6.2.4 A Nordic Reference Serum Suitable for Use as Trueness Control in the Clinical Routine Laboratory

Autor:	Ilkka Penttilä, Per Hyltoft Petersen, Adam Uldall, Ole Blaabjerg, Willie Gerhardt, Heidi Steensland, Elin Olafsdottir, Kristoffer Hellsing, Peter Elg
Rok vydání:	1993
Předmět:	medicine.medical_specialty Chromatography business.industry General Medicine Clinical routine Ampoule Reference intervals Surgery Reference measurement Cryoprecipitate Biological variation medicine Aseptic processing business Clearance
Zdroj:	Upsala Journal of Medical Sciences. 98:405-412
ISSN:	2000-1967 0300-9734
DOI:	10.3109/03009739309179340
Popis:	The described reference serum is characterized by: liquid human serum at “normal” level stored in frozen state at −80°C; minimum damage of proteins; aseptic preparation; cryoprecipitate and excess fibrin removed; serum cleared by ultracentrifugation; pH at 7.2–7.6; available in sealed glass ampoules with inert gas (one ml serum in each); specified components among most frequently analyzed analytes; homogeneity assured and stability monitored; produced under strict rules for good manufacturing practices (GMP).The assigned values are traceable to reference measurement procedures and reference materials of highest achievable metrological level; according to the present proposal the maximum allowable uncertainty of the assigned value is based on biological variation (shared common reference intervals); the uncertainty should ideally not exceed 1/5 of the maximum allowable bias of results obtained on patients samples (even 1/2 would theoretically be acceptable and, for a practical guide approximately
Databáze:	OpenAIRE
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