

Pls opine on the below points
  1. Is it ok to retest the volunteer if his result is positive?
  2. Does the retest have to be done from the same sample or a fresh sample?
  3. How many times should it be retested- first result: positive, second result: negative- to include or exclude the volunteer?
Have gone through the Forum Q and noticed that there was some disussion on this previously too with the opinion that the subject should be excluded.

Would appreciate the Member's opinions on the above points.

Thanks and regards,
Smitha
Dr_Dan
★★  

Germany,
2015-09-01 18:21
(3131 d 03:14 ago)

@ Smitha
Posting: # 15372
Views: 5,323
 

 Urine Drugs of abuse test

Dear Smitha
The urine drugs of abuse test is a Yes/No test, i.e. the test is either positive or negative. In case of a positive result you can not repeatingly test until you get a negative result just in order to include the subject into the study. If you doubt the test results why not re-test the negative outcomes? From a safety point of you this would be the right procedure.
I hope this helps.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
Smitha
☆    

India,
2015-09-03 13:54
(3129 d 07:41 ago)

@ Dr_Dan
Posting: # 15375
Views: 5,137
 

 Urine Drugs of abuse test

Thank you Dr. Dan
unique_one
☆    

India,
2015-10-09 09:01
(3093 d 12:34 ago)

(edited by Ohlbe on 2015-10-09 10:03)
@ Smitha
Posting: # 15538
Views: 4,518
 

 Urine Drugs of abuse test

Dear Smitha,

You should not repeat the test in any condition. However, be sure about the test kit which you are using for the UDS is acceptable for the use and was stored in the required temperature conditions.

The results that you have obtained in the first attempt needs to be documented and accepted.

Regards,
unique_one


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
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