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ramesh_7779 ★ 2010-07-15 10:23 (5809 d 12:47 ago) Posting: # 5630 Views: 3,317 |
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Dear All, can any one tell how to fix validity for blood, plasma and serum after collection. if any guidelines availabale please let me know. With Regards Raja |
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Ohlbe ★★★ France, 2010-07-15 12:24 (5809 d 10:47 ago) @ ramesh_7779 Posting: # 5631 Views: 2,768 |
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Dear Raja, Do you mean for study samples, or for blank matrix ? Regards Ohlbe — Regards Ohlbe |
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ramesh_7779 ★ 2010-07-15 13:58 (5809 d 09:12 ago) @ Ohlbe Posting: # 5634 Views: 2,775 |
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Dear Ohlbe, No, its generally for blood, serum and plasma samples. we used get blood, serum and plasma samples from hospitals or from clinical unit for doing method developement and validation, i would like to know how do they fix validity date for the respective samples (i.e. valid upto). Regards Raja |
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paulhurleyuk ☆ NE UK, 2010-07-15 14:46 (5809 d 08:24 ago) @ ramesh_7779 Posting: # 5636 Views: 2,789 |
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❝ i would like to know how do they fix validity date for the respective samples (i.e. valid upto). Typically Analyte Stability in the sample matrix is proven during method validation. Refer to some fo the many guidelines in the guidelines area Validation of Analytical Procedures – Text and Methodology; Q2(R1): step 4, Nov 2005 Concept Paper/Recommendations on the Need for a (CHMP) Guideline on the Validation of Bioanalytical Methods: Dec 2008 (PDF52KB) Validation of Analytical Procedures. Definition and Terminology: Jun 1994 (PDF31KB), Methodology: Jun 1997 (PDF50KB) Bioanalytical Method Validation: May 2001 (PDF63KB) Regards, Paul. |
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Ohlbe ★★★ France, 2010-07-15 17:06 (5809 d 06:04 ago) @ ramesh_7779 Posting: # 5639 Views: 2,747 |
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Dear Raja, If you get blank plasma or blood from a blood bank they have regulations to follow (don't ask me which !) to give an expiry date. Problem: they usually use CPD as anticoagulant, and that's usually not what is used for your study samples. If you collect your blank blood/plasma/serum in-house: I am not aware of any recommendation. Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz