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Table. 3.

Table. 3.

Example details to be reviewed or captured during the test phase of LC-MS/MS assays

Component Required information
Batch Sample list checked against samples to be assayed Sample identity
Batch order confirmed Batch layout
Sample preparation Sample preparation materials available Method SOP
Test samples at equilibrium and homogeneous Time and mixing check
Calibrator and quality control lots confirmed Lot numbers and record
Pertinent times recorded (time-defined steps in the SOP) Start and stop time for appropriate components
Pipette(s) utilized Pipette serial number and volume
Reagent lots Lots recorded, documented confirmed purity/activity for critical components
Steps documented Preparation checklist
Abnormal results/preparative deviations Note to preparation checklist
Analysis System equilibrated Pre-run details
Pre-run injections Method SOP
Plate/vial location Preparation checklist

Abbreviations: LC-MS/MS, liquid chromatography-tandem mass spectrometry; SOP, standard operating procedure.

Ann Lab Med 2022;42:531~557

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