Evaluation of an Ion-Exchange HPLC Device for HbA1c Measurement

Ghaith Altawallbeh, Vicky F. Makky, Amy K Saenger, Jennifer M. Peters, Anthony A. Killeen

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: The ADAMS™ HA-8180V is the 8th generation of a fully automated ion-exchange HPLC system from ARKRAY, and the first to be released onto the US market. We evaluated the HA-8180V, for routine hemoglobin A1c measurement in comparison with the Roche Cobas c501, the Tosoh G8 analyzer for normal hemoglobin, and with the Trinity analyzer for hemoglobin variants. METHODS: The analytical performance (linearity, precision, carryover, and sample stability) was assessed based on the Clinical and Laboratory Standards Institute (CLSI) and manufacturer guidelines. A comparison of the HA-8180V against two major analytical methods was performed for 100 whole blood samples. HA-8180V variant mode was also compared against the Trinity ultra2 A1c analyzer for 50 samples containing hemoglobin variants (HbC 14, HbS 14, HbD 12, and HbE 10). RESULTS: The within-run and total CVs were <0.01 and 0.75% at low HbA1c concentration and 0.46 and 0.63% at high HbA1c concentration, respectively. Linearity was shown in the concentration range 3.4-18.1% HbA1c, carryover was 0.00%, and stability values were excellent. Method comparison demonstrated a high concordance between methods. CONCLUSION: The eighth generation ADAMS HA-8180V A1c analyzer demonstrated high analytical performance adequate for routine clinical use.

Original languageEnglish (US)
Pages (from-to)695-703
Number of pages9
JournalThe journal of applied laboratory medicine
Volume5
Issue number4
DOIs
StatePublished - Jul 1 2020

Bibliographical note

Publisher Copyright:
© American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please contact journals.permissions@oup.com.

Keywords

  • diabetes
  • evaluation
  • HA-8180V
  • Hb variants
  • HbA1c

PubMed: MeSH publication types

  • Comparative Study
  • Journal Article
  • Research Support, Non-U.S. Gov't

Fingerprint

Dive into the research topics of 'Evaluation of an Ion-Exchange HPLC Device for HbA1c Measurement'. Together they form a unique fingerprint.

Cite this