Transcription
Between Method/Laboratory MSMSAnalyte HarmonizationUsing CDC Quality Control MaterialsMary A. Seeterlin1, E. Stanley1, R. Grier2,K. Cavanagh1, P. Rinaldo3, V. DeJesus41. Michigan Department of Community Health, Lansing, Michigan,2. Detroit Medical Center, Children’s Hospital of Michigan,3. Department of Laboratory Medicine and Pathology, Mayo ClinicCollege of Medicine, Rochester, Minnesota,4. Centers for Disease Control and Prevention, Atlanta, GA.
2009 Directive Validate PerkinElmer NeoBaseTM Nonderivatized MSMS Kit on Waters TQD– Previously PerkinElmer NeoGram Derivatized MSMS Kit on SCIEX 2000 Evaluate cutoffs with respect to R4target cutoff ranges
Validation Assessments Precision Linearity Accuracy NeoBaseTM Kit Controls CDC Quality Control Samples Cutoffs: NeoGram-NeoBase MethodComparison
Methionine (Met)NeoBase (μmol/L)Method Comparison Analysis11 PT Samples332 Normal Patient samplesHigh and Low Kit ControlsTrue Positive samplesNeoGram (μmol/L)
Methionine (Met)NeoBase Met Cutoff (56)NeoBase (μmol/L)NeoBase 0.775 * NeoGramNeoGram Met Cutoff (74)NeoGram (μmol/L)
Methionine (Met)NeoBase (μmol/L)Method Comparison AnalysisNeoGram (μmol/L)(umol/L)
Methionine (Met)NeoBase Met Cutoff (56)NeoBase (μmol/L)Method Comparison AnalysisNeoGram Met Cutoff (74)NeoGram (μmol/L)
NeoGram Met CutoffEquivalent NeoBase Met Cutoff
Validation GoalsEvaluate Cutoffs NeoGram/NeoBase Method Comparison All MSMS analytes cutoffs evaluated Region 4 Cutoff Range Comparison: Could this Method Comparison technique workfor Between Laboratory Cutoff Comparison?
CutoffsCutoff evaluation with respect to Region 4 target cutoff ranges Why do some of our cutoffs not coincide with the R4 target cutoff range? Differences in the Methods Extraction technique Instrumentation Internal Standard Calibration Technique Standard Calibration Material Use (Traceable to National Standards) Cutoffs in question are not clinically valid
MI NeoGram Cutoff 74Target Range MI NeoBase Cutoff 56
Target Range Better?
Equivalent!Target Range Better?
Target Range:
Succinylacetone (SA)NeoBase (μmol/L)NeoBase 0.144 * CDCCDC (μmol/L)
Succinylacetone (SA)NeoBase (μmol/L)NeoBase 0.247 * MayoMayo (μmol/L)
Mayo SUAC CutoffEquivalent NeoBase SUAC Cutoff
Mayo SUAC CutoffCutoff set to 1.0 (99.99%ile 0.82)
Succinylacetone (SA)Mayo (μmol/L)NeoBase 4.051 * MayoNeoBase (μmol/L)
Succinylacetone (SA)TP TYR1: SUACMayo 4.051 * Neobase – 0.29731Calculated Mayo 35.2 µmol/LMayo (μmol/L)Mayo 35.2 µmol/LFP TYR1MI Neobase 8.76 µmol/LNeoBase (μmol/L)
NeoGram Cutoff 0.41Target Range
Glutarylcarnitine (C5DC)NeoGram (μmol/L)NeoGram 5.168 * MayoMayo (μmol/L)
Mayo C5DC CutoffEquivalent NeoGram C5DC Cutoff
MI Equivalent Cutoff 0.765NeoBase C5DC 99.99%tile 0.732MI TP GAI: C5DC 0.46NeoGram Cutoff 0.41Target Range Mayo Cutoff 0.15
Target Range MI Cutoff 68
Arginine (Arg)NeoGram 3.550 * MayoNeoGram (μmol/L)MI 107 µmol/LTP ARGMayo 29.5 µmol/LMayo (μmol/L)
Mayo Arg CutoffEquivalent NeoGram Arg Cutoff
Target Range MI Equivalent Cutoff 85MI Cutoff 68Mayo Cutoff 25
Free carnitine (C0)NeoGram (μmol/L)NeoGram 1.781 * MayoMayo (μmol/L)
Free carnitine (C0)NeoGram (μmol/L)NeoBase 1.781 * MayoSample Exchange - 6 months.Mayo (μmol/L)
Malonylcarnitine (C3DC)MI NeoBase (μmol/L)NeoBase 0.096 * MissouriMissouri NeoGram (μmol/L)
Malonylcarnitine (C3DC)MI NeoBase (μmol/L)NeoBase 0.096 * MissouriTP MALMI 0.096 * MO 0.0485Calculated MI 0.60 µmol/LMI C3DC 0.60 µmol/LMO C3DC 5.75 µmol/LMissouri NeoGram (μmol/L)
ConclusionsHarmonization Using CDC QualityControl Materials: Allows Harmonization of Cutoffs Allows Harmonization of TP AnalyteConcentrations
Conclusions Allowed for an accurate comparison of CutoffValues between Michigan and Mayo. Identified that C16OH, C0, Cit, Cit/Arg, andMet cutoffs required correction.
Acknowledgements:MI NBS Team – Eleanor StanleyDr. Robert Grier – CHMMC, BGLPatrick V. Hopkins – MissouriMarie-Thérèse Berthier, Quebec – NeoBaseSheila Weiss/Bill Hoffman – WashingtonDr. Victor DeJesus/CDC Quality Assurance ProgramDr. Piero Rinaldo/David McHugh - Region 4 Collaborative
CDC (μmol/L)NeoBase (μmol/L)
CDC equivalent uMol/LCDC equivalent uMol/L
CDC equivalent uMol/L?
Between Method/Laboratory MSMS Analyte Harmonization Using CDC Quality Control Materials Mary A. Seeterlin 1, E. Stanley , R. Grier2, K. Cavanagh1, P. Rinaldo3, V. DeJesus4 1. Michigan Department of Community Health, Lansing, Michigan, 2. Detroit Medical Center, Children's Hospital of Michigan, 3. Department of Laboratory Medicine and .
