German to English translations [PRO]
Science - Other | | German term or phrase: Freigabepanel | Aus einer Leistungsbewertungsstudie für einen Testkit. Es geht um die Probenherkunft, bzw. Probenspezifität.
Die Proben der Blutspender stammen aus dem ELISA-Freigabepanel. |
| CArcherKudoZ activityQuestions: 85 (none open) ( 2 closed without grading) Answers: 35
Germany
| Local time: 04:19
|
| | release panel | Explanation:
"ELISA release panel"
A new FDA lot release panel for antibody to Human T-Cell
Lymphotropic Virus, Type I (HTLV-I Release Panel 1) is now
available for distribution by the Center for Biologics Evaluation
and Research, FDA. The purpose of Panel 1 is for the qualitative
and semi-qualitative evaluation of in vitro tests to detect
antibody to HTLV-I in human serum or plasma. It is a regulatory
panel similar to the HTLV-III Reference Panel 2. The HTLV-I
Release Panel 1 is designed to provide a release criterion for
lots of HTLV-I antibody detection kits produced by licensed
manufacturer or lots of produced by manufacturers pursuing
licensure of such tests and should not be used for experimental
or other reference purposes. Due to the expected large number of
requests for this panel, Center for Biologics Evaluation and
Research will limit the distribution of the panel when necessary.
http://docs.google.com/viewer?a=v&q=cache:MZwrXjNVhU8J:www.f...
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Note added at 25 mins (2010-01-25 10:03:15 GMT)
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Lot Release Panel to test lot to lot consistency
CBER Lot Release Panel developed
http://209.85.229.132/search?q=cache:DNmIQRE9bSgJ:www.who.in...
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Note added at 38 mins (2010-01-25 10:17:13 GMT)
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Manufacturing controls
* Aim is to minimize within-serial and serial-to-serial variation by ensuring consistency of production – Outline of Production
* Master Seed/Master Cell concept
* Validation of new lots of antibody/antisera
* Serial release testing of serum or antigen panel with range of reactivities and cross-reactivities
o Serial release panel is critical to minimize variation in test results
o Panel includes range of reactivity
http://209.85.229.132/search?q=cache:Igw5R2Huo4UJ:www.fda.go...
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| Selected response from:
 Marga Shaw
Local time: 03:19
| Grading comment thanks
4 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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17 mins confidence:   peer agreement (net): +2
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The translation workplace 
