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Adaptation of latex-enhanced assay for percent glycohemoglobin to a Dade Dimension^® analyzer

¹ Department of Clinical Biochemistry, St. Bartholomew's and the Royal London School of Medicine & Dentistry, Turner Street, London E1 2AD, UK.

² Department of Clinical Biochemistry, The London Hospitals Trust, Whitechapel, London E1 1BB, UK.
^a Author for correspondence. Fax (44) 71-377-1544; e-mail p.g.holownia{at}mds.qmw.ac.uk

At present no method for glycohemoglobin (%HbA_1c) is automated on a main-line analyzer to allow joint measurement with other indicators of diabetic control such as glucose and cholesterol. We describe an adaptation of a latex-enhanced competitive immunoassay for quantifying %HbA_1c to the Dade International Dimension^® analyzer. After a manual hemolysis step, HbA_1c and total hemoglobin (Hb) are determined separately. The concentration of glycated ß-subunit is obtained from the immunoassay, whereas Hb is assessed colorimetrically from a derivatized form. Both reactions were fully optimized for accuracy, precision, and specificity on the Dimension; stabilities of reagents and calibration were established; and potential interferences were assessed. The analyzer gave reliable results over the required clinical range of 1–15% HbA_1c. Within-run and total assay variation were within 5% of the target CV limits, as determined by ANOVA with three representative sample pools across 20 days. Close agreement with an established HPLC procedure and a commercially available enzyme immunoassay was observed for 140 samples from clinically defined patient groups. Additional samples from patients with hemoglobinopathies (n = 20) demonstrated a more complex relationship between methods. We conclude that adaptation of the method for use with the Dimension analyzer is a valid method for quantifying %HbA_1c.

Key Words: indexing terms: diabetes mellitus • hemoglobin variants

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