Validation of lamellar body counts using three hematology analyzers

Christina M. Lockwood, J. Chance Crompton, Joan K. Riley, Keith Landeros, Dennis J. Dietzen, David G. Grenache, Ann M. Gronowski

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

The lamellar body count (LBC) represents an alternative method to the TDx-FLM II (Abbott Laboratories, Abbott Park, IL), which is planned to be discontinued, for assessing fetal lung maturity. Our objective was to validate the LBC on 3 hematology analyzers (Coulter LH 750 and Coulter Ac•T diff2, Beckman Coulter, Brea, CA; and Sysmex XE-2100, Sysmex, Mundelein, IL) to serve as a template for other laboratories attempting to perform in-house validation. Intra-assay and interassay coefficients of variation ranged from 1.7% to 21.8% and 1.9% to 7.1%, respectively, and all analyzers demonstrated excellent linearity. Whole blood and meconium were shown to interfere with LBCs, and specimens with these contaminants should be tested using phosphatidyl glycerol. With a TDx-FLM II cutoff of 55 mg/g or more and an LBC cutoff of 50,000/μL or more for maturity, concordance between the TDx-FLM II and the LBC on all instruments was poor (<80% in all cases). Concordance between hematology analyzers was excellent (≥94%). When laboratories are performing in-house validations, they should not correlate LBC with TDx-FLM II results without outcome data. Correlation with another validated LBC method is preferred.

Original languageEnglish
Pages (from-to)420-428
Number of pages9
JournalAmerican journal of clinical pathology
Volume134
Issue number3
DOIs
StatePublished - Sep 1 2010

Keywords

  • Fetal lung maturity
  • Fluorescent polarization
  • Lamellar body count

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