供应美国NIST-SRM1951C临床检验材料冷冻人血清中的脂质标准物质

供应美国NIST-SRM1951C临床检验材料冷冻人血清中的脂质标准物质

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This Standard Reference Material (SRM) is intended primarily for use in evaluating the accuracy of clinical procedures for the determination of total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol, and total glycerides in human serum. It is also intended for use in validating working or secondary reference materials.

A unit of SRM 1951c consists of four vials of frozen human serum, two vials each at two different analyte concentration levels. Each bottle contains approximately 1 mL of serum. NIST-SRM1951C

A NIST certified value is a value for which NIST has the highest confidence in its accuracy in that all known or suspected sources of bias have been investigated or taken into account [1]. Values for total cholesterol and total glycerides are based upon the means of the results from analyses at NIST and CDC using ID-GC-MS. The uncertainty provided with each certified value is an expanded uncertainty about the mean to cover the measurand with approximately 95 % confidence; it incorporates Type B uncertainty components related to the analyses and expresses both the observed difference between the results from the methods and their respective uncertainties, consistent with the ISO/JCGM Guides [2,3]. The expanded uncertainty is calculated as U = kuc, where uc is the combined uncertainty and k is a coverage factor corresponding to approximately 95 % confidence for each analyte [2]. For the certified values shown in Table 1, k = 2. The measurand is concentration value for each analyte listed in Table 1. Metrological traceability is to the SI derived unit for amount-of-substance concentration (expressed as millimoles per liter) and mass concentration (expressed as milligrams per deciliter). The certified values were determined at NIST and at the Lipid Reference Laboratory at the Centers for Disease Control and Prevention (CDC) by isotope dilution gas chromatography–mass spectrometry (ID-GC-MS) [4–7]. The methods used by NIST and CDC for measurement of total cholesterol and by NIST for measurement of total glycerides are recognized as higher-order reference measurement procedures by the Joint Committee for Traceability in Laboratory Medicine (JCTLM) [8]. The certified concentrations apply only to serum thawed to room temperature, 20 °C to 25 °C (see “Storage” and “Use”). 临床检验材料冷冻人血清中的脂质标准物质

本标准参考物质(SRM)主要用于评估临床程序测定人类血清中总胆固醇、高密度脂蛋白(HDL)-胆固醇、低密度脂蛋白-胆固醇和总甘油酯的准确性。它也用于验证工作或二次参考材料。

SRM 1951c的一个单元由四瓶冷冻人血清组成,每瓶两种不同的分析物浓度。每个瓶子含有大约1毫升血清。

NIST认证值是指NIST对其准确性具有最高信心的值,因为所有已知或怀疑的偏差源都已被调查或考虑[1]。总胆固醇和总甘油酯的值基于NIST和CDC使用ID-GC-MS进行分析的结果平均值。每个认证值提供的不确定度是关于平均值的扩展不确定度,以覆盖具有大约95%置信度的被测量;它包含了与分析相关的B类不确定度分量,并表达了方法结果之间观察到的差异及其各自的不确定度,符合ISO/JCGM指南[2,3]。扩展不确定度计算为U=kuc,其中uc是组合不确定度,k是对应于每个分析物约95%置信度的覆盖因子[2]。对于表1中所示的认证值,k=2。被测物是表1中列出的每种分析物的浓度值。计量可追溯性是指物质浓度(以毫摩尔/升表示)和质量浓度(以毫克/分升表示)的国际单位制衍生单位。NIST和美国疾病控制与预防中心(CDC)的脂质参考实验室通过同位素稀释气相色谱-质谱法(ID-GC-MS)确定了认证值[4-7]。NIST和CDC用于测量总胆固醇的方法以及NIST用于测量总甘油酯的方法被实验室医学可追溯性联合委员会(JCTLM)认定为高阶参考测量程序[8]。认证浓度仅适用于解冻至室温20°C至25°C的血清(见“储存”和“使用”)。