Immunoturbidimetric assay of glycated hemoglobin

We investigated the performances of HbA1c determination by a latex enhanced turbidimetric immunoassay using the specific monoclonal antibodies (Unimate, Roche) against the β‐N‐terminal fragments. The coefficients of variation ranges from 1.7 to 3.8% within assay (n = 30) and from 3.9 to 4.9% between...

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Bibliographic Details
Published in:Journal of clinical laboratory analysis 1999, Vol.13 (1), p.5-8
Main Authors: Metus, Paolo, Ruzzante, Nicoletta, Bonvicini, Piero, Meneghetti, Martina, Zaninotto, Martina, Plebani, Mario
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal
Blood Glucose - metabolism
Diabetes Mellitus - blood
fetal hemoglobin
Fetal Hemoglobin - analysis
Glycated Hemoglobin A - analysis
glycated hemoglobin-labile fraction
glycemic balance control
HbA1c
Humans
Immunoassay
Latex
latex enhanced immunoassay
Nephelometry and Turbidimetry
Original
Quality Control
Reproducibility of Results
Sensitivity and Specificity
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Summary:We investigated the performances of HbA1c determination by a latex enhanced turbidimetric immunoassay using the specific monoclonal antibodies (Unimate, Roche) against the β‐N‐terminal fragments. The coefficients of variation ranges from 1.7 to 3.8% within assay (n = 30) and from 3.9 to 4.9% between assay (n = 20). The assay was linear from 2.5 to 14.9% of HbA1c. No interferences was found from fetal, carbamylated, or variant (S) hemoglobins and from labile Schiff adduct with glucose. The following relationship was derived from fresh sample comparison between HPLC (Diamat‐BioRad) (x) and immunoassay (y) method: y = 0.971 x + 0.87%, r = 0.98, n = 115. The immunoassay provides a highly precise and specific method for HbA1c. J. Clin. Lab. Anal. 13:5–8, 1999. © 1999 Wiley‐Liss, Inc.
ISSN:0887-8013
1098-2825
DOI:10.1002/(SICI)1098-2825(1999)13:1<5::AID-JCLA2>3.0.CO;2-S