In-House vs. Kit-Based LC-MS/MS Methods: A Practical Guide for Clinical Laboratories
Clinical laboratories adopting LC-MS/MS face a fundamental choice between developing in-house methods and purchasing ready-to-use kits. This review weighs the advantages of each approach, covering validation requirements, regulatory considerations, cost, and flexibility. Using cortisol and steroid panel implementations as case studies, the authors illustrate the trade-offs between the customisability of in-house development and the faster deployment of commercial kits.
The original study
The pathway through LC-MS method development: in-house or ready-to-use kit-based methods?
- Authors
- Le Goff C, Farre-Segura J, Stojkovic V, Dufour P, Peeters S, Courtois J, et al.
- Journal
- Clinical chemistry and laboratory medicine
- Type
- Journal Article, Review
- PMID
- 32069223
Original abstract
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.