2024 年 8 巻 2 号 p. 46-53
Mass spectrometry (MS) has increasingly been used in a wide range of biomedical fields in Japan. Among these applications, the most successful in laboratory medicine is the rapid identification of microorganisms by MALDI-TOF MS, leading to a revolutionary shift in clinical diagnostic microbiology.
In sharp contrast, the adoption of LC/MS-based assays for routine use in clinical chemistry laboratories in Japan has been very slow and limited. Although LC/MS/MS offers several advantages over immunoassays, including higher specificity, multiplexing capability, and independence from antibodies, the adoption of this technology in the real world of laboratory medicine has been hindered.
The major reasons for the limited use of LC/MS/MS in routine laboratory practice in clinical chemistry, despite its great advantages, are: 1) Laboratory tests for outpatients in Japan are expected to be performed as same-day tests, which require a rapid turnaround time within 60 minutes and high throughput, posing a challenge to current LC/MS/MS assay systems. 2) MS-based measurements conducted by laboratory-developed LC/MS/MS assays are not covered by health insurance for the majority of test items for which in-vitro diagnostics are available.
To accelerate the wide adoption of LC/MS/MS in clinical chemistry laboratories, achieving full automation of the LC/MS/MS system (preferably with a push-button design) with bidirectional access to the Hospital Information System is desperately needed. Additionally, resolving the issues related to the reimbursement of laboratory-developed LC/MS/MS testing is mandatory. Furthermore, standardization and harmonization of LC/MS/MS-based methods is another crucial step toward wider acceptance of LC/MS/MS.
