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Abstract

This report describes the processing and certification of BCR-348R, a reference material for endogenous progesterone at a level of approximately 8 µgl/L in human serum. The material is lyophilised and kept in glass ampoules. The material has been shown to be homogeneous and stable on storage at -20 °C for 24 months.
The mass concentration of progesterone in the reconstituted BCR-348R sample is certified to a value of 8.5 µg/L (26.9 nmol/L) with an expanded standard uncertainty value (UCRM) of 0.4 µg/L (1.2 nmol/L) (k = 2). The measurement procedure used for characterisation was based on ID-GC-MS (Gas Chromatography-Isotope Dilution-Mass Spectrometry).
The reference material is intended to be used for accuracy assessment and quality control of progesterone measurement procedures using ID-GC-MS and verify the comparability of results from different laboratories using that technique. The material can also be used for calibration or quality control of in vitro diagnostic devices if commutability of this material has been demonstrated using ID-GC-MS reference method for comparison.

Additional information

Authors: EMONS H, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);TOUSSAINT B, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);KLEIN C L, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);FRANCHINI F, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);SCHIMMEL H, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE)
Bibliographic Reference: EUR 22299 EN (2006), 40 pp. Free of charge
Availability: Available from European Commission, JRC Knowledge Management Unit, Ispra (IT) Tel: +39 033278 9893 Fax: +39 033278 5409 E-mail: jrc-publications-office@ec.europa.eu or Bruxelles (BE) Tel: +32 2 295 76 24 Fax: +32 2 299 63 22
ISBN: ISBN: 92-79-02460-4
Record Number: 200618673 / Last updated on: 2006-08-11
Category: PUBLICATION
Original language: en
Available languages: en
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