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Table 1 Evaluation list to set up LC-MS/MS in a clinical laboratory

From: Lessons learned: establishing a CLIA-equivalent laboratory for targeted mass spectrometry assays – navigating the transition from research to clinical practice

Main Space

 Mass Spec, HPLC, Computer, Liquid N2, Noise, and venting

Related Infrastructures

 Bench: fixed |removable (recommended for easy access to the back for PM or services)

 Electrical system: dedicated electricity supply | UPS (NO UPS for GS-MS!)

 Venting System: organic solution used from MS

 Liquid nitrogen: N2 tanks (mostly recommended by manufactures) | generators (dual or triple generator)

 Noise: a separate space | Insulation

 Temperature: constant

Staff

 A good med tech can be trained to run MS, especially when no method development involved

 MS requires constant attention and more technically challenge than the current clinical lab assays

 Data needs to be reviewed individually

 May not be good to everyone

 Can be treated as a career ladder

Timelines

 Planning, evaluation, purchase, installation, training, testing; – 9 months to 1 year

Training

 On-site preferred (one to two weeks)

 Create the methods for your specific needs

Methods to use

 Choose the method you will use for your assay

 For organic extraction, fume hood or ventilation is required

For automated, cost of the automation will be considered

Visit on site

 Find somebody you know/trust who is currently using the MS you are interested and get feedback from them

 Send samples to companies to test the MS system (demo chemists)

Interface between MS data to current clinical database

 No interface available from companies currently

 May need to hire a programmer to write an interface to transfer data (cost) to avoid human error from manual data transfer

Cost of the instrument

 Instrument can be expensive

 Typically capital expenditure is required.

 Return on investment is determined by multiple factors

Cost of service contract

 Suggest pre-buy if possible to get the current price and also with discounts