The pathway through LC-MS method development: in-house or ready-to-use kit-based methods?

• Published in: Clinical chemistry and laboratory medicine Vol. 58; no. 6; pp. 1002 - 1009
• Main Authors: Le Goff, Caroline, Farre-Segura, Jordi, Stojkovic, Violeta, Dufour, Patrice, Peeters, Stéphanie, Courtois, Justine, Nizet, Adrien, De Vos, Nathalie, Cavalier, Etienne
• Format: Journal Article Web Resource
• Language: English
• Published: Germany De Gruyter 25.06.2020; Walter De Gruyter & Company; Walter de Gruyter
• Subjects: Accuracy; Analytical chemistry; Calibration; Chromatography; Cortisol; Cross-reactivity; Expected values; Hormones; Human health sciences; Immunoassays; in house method; kit ready to use; Laboratories; Laboratory medicine & medical technology; LC-MS/MS; Liquid chromatography; Mass spectrometry; Mass spectroscopy; Medical equipment; Methods; Médecine de laboratoire & technologie médicale; Patient safety; Performance evaluation; Quality control; Ready to use method; Reproducibility; Sciences de la santé humaine; Scientific imaging; Steroid hormones; Steroids; kit ready to use; mass spectrometry; in-house method
• ISSN: 1434-6621; 1437-4331; 1437-4331
• DOI: 10.1515/cclm-2019-0916

Historically, the determination of low concentration analytes was initially made possible by the development of rapid and easy-to-perform immunoassays (IAs). Unfortunately, typical problems inherent to IA technologies rapidly appeared (e.g. elevated cost, cross-reactivity, lot-to-lot variability, etc.). In turn, liquid chromatography tandem mass spectrometry (LC-MS/MS) methods are sensitive and specific enough for such analyses. Therefore, they would seem to be the most promising candidates to replace IAs. There are two main choices when implementing a new LC-MS/MS method in a clinical laboratory: (1) Developing an in-house method or (2) purchasing ready-to-use kits. In this paper, we discuss some of the respective advantages, disadvantages and mandatory requirements of each choice. Additionally, we also share our experiences when developing an in-house method for cortisol determination and the implementation of an “ready-to-use” (RTU) kit for steroids analysis.