{"title":"Validation, performance, and reliability of two automated tests for vitamin B12 and folate assay.","authors":"Simone Bianciardi, Giulia Tesi, Helena Cerutti, Alessandra Cartocci, Roberto Guerranti, Caterina Silvestrini, Sabrina Gori, Tommaso Bandini, Alessandra Brogi, Roberto Leoncini","doi":"10.1177/22799036231217803","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Deficiency of Vitamin B12 and folate may determine hematological, neurological, and metabolic alterations; therefore, an accurate quantification of their serum levels is required, especially in the presence of symptoms that might suggest a deficiency. CHORUS VIT B12 and CHORUS FOLATE are two automated immunoassays, developed to quantify vitamin B12 and folate, respectively, in human serum.</p><p><strong>Design and methods: </strong>This single-center, non-pharmacological, diagnostic study described the validation and characterization of CHORUS VIT B12 and CHORUS FOLATE, with a specific focus on performance, precision, and reliability. For each assay, 500 serum samples were analyzed. A comparison between CHORUS assays and commercially available kit was also performed.</p><p><strong>Results: </strong>For CHORUS VIT B12 the lower limit of quantification (LLoQ) was 165.0 pg/mL and the upper LoQ (ULoQ) was 1846.8 pg/mL. The assay was linear within the calibration range (150-2000 pg/mL) and the accuracy was described with the International Standard Vitamin B12, Serum Folate, HOLO TC (NIBSC code: 03/178), with a mean recovery on two lots of 111%. For CHORUS FOLATE (calibration range of 2.0-20.0 ng/mL), LLoQ was 2.0 ng/mL and ULoQ 19.6 ng/mL. The linearity was demonstrated from 2.4 to 20.0 ng/mL; the accuracy was described with the International Standard mentioned above, achieving a mean recovery on three lots of 92%. The lowest and highest values of both CHORUS and COBAS kits were similar and the median values did not significantly vary.</p><p><strong>Conclusion: </strong>CHORUS VIT B12 and CHORUS FOLATE performed well, accurately, and reliably in quantifying vitamin B12 and folate in human serum.</p>","PeriodicalId":45958,"journal":{"name":"Journal of Public Health Research","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10722937/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Public Health Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/22799036231217803","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/10/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Deficiency of Vitamin B12 and folate may determine hematological, neurological, and metabolic alterations; therefore, an accurate quantification of their serum levels is required, especially in the presence of symptoms that might suggest a deficiency. CHORUS VIT B12 and CHORUS FOLATE are two automated immunoassays, developed to quantify vitamin B12 and folate, respectively, in human serum.
Design and methods: This single-center, non-pharmacological, diagnostic study described the validation and characterization of CHORUS VIT B12 and CHORUS FOLATE, with a specific focus on performance, precision, and reliability. For each assay, 500 serum samples were analyzed. A comparison between CHORUS assays and commercially available kit was also performed.
Results: For CHORUS VIT B12 the lower limit of quantification (LLoQ) was 165.0 pg/mL and the upper LoQ (ULoQ) was 1846.8 pg/mL. The assay was linear within the calibration range (150-2000 pg/mL) and the accuracy was described with the International Standard Vitamin B12, Serum Folate, HOLO TC (NIBSC code: 03/178), with a mean recovery on two lots of 111%. For CHORUS FOLATE (calibration range of 2.0-20.0 ng/mL), LLoQ was 2.0 ng/mL and ULoQ 19.6 ng/mL. The linearity was demonstrated from 2.4 to 20.0 ng/mL; the accuracy was described with the International Standard mentioned above, achieving a mean recovery on three lots of 92%. The lowest and highest values of both CHORUS and COBAS kits were similar and the median values did not significantly vary.
Conclusion: CHORUS VIT B12 and CHORUS FOLATE performed well, accurately, and reliably in quantifying vitamin B12 and folate in human serum.
期刊介绍：
The Journal of Public Health Research (JPHR) is an online Open Access, peer-reviewed journal in the field of public health science. The aim of the journal is to stimulate debate and dissemination of knowledge in the public health field in order to improve efficacy, effectiveness and efficiency of public health interventions to improve health outcomes of populations. This aim can only be achieved by adopting a global and multidisciplinary approach. The Journal of Public Health Research publishes contributions from both the “traditional'' disciplines of public health, including hygiene, epidemiology, health education, environmental health, occupational health, health policy, hospital management, health economics, law and ethics as well as from the area of new health care fields including social science, communication science, eHealth and mHealth philosophy, health technology assessment, genetics research implications, population-mental health, gender and disparity issues, global and migration-related themes. In support of this approach, JPHR strongly encourages the use of real multidisciplinary approaches and analyses in the manuscripts submitted to the journal. In addition to Original research, Systematic Review, Meta-analysis, Meta-synthesis and Perspectives and Debate articles, JPHR publishes newsworthy Brief Reports, Letters and Study Protocols related to public health and public health management activities.
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