采用液相色谱-质谱法评价睾酮、雌二醇和孕酮免疫分析校准品。
Evaluation of testosterone, estradiol and progesterone immunoassay calibrators by liquid chromatography mass spectrometry.
机构信息
ANZAC Research Institute, University of Sydney, Concord, NSW, Australia.
Department of Andrology, Concord Hospital, Concord, NSW 2139, Australia.
出版信息
Clin Chem Lab Med. 2023 Jun 5;61(9):1612-1618. doi: 10.1515/cclm-2022-1179. Print 2023 Aug 28.
OBJECTIVES
In clinical practice, steroid measurements are performed mainly by direct, non-extraction immunoassays adapted to high throughput, automated immunoassay platforms and employing secondary calibrators. The accuracy of such steroid immunoassays is limited by cross-reactivity with structurally related steroids and nonspecific matrix interference as well as the metrological traceability of manufacturer supplied calibrators. The accuracy of steroid immunoassay calibrators has been little investigated by independent chemical methods.
METHODS
Steroid concentrations of 41 calibrators (4-6 replicates per calibrator) supplied by four manufacturers for use in testosterone (T), estradiol (E), and progesterone (P) commercial immunoassays were measured by ultra-pressure liquid chromatography-mass spectrometry (UPLC-MS).
RESULTS
Among 14 non-zero T calibrators, six (43 %) deviated significantly from the label concentration with 29 % outside 20 % of it. Among 14 E calibrators, eight (57 %) deviated significantly, whereas seven (50 %) were outside 20 % of the label concentration. Among 11 P calibrators, eight (73 %) deviated significantly whereas four (36 %) were outside within 20 % of the label concentration.
CONCLUSIONS
We conclude that inaccurate calibration of manufacturer's supplied standards may contribute to inaccuracy of commercial direct steroid immunoassays.
目的
在临床实践中，类固醇的测量主要通过直接、非提取免疫测定法进行，这些方法适用于高通量、自动化免疫测定平台，并采用二级校准品。此类类固醇免疫测定法的准确性受到与结构相关的类固醇的交叉反应、非特异性基质干扰以及制造商提供的校准品的计量溯源性的限制。类固醇免疫测定校准品的准确性很少通过独立的化学方法进行研究。
方法
使用超高效液相色谱-质谱法（UPLC-MS）测量了四个制造商提供的用于睾酮（T）、雌二醇（E）和孕酮（P）商业免疫测定的 41 个校准品（每个校准品 4-6 个重复）的类固醇浓度。
结果
在 14 个非零 T 校准品中，有 6 个（43%）明显偏离标签浓度，其中 29%的浓度偏离标签浓度的 20%。在 14 个 E 校准品中，有 8 个（57%）明显偏离，而 7 个（50%）的浓度偏离标签浓度的 20%。在 11 个 P 校准品中，有 8 个（73%）明显偏离，而 4 个（36%）的浓度偏离标签浓度的 20%。
结论
我们的结论是，制造商提供的标准品校准不准确可能导致商业直接类固醇免疫测定不准确。
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