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用于自发性早产风险的蛋白质生物标志物的分析验证

Analytical validation of protein biomarkers for risk of spontaneous preterm birth.

作者信息

Bradford Chad, Severinsen Rob, Pugmire Trina, Rasmussen Matison, Stoddard Kathryn, Uemura Yuta, Wheelwright Spencer, Mentinova Marija, Chelsky Daniel, Hunsucker Stephen W, Kearney Paul, Hickok Durlin, Fleischer Tracey C, Ichetovkin Ilia, Boniface J Jay, Critchfield Gregory C, Peltier John M

机构信息

Sera Prognostics, Inc., 2749 East Parleys Way, Suite 200, Salt Lake City, UT 84109, USA.

Caprion Biosciences, 201 Avenue Président Kennedy, Suite 3900, Montréal, Québec H2X 3Y7, Canada.

出版信息

Clin Mass Spectrom. 2017 Jun 12;3:25-38. doi: 10.1016/j.clinms.2017.06.002. eCollection 2017 Jan.

DOI:10.1016/j.clinms.2017.06.002
PMID:39193098
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11322780/
Abstract

Presented are the validation results of a second-generation assay for determining the relative abundances of two protein biomarkers found in maternal serum that predict an individual's risk of spontaneous preterm birth. The sample preparation workflow is complex, consisting of immuno-depletion of high-abundance serum proteins, tryptic digestion of the immuno-depleted fraction to generate surrogate peptide analytes, and detection by tandem mass spectrometry. The method was determined to be robust on observation of the following characteristics: classifier peptide detection precision was excellent; results were accurate when compared to a reference method; results were linear over a clinically relevant range; the limits of quantitation encompassed the range of expected results; and the method demonstrated analytical specificity and resilience to differences in patient serum and common endogenous interferents.

摘要

本文展示了一种第二代检测方法的验证结果，该方法用于测定母体血清中发现的两种蛋白质生物标志物的相对丰度，这两种生物标志物可预测个体自发性早产的风险。样品制备流程复杂，包括对高丰度血清蛋白进行免疫去除、对免疫去除后的部分进行胰蛋白酶消化以生成替代肽分析物，以及通过串联质谱进行检测。通过观察以下特征确定该方法具有稳健性：分类肽检测精度极佳；与参考方法相比结果准确；在临床相关范围内结果呈线性；定量限涵盖预期结果范围；并且该方法显示出分析特异性以及对患者血清差异和常见内源性干扰物的耐受性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/b6106573e470/gr12.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/df36866532c3/gr4.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/36100f08ab1d/gr8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/3443be8bb204/gr9.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/ea41a654212a/gr10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/1edbea1b909b/gr11.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/b6106573e470/gr12.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/c650a541a816/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/e7b8bb09b86b/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/07c60e71d506/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/df36866532c3/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/b22267392da2/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/6d66c1b8355c/gr6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/1fa1a06e6e2b/gr7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/36100f08ab1d/gr8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/3443be8bb204/gr9.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/ea41a654212a/gr10.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/1edbea1b909b/gr11.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de3f/11322780/b6106573e470/gr12.jpg

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本文引用的文献

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Am J Obstet Gynecol. 2016 May;214(5):633.e1-633.e24. doi: 10.1016/j.ajog.2016.02.001. Epub 2016 Feb 11.
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An integrated quantification method to increase the precision, robustness, and resolution of protein measurement in human plasma samples.一种集成的定量方法，可提高人血浆样品中蛋白质测量的精度、稳健性和分辨率。
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Quantification of a proteotypic peptide from protein C inhibitor by liquid chromatography-free SISCAPA-MALDI mass spectrometry: application to identification of recurrence of prostate cancer.应用免液相色谱 SISCAPA-MALDI 质谱法对蛋白 C 抑制剂的标志性肽进行定量分析：用于前列腺癌复发的鉴定。
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Measurement of thyroglobulin by liquid chromatography-tandem mass spectrometry in serum and plasma in the presence of antithyroglobulin autoantibodies.在存在抗甲状腺球蛋白自身抗体的情况下，通过液相色谱-串联质谱法测量血清和血浆中的甲状腺球蛋白。
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