Latex-enhanced immunoturbidimetric assay of human HbA1c using a highly specific mouse anti-human monoclonal antibody...

Diabetes is an increasingly common metabolic disorder that is routinely diagnosed through clinical assessments, including fasting blood glucose and oral glucose tolerance testing. In recent years, a glycosylated form of hemoglobin (HbA1c) has emerged as a key diagnostic marker for diabetes. Various methods to detect HbA1c have been developed, each offering advantages and disadvantages.

Here, we developed an anti-human monoclonal antibody (HbA1c-6C2) with high purity and specificity, which was applied to detect HbA1c in human blood samples using on a latex-enhanced immunoturbidimetric assay (LEIBA).

The LEIBA incorporating HbA1c-6C2 demonstrated excellent analytical performance. Linearity was confirmed across the HbA1c concentration range of 3.8% to 14.0%, with coefficients of variation below 1.5% for repeated detection at high and low concentration levels. Method comparison against high-performance liquid chromatography yielded a strong positive correlation (R² = 0.99), indicating high concordance with established reference standards.

The anti-human monoclonal antibody HbA1c-6C2, applied within a LEIBA, demonstrated strong linearity, high precision, stability, and accuracy for detecting HbA1c in human blood.