PMID- 30809692 OWN - NLM STAT- MEDLINE DCOM- 20190424 LR - 20191210 IS - 1618-2650 (Electronic) IS - 1618-2642 (Linking) VI - 411 IP - 11 DP - 2019 Apr TI - Measurement of serum progesterone by isotope dilution liquid chromatography tandem mass spectrometry: a candidate reference method and its application to evaluating immunoassays. PG - 2363-2371 LID - 10.1007/s00216-019-01676-7 [doi] AB - Measurement of serum progesterone is important in determining ovarian function. Most progesterone measurements are performed with immunoassays and results are often variable. Standardization of the measurements requires a reliable reference method. An isotope dilution liquid chromatography tandem mass spectrometry (ID-LC/MS/MS) method for the measurement of serum progesterone was developed. Serum samples were spiked with (13)C(3)-progesterone, extracted with a three-step liquid-liquid extraction, and analyzed by LC/MS/MS. A bracketing calibration was used for the analysis and samples were prepared gravimetrically. The developed method showed intra-run and total relative standard deviations (RSDs) of 0.50~0.58% and 0.71~1.33%, respectively. The analytical recoveries were 99.08~101.50%. Measurement results on certified reference materials obtained with this method agreed with the certified values within the stated measurement uncertainties. The method was applied to evaluate immunoassays through split-sample comparisons. A panel of 48 fresh frozen individual samples were measured with the ID-LC/MS/MS method, and six immunoassays and results were compared. Significant calibration biases and sample-specific deviations were observed on some of the immunoassays. FAU - Wang, Yufei AU - Wang Y AD - Graduate School of Peking Union Medical College and Chinese Academy of Medical Sciences, 9 Dongdan Santiao, Beijing, 100730, China. AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. FAU - Zhang, Tianjiao AU - Zhang T AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. FAU - Zhao, Haijian AU - Zhao H AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. FAU - Zhou, Weiyan AU - Zhou W AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. FAU - Zeng, Jie AU - Zeng J AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. FAU - Zhang, Jiangtao AU - Zhang J AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. FAU - Zhang, Chuanbao AU - Zhang C AD - Graduate School of Peking Union Medical College and Chinese Academy of Medical Sciences, 9 Dongdan Santiao, Beijing, 100730, China. cbzhang@nccl.org.cn. AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. cbzhang@nccl.org.cn. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. cbzhang@nccl.org.cn. FAU - Chen, Wenxiang AU - Chen W AD - Graduate School of Peking Union Medical College and Chinese Academy of Medical Sciences, 9 Dongdan Santiao, Beijing, 100730, China. wxchen@nccl.org.cn. AD - National Center for Clinical Laboratories, Beijing Hospital and National Center of Gerontology, 1 Dahua Road, Beijing, 100730, China. wxchen@nccl.org.cn. AD - Beijing Engineering Research Center of Laboratory Medicine, 1 Dahua Road, Beijing, 100730, China. wxchen@nccl.org.cn. LA - eng GR - No. 2011AA02A102/National High Technology Research and Development Program of China/ GR - No. Z161100001816043/The Leaping Development Project of Beijing Biomedical Industry/ PT - Journal Article PT - Validation Study DEP - 20190226 PL - Germany TA - Anal Bioanal Chem JT - Analytical and bioanalytical chemistry JID - 101134327 RN - 4G7DS2Q64Y (Progesterone) SB - IM MH - Calibration MH - Chromatography, High Pressure Liquid/*methods MH - Humans MH - Immunoassay/methods MH - Indicator Dilution Techniques MH - Limit of Detection MH - Progesterone/*blood MH - Reproducibility of Results MH - Tandem Mass Spectrometry/*methods OTO - NOTNLM OT - ID-LC/MS/MS OT - Immunoassays OT - Progesterone OT - Reference method EDAT- 2019/02/28 06:00 MHDA- 2019/04/25 06:00 CRDT- 2019/02/28 06:00 PHST- 2018/11/12 00:00 [received] PHST- 2019/02/06 00:00 [accepted] PHST- 2019/01/26 00:00 [revised] PHST- 2019/02/28 06:00 [pubmed] PHST- 2019/04/25 06:00 [medline] PHST- 2019/02/28 06:00 [entrez] AID - 10.1007/s00216-019-01676-7 [pii] AID - 10.1007/s00216-019-01676-7 [doi] PST - ppublish SO - Anal Bioanal Chem. 2019 Apr;411(11):2363-2371. doi: 10.1007/s00216-019-01676-7. Epub 2019 Feb 26.