Reference materials blood

There are also RMs which are prepared for a specific application and are used for validation of relevant methods. Cobbaert et al. (1999) made use of Ion Selective Electrode (ISE)-protein-based materials when evaluating a procedure which used an electrode with an enzyme-linked biosensor to determine glucose and lactate in blood. Chance et al. (1999) are involved with the diagnosis of inherited disorders in newborn children and they prepared a series of reference materials consisting of blood spotted onto filter paper and dried, from which amino-acids can be eluted and... 

Braithwaite RA, Girling AJ (1988) Bovine reference materials for accuracy control of blood lead analysis. Fresenius Z Anal Chem 332 704-709. 

Chance DH, Adam BW, Smith SJ, Alexander JR, Hillman SL, Hannon WH (1999) Validation of accuracy-based amino acid reference materials in dried-blood spots by tandem mass spectrometry for newborn screening assays. Clin Chem 45 1269-1277. 

Common technical specifications (CTS) are to be adopted by the Article 7.2 Committee (a working group of scientific experts appointed by the Member States) which will apply to devices in Annex II List A and, when required, devices in Annex II List B. There is some uncertainty about the circumstances in which the requirement might apply to List B devices. CTS establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods, and reference materials. If, for duly justified reasons, manufacturers do not comply with the CTS, they must adopt other solutions which are at least equivalent to these specifications. CTS are intended mainly for the evaluation of the safety of the blood supply and organ donations. 

Accurate determination of the biological important element, selenium, in blood serum by isotope dilution analysis using ICP-QMS with octopole collision cell (Agilent 7500ce, Tokio, Japan) is described by Schaumloffel and coworkers.55 A recovery of selenium from human serum reference material was only 78 % when hydrogen was applied as collision gas but 96.7 % using xenon as a non-reactive collision gas to eliminate isobaric interferences. A detection limit of 3.3p,gl-1 was achieved.55... 

Specifications could include required accuracy and precision, reagent purity, tolerances for apparatus, the use of Standard Reference Materials, and acceptable values for blanks. Standard Reference Materials (Box 3-1) contain certified levels of analyte in realistic materials that you might be analyzing, such as blood or coal or metal alloys. Your analytical method should produce an answer acceptably close to the certified level or there is something wrong with the accuracy of your method. 

It is relevant to ask how often the routine measurement procedures currently used in laboratory medicine provide results that are traceable to high-level calibrators and reference measurement procedures (Lequin personal communication). It turns out that primary reference measurement procedures and primary calibrators are only available for about 30 types of quantity such as blood plasma concentration of bilirubins, cholesterols and sodium ion. International reference measurement procedures from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and corresponding certified reference material from BCR are available for the catalytic activity concentration of a few enzymes such as alkaline phosphatase and creatine kinase in plasma. For another 25 types of quantity, such... 

More than 220 producers of CRMs throughout the world produce today 12,000 20,000 materials with dif ferent matrixes, analytes and properties [4]. However, many testing (analytical) laboratories cannot find suitable CRMs in the market and develop in-house reference materials (IHRMs) themselves. Often IHRMs are developed in a laboratory to conserve the corresponding expensive CRMs. For example, a pharmaceutical company Chemagis Ltd. produces 30 active pharmaceutical ingredients steroids, benzodiazepines, antihistamines, hipolipidaemics, blood flow reactants, etc. Only for a few of them Mo-metasone Furoate, Fluticasone Propionate and Dobutamine Hydrochloride are of fi-cial reference standards for assay supplied by US, British and European Pharmacopoeias with prices of about 180 per unit (50 200 mg). Thus, to support its customers Chemagis is forced to develop IHRMs for assay as well as for impurities and related substances of each produced compound. Therefore, certification of such IHRMs that leads to traceable values is very important. 

Reference interval Data applicable for the sample material blood, serum and plasma... 

The concentration of a solute in a solution may be expressed in different ways (Table 1-1). In the United States, laboratory data typically are reported in terms of mass of solute per unit volume of solution, usually the deciliter. However, the Systeme International d Unit s (SI) recommends the use of moles of solute per volume of solution for analyte concentrations (substance concentrations), whenever possible, and the use of liter as the reference volume. Although considered incorrect and inappropriate by metrologists, mass concentration also is reported in terms of grams percent or percent. This is typically how concentrations of ethanol in blood are expressed. This terminology indicates an amount of solute per mass of solution (e.g., grams per 100 g) and would be appropriate only if reference materials against which the unknowns were compared were also measured in the same terms. An exception to the general expression of analyte con-... 

International Federation of Clinical Chemistry, Committee on pH, Blood Gases and Electrolytes An Approved IFCC Recommendation. IFCC method (1988) for tonometry of blood Reference materials for PCO2 and PO2. Clin Chim Acta 1989 185 ... 

Maas AH. IFCC reference methods for measurement of pH, gases and electrolytes in blood Reference materials. Eur J Clin Chem Clin Biochem 1991 29 253-61. 

The standards for bioequivalence are similar worldwide, but as a specimen we can use the Code of Federal Regulations, Title 21 (21CFR), parts 320.1-320.63) in the United States. The regulation states that bioequivalence is .. demon-demonstrated if the product s rate and extent of absorption, as determined by comparison of measured parameters, for example concentration of active drug ingredient in the blood, urinary excretion rates, or pharmacological effects, do not indicate a significant difference from the reference material s rate and extent of absorption . 

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