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Table. 1.

Table. 1.

Post-implementation monitoring parameters for LC-MS methodologies [5]

Monitoring Parameter CLSI-C62A Recommendation
System suitability test • Analysis of system suitability sample at least three times* before each analytical run
• Establishment of acceptable criteria for retention time, peak height, peak width, ion ratio, and signal-to-noise ratio
Double blank • Analyte peak area in double blank <20% in peak area for the sample at the LLMI
• IS peak area in double blank <5% of peak area for the sample
Blank • Analyte peak area in blank <20% of peak area for the sample at the LLMI
Calibrator accuracy • Bias ≤15% for all calibrators above the LLMI, ≤20% for LLMI
• r2 of calibration curve >0.995
IS peak area • Establishment of acceptable criteria for IS peak area range
• Comparable IS peak area across calibrators and controls in the same run (CV of 5-10%*)
• Consistent IS peak area of calibrators between runs
Retention time (Rt) and/or Relative retention time (RRt) • Rt or RRt in sample within 2.5% of the mean Rt/RRt of the calibrators in the same batch (and between batches)
Ion ratio • Establishment of acceptable criteria for ion ratio
• Comparable ion ratio across calibrators in the same run
• Comparable mean ion ratio of calibrators between run
• Ion ratio in the patient samples within 20%* of the mean ion ratio of the calibrators, if the signal of the qualifier ion is >50% that of the quantifier ion

*These figures are not compulsory, but are recommended.

Abbreviations: IS, internal standard; LLMI, lower limit of measuring interval.

Lab Med Online 2020;10:185~196 https://doi.org/10.3343/lmo.2020.10.3.185
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