Menghua Rao , Zaixin Guo , Heng Dong , Chung Shun Ho , Xiuru Chen , Jin Li , Xinyu Hong , Yang You , Yanfang Hao , Pan Hu , Xuhui She , Qi Yu
{"title":"LC-MS/MS计算和快速平衡透析人血清游离睾酮及其在PCOS诊断中的作用。","authors":"Menghua Rao , Zaixin Guo , Heng Dong , Chung Shun Ho , Xiuru Chen , Jin Li , Xinyu Hong , Yang You , Yanfang Hao , Pan Hu , Xuhui She , Qi Yu","doi":"10.1016/j.cca.2025.120210","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>To compare the calculated and the rapid equilibrium dialyzed (ED) human serum free testosterone (FT) by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and to explore their performances in polycystic ovary syndrome (PCOS) diagnosis.</div></div><div><h3>Methods</h3><div>A rapid ED LC-MS/MS method for serum FT was established and validated for linearity, lower limit of the measuring interval (LLMI), imprecision, trueness, stability, dilution, matrix specificity and carryover. The validated ED LC-MS/MS (ED-FT) was compared with calculated LC-MS/MS method from Vermeulen’s formula (cFT) for FT measurement in 139 PCOS patients and 100 healthy controls. The performances of total testosterone (TT), ED-FT and cFT by LC-MS/MS in PCOS diagnosis were investigated with the same cohorts.</div></div><div><h3>Results</h3><div>The linearity range of ED-FT was 1.74–890 pmol/L, with a LLMI at 1.74 pmol/L. The intra-assay and inter-assay imprecision were < 3.8 % and < 5.9 %. The trueness was acceptable with recoveries of 92.9 %-108.2 %. The equilibrium dialysis time was 4 h. The two FT methods displayed systematic and proportional differences and cFT showed significant positive deviations compared to ED-FT. Receiver operating characteristic curve analysis proved that ED-FT outperformanced in PCOS diagnosis with the an area under the curve at 0.973, sensitivity of 89.93 % and specificity of 96.00 %.</div></div><div><h3>Conclusions</h3><div>This study established a rapid, accurate and sensitive ED LC-MS/MS method for serum FT. ED-FT is optimal compared to TT and cFT by LC-MS/MS in PCOS diagnosis.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120210"},"PeriodicalIF":2.9000,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The calculated and the rapid equilibrium dialyzed human serum free testosterone by LC-MS/MS and their performances in PCOS diagnosis\",\"authors\":\"Menghua Rao , Zaixin Guo , Heng Dong , Chung Shun Ho , Xiuru Chen , Jin Li , Xinyu Hong , Yang You , Yanfang Hao , Pan Hu , Xuhui She , Qi Yu\",\"doi\":\"10.1016/j.cca.2025.120210\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>To compare the calculated and the rapid equilibrium dialyzed (ED) human serum free testosterone (FT) by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and to explore their performances in polycystic ovary syndrome (PCOS) diagnosis.</div></div><div><h3>Methods</h3><div>A rapid ED LC-MS/MS method for serum FT was established and validated for linearity, lower limit of the measuring interval (LLMI), imprecision, trueness, stability, dilution, matrix specificity and carryover. The validated ED LC-MS/MS (ED-FT) was compared with calculated LC-MS/MS method from Vermeulen’s formula (cFT) for FT measurement in 139 PCOS patients and 100 healthy controls. The performances of total testosterone (TT), ED-FT and cFT by LC-MS/MS in PCOS diagnosis were investigated with the same cohorts.</div></div><div><h3>Results</h3><div>The linearity range of ED-FT was 1.74–890 pmol/L, with a LLMI at 1.74 pmol/L. The intra-assay and inter-assay imprecision were < 3.8 % and < 5.9 %. The trueness was acceptable with recoveries of 92.9 %-108.2 %. The equilibrium dialysis time was 4 h. The two FT methods displayed systematic and proportional differences and cFT showed significant positive deviations compared to ED-FT. Receiver operating characteristic curve analysis proved that ED-FT outperformanced in PCOS diagnosis with the an area under the curve at 0.973, sensitivity of 89.93 % and specificity of 96.00 %.</div></div><div><h3>Conclusions</h3><div>This study established a rapid, accurate and sensitive ED LC-MS/MS method for serum FT. 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The calculated and the rapid equilibrium dialyzed human serum free testosterone by LC-MS/MS and their performances in PCOS diagnosis
Objective
To compare the calculated and the rapid equilibrium dialyzed (ED) human serum free testosterone (FT) by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and to explore their performances in polycystic ovary syndrome (PCOS) diagnosis.
Methods
A rapid ED LC-MS/MS method for serum FT was established and validated for linearity, lower limit of the measuring interval (LLMI), imprecision, trueness, stability, dilution, matrix specificity and carryover. The validated ED LC-MS/MS (ED-FT) was compared with calculated LC-MS/MS method from Vermeulen’s formula (cFT) for FT measurement in 139 PCOS patients and 100 healthy controls. The performances of total testosterone (TT), ED-FT and cFT by LC-MS/MS in PCOS diagnosis were investigated with the same cohorts.
Results
The linearity range of ED-FT was 1.74–890 pmol/L, with a LLMI at 1.74 pmol/L. The intra-assay and inter-assay imprecision were < 3.8 % and < 5.9 %. The trueness was acceptable with recoveries of 92.9 %-108.2 %. The equilibrium dialysis time was 4 h. The two FT methods displayed systematic and proportional differences and cFT showed significant positive deviations compared to ED-FT. Receiver operating characteristic curve analysis proved that ED-FT outperformanced in PCOS diagnosis with the an area under the curve at 0.973, sensitivity of 89.93 % and specificity of 96.00 %.
Conclusions
This study established a rapid, accurate and sensitive ED LC-MS/MS method for serum FT. ED-FT is optimal compared to TT and cFT by LC-MS/MS in PCOS diagnosis.
期刊介绍：
The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells.
The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.
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