BCR-575

CREATININE IN HUMAN SERUM

1) If the material is reconstituted acording to the specified procedure (see overleaf).

2) This value is the unweighted mean of p accepted mean values independently obtaineded by p laboratories. The value was obtained by different laboratories using in total two independent methods of determination. The values are traceable to the international system of units (SI).

3) Estimated expanded uncertainty U with a coverage factor k = 2. corresponding to a level of confidence of about
95 %, as defined in the Guide to the Expression of Uncertainty in Measurement (GUM), ISO, 1995 indluding contributions from the value assignment and the calibrator.

This certificate is valid for one year after purchase.

The minimum amount of sample to be used is not critical as the sample can be regarded as homogeneous solution after reconstitution (see overleaf).

NOTE

This material has been certified by BCR (Community Bureau of Reference, the former reference materials programme of the European Commission). The certificate has been revised under the responsibility of IRMM.

WARNING

The material has been tested and was found negative for HBsAG, HIV 1+2 antibodies and syphilis antibodies. However, the product must be handled as if infectious. It is intended for in vitro analysis only.

DESCRIPTION OF THE SAMPLE

Each sample is the lyophilized form of approximately 1 mL portion of serum, without any additives.

The mass of the lyophilized material contained in the ampoule is about 0.09 g.

The material is kept under nitrogen in sealed glass ampoules. The water mass fraction of the sample is about 0.2 %.

ANALYTICAL METHODS USED FOR CERTIFICATION

Isotope dilutin gas chromatography mass spectrometry, high perfomance liquid chromatography.

PARTICIPANTS

- Academic Hospital Dijkzigt, Rotterdam (NL)

-Addenbrookes Hospital Cambridge (UK)

- Hopital Necker -Enfants Malades, Paris (FR)

- Hospital Gral. Vall d'Hebron, Barcelona (ES)

- Institut fur Standardisierung und Dokumentation im Medizinischen Laboratorium e.V,Dusseldorf (DE)

-Istituto Scientifico San Raffaele, Milano (IT)

- Medizinische Hochschule Hannover, Abt. Klinische Chemie I, Hannover (DE)

- National Institute for Biological Standards and Control (NIBSC) (UK)

- Plasma Dienst GmbH, Offenbach (DE)

- Referenzinstitut fir Bioanalyse der Deutschen Gesellschaft fur Klinische Chemie e.V.,Institut fur Klinische Biochemie der Universitat Bonn (DE)

-Universiteit Gent, Gent (BE)

SAFETY INFORMATION

The product must be handled as if infectious.

INSTRUCTIONS FOR USE

The material is intended for assessing the accuracy of routine methods and studying of transferability of reference measurement procedures.

For long term storage it is advised to store the sample at - 20 °C until use. To prepare it for use, the material to be reconstituted according to the following procedure.

1. Allow ampoule to reach ambient temperature.

2. Centrifuge the ampoule to collect all lyophilised material on the bottom.

3. Score the ampoule at the constriction with a sharp file and open, by applying a red hot glass rod to the score for about 1 s, while holding the ampoule almost horizontally to prevent glass from entering the ampoule.

4. Reconstitute by slow addition of 1.000 mL distilled water (20。C - 22 °C) to the sides of the ampoule using calibrated glassware or a dispenser of equivalent accuracy. The volume of water must not exceed土0.003 mL when the material is used for transferability studies of reference measurement procedures. When used for the assessment of routine measurement procedures the added volume should not deviate by more than 0.01 mL.

5. Seal the ampoule with an inert plastic flm, invert several times and mix contents by gently swirling. Allow to stand for 20 min. Swirl ampoule again and let stand for 10 min. Total reconstitution time is approximately 45 min.

STORAGE

The material should be stored at - 20 °C. However, the European Commission cannot be held responsible for changes that happen during storage of the material at the customer's premises, especially of opened samples.

Once reconstituted the sample should be used within 8 hours and should not be stored for re-use.

LEGAL NOTICE

Neither IRMM, its subsidiaries, its contractors nor any person acting on their behalf.

(a) make any warranty or representation, express or implied that the use of any information,material, apparatus, method or process disclosed in this document does not infringe any privately owned intellectual property rights; or

(b) assume any liability with respect to, or for damages resulting from, the use of any information, material, apparatus, method or process disclosed in this document save for loss or damage arising solely and directly from the negligence of IRMM or any of its subsidiaries.

注：以上信息仅供参考，以产品附带证书为准。