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 language | English (US) |
|---|---|
| Pages (from-to) | 695-703 |
| Number of pages | 9 |
| Journal | The journal of applied laboratory medicine |
| Volume | 5 |
| Issue number | 4 |
| DOIs | |
| State | Published - Jul 1 2020 |
Bibliographical note
Publisher Copyright:© 2020 American Association for Clinical Chemistry. All rights reserved.
Keywords
- HA-8180V
- Hb variants
- HbA1c
- diabetes
- evaluation
