S-Monovette® HCY-C Evaluation Report Prepared by: SARSTEDT AG & Co. Hyperhomocysteinaemia has been established as an important, independent risk factor for atherosclerotic and neurodegenerative diseases. Fig. 1: tHCY recovery in EDTA blood when stored at room temperature n = 11 donors, with simple standard deviation % recovery For diagnostic purposes, the total homocysteine concentration (tHCY) in the blood plasma is determined. During this procedure, compliance with preanalytical requirements is imperative because, even after blood collection, homocysteine is continually exported from the erothrocytes into the plasma. Specialist medical literature1 indicates an increase of approximately 10 % per hour. This fact has been substantiated in in-house tests (FPIA, Abbott IMx): The new S-Monovette® HCY-C (Art. No. 04.1911.001) with Acidic Citrate Solution (pH 4.3) now enables stabilization of homocysteine concentration in the blood sample. Blood collection is carried out to the well-tried and reliable S-Monovette® principle. For preparatory reasons, the raw measuring value established after analysis must be multiplied by the dilution factor 1.11 in order to obtain the diagnostic homocysteine value. Fig. 2: tHCY recovery in Acidic Citrate Blood when stored at room temperature n = 13 donors, with simple standard deviation % recovery According to specialized medical literature2, this citrate solution stabilizes the homocysteine value for 6 hours at room temperature. This fact, too, has been verified in internal tests (FPIA, Abbott IMx): Fig. 3: tHCY recovery in Acidic Citrate Blood when stored at 4 °C n = 10 donors, with simple standard deviation % recovery It is also known that sample storage at 4 °C stabilizes the homocysteine values in Acidic Citrate Blood for 48 hours: Fig. 4: tHCY recovery in Acidic Citrate Blood when first stored at room temperature for 6 hours and later on at 4°C n = 13 donors, with simple standard deviation % recovery This can also be confirmed if the samples are first stored at room temperature and later on kept in a refrigerated environment at 4 °C: List of References: 1 A. Andersson, A. Isaksson and B. Hultberg: Homocysteine Export from Erythrocytes and its Implication for Plasma Sampling Clin Chem 1992, 38, 1311-1315. P. Ueland, H. Refsum, S. P. Stabler, M. R. Malinow, A. Andersson and R. H. Allen: Total Homocysteine in Plasma or Serum: Methods and Clinical Applications Clin Chem 1993, 39, 1764-1779. 2 H. P. J. Willems, G. M. J. Bos, W. B. J. Gerrit, M. den Heijer, S. Vloet and H. J. Blom: Acidic Citrate Stabilizes Blood Samples for Assay of Total Homocysteine Clin Chem 1998, 44, 342-345. M. Nauck, E. Bisse and H. Wieland: Pre-analytical Conditions Affecting the Determination of the Plasma Homocysteine Concentration Clin Chem Lab Med 2001, 39, 675-680. H. P. J. Willems, M. den Heijer, J. Lindemans, H. W. A. Berenschot, W. B. J. Gerrits, G. M. J. Bos, H. J. Blom: Measurement of Total Homocysteine Concentrations in Acidic Citrate- and EDTA-Containing Tubes by Different Methods Clin Chem 2004, 50, 1881-1883. 422a-200-0106-0909 This document may contain information on products that may not be available in particular countries Technical modifications reserved Measurement of homocysteine values (in μmol/L) from S-Monovette® HCY-C (0 and 6 h at room temperature) vs. S-Monovette® EDTA (0 h, x-axis) in an instrument comparison of IMx (Abbott), AxSYM (Abbott), Synchron (Beckmann Coulter) and Immulite 2000 (DPC): methodical ± 3s precision range as specified by the instrument manufacturers (Inter-Assay) HCY-C 0 h with straight regression line HCY-C 6 h with straight regression line SARSTEDT AG & Co. P.O. Box 12 20 D-51582 Nümbrecht Phone +49 2293 3050 Fax +49 2293 305- 122 [email protected] www.sarstedt.com
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