Evaluation of the In2it analyzer for HbA1c determination

Area of Science:

• Clinical Chemistry
• Analytical Biochemistry
• Diabetes Mellitus Diagnostics

Background:

• Hemoglobin A1c (HbA1c) is crucial for monitoring glycemic control in diabetes.
• Accurate and reliable HbA1c assays are essential for effective patient management.
• New analytical devices are needed to meet the demands of clinical settings.

Purpose of the Study:

• To evaluate the analytical performance and practicability of the new In2it analyzer for HbA1c determination.
• To assess the In2it analyzer's suitability for both laboratory and point-of-care testing.
• To compare the In2it analyzer with established HPLC and immunoassay methods.

Main Methods:

• Analytical performance testing of the In2it analyzer, including precision, interference, and linearity.
• Correlation studies with a high-performance liquid chromatography (HPLC)-based Variant II analyzer and an immunoassay-based DCA 2000 analyzer.
• Evaluation of the analyzer's practicability and compliance with good laboratory practices.

Main Results:

• The In2it analyzer demonstrated good linearity (4-14% HbA1c) and precision (CVs 2.4-3.9%).
• Satisfactory correlation was observed with HPLC Variant II (r²=0.974) and DCA 2000 (r²=0.794), though some random differences occurred with DCA 2000.
• The method showed no significant interference from common hemoglobin variants, labile HbA1c, or common clinical conditions like hyperbilirubinaemia and hypertriglyceridaemia.

Conclusions:

• The In2it analyzer is suitable for HbA1c testing in small laboratory batches and point-of-care settings.
• Overall analytical performance is satisfactory, but software requires upgrades for quality control, traceability, and data security.
• Caution is advised regarding potential underestimation of HbA1c results in cases of high hypertriglyceridaemia.