Development of a 25-Hydroxyvitamin D Liquid Chromatography–Tandem Mass Spectrometry Assay, Cleared by the Food and Drug Administration, via the De Novo Pathway

Nicole V. Tolan

doi:10.1016/j.cll.2018.05.006

Development of a 25-Hydroxyvitamin D Liquid Chromatography–Tandem Mass Spectrometry Assay, Cleared by the Food and Drug Administration, via the De Novo Pathway

Nicole V. Tolan

Division of Laboratory and Genomic Medicine

Research output: Contribution to journal › Review article › peer-review

3 Scopus citations

Abstract

Despite great improvement in vitamin D assay standardization, inaccurate recoveries of 25(OH)D ₂ remain for immunoassays and many laboratory-developed LC-MS/MS methods don't separate out the 3-epimer interferents. Through the process of obtaining FDA-clearance, we learned that communication is key. Mass spectrometry-based assays raise different questions of safety and efficacy than the predicate immunoassays, with fewer risks due to increased accuracy. This process required improving our quality management system to support the development and registration of an in vitro diagnostic device. There are similar examples for a number of analytes, requiring expeditious entry of FDA-cleared LC-MS/MS methods into clinical laboratories.

Original language	English
Pages (from-to)	553-564
Number of pages	12
Journal	Clinics in Laboratory Medicine
Volume	38
Issue number	3
DOIs	https://doi.org/10.1016/j.cll.2018.05.006
State	Published - Sep 2018

Keywords

25-Hydroxyvitamin D2
3-Epi-25-hydroxyvitamin D
CDC Vitamin D Standardization Certification Program (VDSCP)
FDA de novo pathway
Traceable LC-MS/MS method

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10.1016/j.cll.2018.05.006

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title = "Development of a 25-Hydroxyvitamin D Liquid Chromatography–Tandem Mass Spectrometry Assay, Cleared by the Food and Drug Administration, via the De Novo Pathway",

abstract = " Despite great improvement in vitamin D assay standardization, inaccurate recoveries of 25(OH)D 2 remain for immunoassays and many laboratory-developed LC-MS/MS methods don't separate out the 3-epimer interferents. Through the process of obtaining FDA-clearance, we learned that communication is key. Mass spectrometry-based assays raise different questions of safety and efficacy than the predicate immunoassays, with fewer risks due to increased accuracy. This process required improving our quality management system to support the development and registration of an in vitro diagnostic device. There are similar examples for a number of analytes, requiring expeditious entry of FDA-cleared LC-MS/MS methods into clinical laboratories.",

keywords = "25-Hydroxyvitamin D2, 3-Epi-25-hydroxyvitamin D, CDC Vitamin D Standardization Certification Program (VDSCP), FDA de novo pathway, Traceable LC-MS/MS method",

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N2 - Despite great improvement in vitamin D assay standardization, inaccurate recoveries of 25(OH)D 2 remain for immunoassays and many laboratory-developed LC-MS/MS methods don't separate out the 3-epimer interferents. Through the process of obtaining FDA-clearance, we learned that communication is key. Mass spectrometry-based assays raise different questions of safety and efficacy than the predicate immunoassays, with fewer risks due to increased accuracy. This process required improving our quality management system to support the development and registration of an in vitro diagnostic device. There are similar examples for a number of analytes, requiring expeditious entry of FDA-cleared LC-MS/MS methods into clinical laboratories.

AB - Despite great improvement in vitamin D assay standardization, inaccurate recoveries of 25(OH)D 2 remain for immunoassays and many laboratory-developed LC-MS/MS methods don't separate out the 3-epimer interferents. Through the process of obtaining FDA-clearance, we learned that communication is key. Mass spectrometry-based assays raise different questions of safety and efficacy than the predicate immunoassays, with fewer risks due to increased accuracy. This process required improving our quality management system to support the development and registration of an in vitro diagnostic device. There are similar examples for a number of analytes, requiring expeditious entry of FDA-cleared LC-MS/MS methods into clinical laboratories.

KW - 25-Hydroxyvitamin D2

KW - 3-Epi-25-hydroxyvitamin D

KW - CDC Vitamin D Standardization Certification Program (VDSCP)

KW - FDA de novo pathway

KW - Traceable LC-MS/MS method

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DO - 10.1016/j.cll.2018.05.006

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C2 - 30115398

AN - SCOPUS:85051412404

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Development of a 25-Hydroxyvitamin D Liquid Chromatography–Tandem Mass Spectrometry Assay, Cleared by the Food and Drug Administration, via the De Novo Pathway

Abstract

Keywords

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