Quantitative, non-subjective results

Increased sensitivity and broader detection range compared to rapid tests

RANGES

Working range: 4%–15%

PRECISION

Intra-lot Precision

Intra-lot precision was determined by testing of HbA1c reference materials using 10 test devices from the same lot. CV ≤ 15%

Inter-lot Precision

Inter-lot precision was determined by testing of HbA1c reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

ACCURACY

HbA1c control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY

A serial concentration of HbA1c reference materials at 4%–15% was tested, and the correlation coefficient (R) is ≥0.9900.