期刊
CLINICAL MASS SPECTROMETRY
卷 3, 期 -, 页码 25-38出版社
ELSEVIER
DOI: 10.1016/j.clinms.2017.06.002
关键词
Spontaneous preterm birth; Proteomics; Mass spectrometry; Insulin-like growth factor-binding protein 4; Sex hormone-binding globulin; Validation; Clinical
资金
- Sera Prognostics, Inc.
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. (C) 2017 The Authors. Published by Elsevier B.V. on behalf of The Association for Mass Spectrometry: Applications to the Clinical Lab (MSACL). This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
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