Comparison of newborn screening protocols for congenital adrenal hyperplasia in preterm infants

J Pediatr. 2014 May;164(5):1136-40. doi: 10.1016/j.jpeds.2014.01.038. Epub 2014 Feb 28.

Abstract

Objective: To compare 2 screening protocols performed concurrently in Minnesota: (1) liquid chromatography tandem mass spectrometry steroid profiling as a second-tier test on positive fluoroimmunoassay (FIA) results; and (2) low-birthweight 3-screen protocol (FIA tests at <48 hours, 2 weeks, 4 weeks) on all infants <1800 g, regardless of result.

Study design: Population-based study of all <1800 g infants (n = 8739) born in Minnesota from 2004-2010 comparing newborn screening performance metrics of 2-tier (FIA + liquid chromatography tandem mass spectrometry) protocol (2004-2010) vs 1-tier (FIA) low-birthweight 3-screen protocol (2006-2010). False positive (FP) rates were calculated per infant's final confirmatory result. Protocol results used in different time periods (2004-2005 vs 2006-2010) were compared by 2-sample tests of proportions; results of both protocols for 2006-2010 were compared by McNemar test.

Results: First-tier testing of final dried blood spot result (n = 6625) of the low-birthweight 3-screen protocol during 2006-2010 reduced the FP rate more than 5-fold (P < .0001) compared with 2-tier testing of a single dried blood spot (n = 2114) from 2004-2005. In comparing results (n = 6625) of both protocols from 2006-2010, first-tier testing of final dried blood spot accounted for 23% of FPs; second-tier testing of the first dried blood spot accounted for 77%, yielding significantly more FP results (McNemar test, P < .0001).

Conclusion: Timing of dried blood spot collection rather than assay used played a more important role in reducing FP results of congenital adrenal hyperplasia newborn screening in low birthweight infants.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adrenal Hyperplasia, Congenital / blood
  • Adrenal Hyperplasia, Congenital / diagnosis*
  • Biomarkers / blood
  • Chromatography, Liquid
  • Clinical Protocols
  • Dried Blood Spot Testing / methods*
  • False Positive Reactions
  • Fluoroimmunoassay
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Infant, Premature, Diseases / blood
  • Infant, Premature, Diseases / diagnosis*
  • Neonatal Screening / methods*
  • Predictive Value of Tests
  • Steroids / blood
  • Tandem Mass Spectrometry / methods

Substances

  • Biomarkers
  • Steroids