用可互换的控制材料进行校准，能够降低当前用于测定 HbA 的高性能方法之间的方法间差异。

Calibration by commutable control materials is able to reduce inter-method differences of current high-performance methods for HbA.

机构信息

Dip. di Fisiopatologia Medico-Chirurgica e dei Trapianti, Centro per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Università degli Studi di Milano, Milano, Italy.

Clincal Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

出版信息

Clin Chim Acta. 2018 Feb;477:60-65. doi: 10.1016/j.cca.2017.12.001. Epub 2017 Dec 5.

DOI:10.1016/j.cca.2017.12.001

PMID:29203428

Abstract

BACKGROUND

Most of the current methods used for the determination of HbA seem not well aligned. A comparison among the best performing techniques and the commutability of some control materials currently available and under development has been evaluated.

METHODS

Forty blood samples were analyzed in duplicate over two separate days by different HPLC and capillary electrophoresis systems. The commutabilities of different control materials (NIBSC WHO reagent, Bio-Rad Lyphochek, and home prepared lyophilized controls RP1-3) have been assessed by analyzing the controls in quadruplicate over two consecutive days together with the blood samples.

RESULTS

The mean within-run imprecision of HbA measurement on blood samples (CV, %) was between 0.6% and 10.1% for HbA values <3.5%, and between 1.1 and 3.1 for HbA≥3.5%. The different methods were highly correlated (r between 0.9941 and 0.9995) although biased each other. The NIBSC WHO reagent was found not commutable in 15 over 28 comparisons, the Lyphochek 2 in 18/28, and RP3 in 4/28. Recalibration of all methods by RP1 and RP2 materials was able to reduce the overall variability from 6.8% to 3.4% at HbA≤3.0% and from 6.7% to 3.0% at HbA≥4.6%.

CONCLUSION

The use of adequate commutable control materials as calibrators may reduce the inter-method variability of routine methods to an extent closer to the current analytical goals of bias based on biological variability.

摘要

背景

目前用于测定 HbA 的大多数方法似乎不太一致。评估了最佳性能技术之间的比较，以及当前可用和正在开发的一些控制材料的互换性。

方法

在两天内，通过不同的 HPLC 和毛细管电泳系统对 40 份血样进行了重复分析。通过在两天内对控制材料（NIBSC WHO 试剂、Bio-Rad Lyphochek 和自制冻干对照品 RP1-3）进行四倍重复分析，评估了不同控制材料的可互换性，并与血样一起进行分析。

结果

在血液样本中，HbA 测量的日内精密度（%）的平均值（CV）对于<3.5%的 HbA 值为 0.6%至 10.1%，对于 HbA≥3.5%为 1.1%至 3.1%。不同的方法高度相关（r 值在 0.9941 和 0.9995 之间），尽管彼此存在偏差。在 28 次比较中有 15 次发现 NIBSC WHO 试剂不可互换，Lyphochek 2 有 18/28 次，RP3 有 4/28 次。通过 RP1 和 RP2 材料对所有方法进行重新校准，可以将整体变异性从 HbA≤3.0%时的 6.8%降低到 3.4%，从 HbA≥4.6%时的 6.7%降低到 3.0%。