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Harmonizing Newborn Screening Laboratory Proficiency Test Results Using the CDC NSQAP Reference Materials.

Charles Austin Pickens1, Maya Sternberg1, Mary Seeterlin2

  • 1Centers for Disease Control and Prevention, Division of Laboratory Sciences, Newborn Screening and Molecular Biology Branch, MS F19, Atlanta, GA 30341, USA; ogh6@cdc.gov (C.A.P.); mrs7@cdc.gov (M.S.); jvm0@cdc.gov (J.M.); ijz6@cdc.gov (C.C.).

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Summary

Harmonizing newborn screening (NBS) results using common quality control (QC) materials can improve data comparability between laboratories. This study assessed harmonization of proficiency test (PT) data, showing reduced variation in NBS testing.

Keywords:
mass spectrometrymetabolitenewborn screeningnormalizationproficiency testing

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Area of Science:

  • Clinical Chemistry
  • Biochemistry
  • Public Health

Background:

  • Newborn screening (NBS) laboratories face challenges comparing mass spectrometry results due to diverse methodologies.
  • Lack of standardization hinders accurate comparison of results and cutoff values.

Purpose of the Study:

  • To evaluate the harmonization of laboratory proficiency test (PT) results in NBS using quality control (QC) data.
  • To assess the feasibility of using common QC materials for inter-laboratory data comparison.

Main Methods:

  • Utilized QC and PT data from 302 NBS laboratories in 2019.
  • Employed dried blood spot cards with varying metabolite concentrations for QC.
  • Regressed laboratory QC data against CDC QC data to derive harmonization parameters.

Main Results:

  • Harmonization generally reduced overall variation in PT data across laboratories.
  • Analysis highlighted inter- and intra-method variability for metabolites like glutarylcarnitine (C5DC), tyrosine, and phenylalanine.
  • Identified limitations in using retrospective data for harmonization.

Conclusions:

  • Harmonizing NBS data with common QC materials shows promise for improving inter-laboratory result comparison.
  • Further studies are needed to address limitations and confirm the feasibility of this harmonization approach.