罗氏 Elecsys 维生素 D3（25-OH）检测法过度报告维生素 D 缺乏症。
Overreporting of vitamin D deficiency with the Roche Elecsys Vitamin D3 (25-OH) method.
机构信息
Clinical Biochemistry Unit, Alfred Pathology Service, Melbourne,Victoria, Australia.
出版信息
Pathology. 2011 Jun;43(4):368-71. doi: 10.1097/PAT.0b013e328346431c.
BACKGROUND
Vitamin D deficiency is common. Recently Roche Diagnostics removed their Elecsys Vitamin D3 (25OH) electrochemiluminescence immunoassay (ECLIA) from use, citing deteriorating traceability to the reference method (liquid chromatography tandem mass spectrometry; LCMSMS). We investigated the performance of the Roche assay (2 assay formulations) against an LCMSMS method and the widely used DiaSorin radioimmunoassay (RIA) method.
METHODS
Two sets of samples from separate populations were assayed for vitamin D. The first set was assayed using three different methods: RIA (DiaSorin) in 2004, polyclonal ECLIA (Roche) in early 2009 and LCMSMS in early 2010. The second set was assayed using polyclonal and monoclonal ECLIA (Roche) and LCMSMS in mid-2010.
RESULTS
The correlation of the polyclonal ECLIA with the RIA was poor (ECLIA = 0.45 × RIA + 19, r(2) = 0.59, n = 773). LCMSMS results correlated with RIA (RIA = 0.86 × LCMSMS + 4, r(2) = 0.69, n = 49) better than with polyclonal ECLIA (polyclonal ECLIA = 0.55 × LCMSMS + 6, r(2) = 0.62, n = 55) despite a storage interval of 6 years.In recently collected samples monoclonal and polyclonal immunoassays gave similar results (monoclonal ECLIA = 0.93 polyclonal ECLIA -3, r(2) = 0.60, n = 153). The correlation between monoclonal Roche ECLIA and LCMSMS in these samples was very poor (monoclonal ECLIA = 0.31 × LCMSMS + 23, r(2) = 0.27).
CONCLUSIONS
At the time of its removal from the market, the Roche Elecsys Vitamin D3 (25OH) assay showed unacceptable performance, underestimating vitamin D levels. It seems that this bias preceded the introduction of the monoclonal assay. The worldwide distribution of the assay and the duration of this bias likely led to a significant number of patients starting supplementation unnecessarily.
背景
维生素 D 缺乏很常见。罗氏诊断公司最近停用了他们的 Elecsys 维生素 D3（25OH）电化学发光免疫分析（ECLIA），理由是与参考方法（液相色谱串联质谱法；LCMSMS）的溯源性恶化。我们研究了罗氏检测方法（2 种检测配方）与广泛使用的 DiaSorin 放射免疫分析（RIA）方法的对比性能。
方法
从两个不同人群的样本中分别检测维生素 D。第一组样本使用三种不同的方法进行检测：2004 年使用 RIA（DiaSorin），2009 年初使用多克隆 ECLIA（罗氏），2010 年初使用 LCMSMS。第二组样本使用多克隆和单克隆 ECLIA（罗氏）以及 2010 年中使用 LCMSMS 进行检测。
结果
多克隆 ECLIA 与 RIA 的相关性较差（ECLIA = 0.45 × RIA + 19，r² = 0.59，n = 773）。LCMSMS 结果与 RIA 的相关性更好（RIA = 0.86 × LCMSMS + 4，r² = 0.69，n = 49），与多克隆 ECLIA 的相关性更好（多克隆 ECLIA = 0.55 × LCMSMS + 6，r² = 0.62，n = 55），尽管存在 6 年的储存间隔。在最近收集的样本中，单克隆和多克隆免疫测定给出了相似的结果（单克隆 ECLIA = 0.93 多克隆 ECLIA -3，r² = 0.60，n = 153）。在这些样本中，罗氏单克隆 ECLIA 与 LCMSMS 之间的相关性非常差（单克隆 ECLIA = 0.31 × LCMSMS + 23，r² = 0.27）。
结论
在罗氏 Elecsys 维生素 D3（25OH）检测方法从市场上撤出时，其性能表现不佳，低估了维生素 D 水平。这种偏差似乎先于单克隆检测方法的引入。该检测方法在全球范围内的分布以及这种偏差的持续时间可能导致大量患者不必要地开始补充维生素。
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