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

Clin Chem Lab Med. 2020 Jun 25;58(6):1002-1009. doi: 10.1515/cclm-2019-0916.

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.

Keywords: in-house method; kit ready to use; mass spectrometry.

Publication types

  • Review

MeSH terms

  • Chromatography, Liquid / methods*
  • Humans
  • Limit of Detection
  • Mass Spectrometry / methods*