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GTR Home > Tests > HGEM, S

Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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Recovery was used to assess accuracy; mean recovery was 112%. Intra assay precision was performed at 2 levels: CV results ranged from 2.1%-23.9% (N=20 each). Inter assay precision was performed at 2 levels: CVs (N=20 each) ranged from 3.5%-95.1% where higher CVs were obtained for physiologically low analyte concentrations. The analytical measurement range is analyte dependent and ranges from 0.04 - 15┬ÁM.

Citations

Not provided

Assay Limitation(s)

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No significant cautionary statements

Internal Test Validation Method

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This test was laboratory developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements.

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Yes
Method used for proficiency testingHelp
Intra-Laboratory
PT Description
Intra-laboratory alternative assessment of performance through quality control or patient blind testing

FDA Regulatory Clearances of the Test

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FDA Category Designation
FDA exercises enforcement discretion

Practice guidelines

  • ACMG ACT, 2022
    American College of Medical Genetics and Genomics, Newborn Screening ACT Sheet, Elevated C4 and C5 +/- Other Acylcarnitines, Glutaric Acidemia II (GA-II) (MADD), 2022
  • ACMG Algorithm,
    American College of Medical Genetics and Genomics, Algorithm, Glutaric Acidemia II (GA-II)/ MADD, Riboflavin Metabolism Disorder, Ethylmalonic Encephalopathy: C4 and C5 elevated +/- other elevated acylcarnitines (AC), 2022
  • ACMG ACT, 2021
    American College of Medical Genetics and Genomics, Newborn Screening ACT Sheet, Elevated C8 with Lesser Elevations of C6 and C10 Acylcarnitine, Medium-Chain Acyl-CoA Dehydrogenase (MCAD) Deficiency, 2021
  • ACMG Algorithm, 2021
    American College of Medical Genetics and Genomics, Algorithm, C8 Elevated + Lesser Elevations of C6 and C10, 2021

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