Maria Santes Berto , Sara Sanchez Asis , Juan Robles Bauza , Ana Rubio Alaejos , Josep Miquel Bauça , Jose Antonio Delgado
{"title":"西班牙人口尿液中甲基丙二酸的生物变异。","authors":"Maria Santes Berto , Sara Sanchez Asis , Juan Robles Bauza , Ana Rubio Alaejos , Josep Miquel Bauça , Jose Antonio Delgado","doi":"10.1016/j.cca.2024.119943","DOIUrl":null,"url":null,"abstract":"<div><h3>Background-Aim</h3><p>Methylmalonic acid (MMA) is currently the best biomarker of functional vitamin B12 deficiency. However, for a correct interpretation of the patient’s results it is necessary to know its biological variation (BV).</p><p>No BV data are available for urine MMA values, as measured by mass spectrometry. Hence, the aim of this study was to estimate the within- and between-person coefficients of variation (CV<sub>w,</sub> CV<sub>g</sub>) for MMA in a healthy population, and the associated index of individuality (II), as well as to define quality specifications based on BV and the reference change value (RCV).</p></div><div><h3>Methods</h3><p>Random urine samples from 34 healthy volunteers were collected over four consecutive weeks. Samples were stored at –80 °C until analysis in a single analytical run. MMA excretion was quantified by tandem liquid chromatography coupled to mass spectrometry (HPLC-MS/MS). Results were normalized to urine creatinine.</p><p>The coefficients of variation were estimated by CV-ANOVA. Confidence intervals (95 %) were calculated. Quality specifications were defined according to international recommendations.</p></div><div><h3>Results</h3><p>A total of 128 samples were included. The coefficients of variation were CV<sub>w</sub> = 35.7 % (26.1–45.3) and CV<sub>g</sub> = 67.7 % (58.3–77.0). The associated II was 0.5 and the RCV was 88.1 %.</p></div><div><h3>Conclusion</h3><p>Considering the II obtained, MMA in urine has high individuality, therefore, RCV is better to evaluate serial clinical results. Our results will contribute to a better clinical interpretation of this biomarker and will represent a great aid when defining analytical performance specifications for this magnitude.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2000,"publicationDate":"2024-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Biological variation of methylmalonic acid in urine in spanish population\",\"authors\":\"Maria Santes Berto , Sara Sanchez Asis , Juan Robles Bauza , Ana Rubio Alaejos , Josep Miquel Bauça , Jose Antonio Delgado\",\"doi\":\"10.1016/j.cca.2024.119943\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background-Aim</h3><p>Methylmalonic acid (MMA) is currently the best biomarker of functional vitamin B12 deficiency. However, for a correct interpretation of the patient’s results it is necessary to know its biological variation (BV).</p><p>No BV data are available for urine MMA values, as measured by mass spectrometry. Hence, the aim of this study was to estimate the within- and between-person coefficients of variation (CV<sub>w,</sub> CV<sub>g</sub>) for MMA in a healthy population, and the associated index of individuality (II), as well as to define quality specifications based on BV and the reference change value (RCV).</p></div><div><h3>Methods</h3><p>Random urine samples from 34 healthy volunteers were collected over four consecutive weeks. Samples were stored at –80 °C until analysis in a single analytical run. MMA excretion was quantified by tandem liquid chromatography coupled to mass spectrometry (HPLC-MS/MS). Results were normalized to urine creatinine.</p><p>The coefficients of variation were estimated by CV-ANOVA. Confidence intervals (95 %) were calculated. Quality specifications were defined according to international recommendations.</p></div><div><h3>Results</h3><p>A total of 128 samples were included. The coefficients of variation were CV<sub>w</sub> = 35.7 % (26.1–45.3) and CV<sub>g</sub> = 67.7 % (58.3–77.0). The associated II was 0.5 and the RCV was 88.1 %.</p></div><div><h3>Conclusion</h3><p>Considering the II obtained, MMA in urine has high individuality, therefore, RCV is better to evaluate serial clinical results. Our results will contribute to a better clinical interpretation of this biomarker and will represent a great aid when defining analytical performance specifications for this magnitude.</p></div>\",\"PeriodicalId\":10205,\"journal\":{\"name\":\"Clinica Chimica Acta\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2024-08-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinica Chimica Acta\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S000989812402196X\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S000989812402196X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Biological variation of methylmalonic acid in urine in spanish population
Background-Aim
Methylmalonic acid (MMA) is currently the best biomarker of functional vitamin B12 deficiency. However, for a correct interpretation of the patient’s results it is necessary to know its biological variation (BV).
No BV data are available for urine MMA values, as measured by mass spectrometry. Hence, the aim of this study was to estimate the within- and between-person coefficients of variation (CVw, CVg) for MMA in a healthy population, and the associated index of individuality (II), as well as to define quality specifications based on BV and the reference change value (RCV).
Methods
Random urine samples from 34 healthy volunteers were collected over four consecutive weeks. Samples were stored at –80 °C until analysis in a single analytical run. MMA excretion was quantified by tandem liquid chromatography coupled to mass spectrometry (HPLC-MS/MS). Results were normalized to urine creatinine.
The coefficients of variation were estimated by CV-ANOVA. Confidence intervals (95 %) were calculated. Quality specifications were defined according to international recommendations.
Results
A total of 128 samples were included. The coefficients of variation were CVw = 35.7 % (26.1–45.3) and CVg = 67.7 % (58.3–77.0). The associated II was 0.5 and the RCV was 88.1 %.
Conclusion
Considering the II obtained, MMA in urine has high individuality, therefore, RCV is better to evaluate serial clinical results. Our results will contribute to a better clinical interpretation of this biomarker and will represent a great aid when defining analytical performance specifications for this magnitude.
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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