A new quality control method for lateral flow assay

Precision and repeatability are challenging issues in point of care testing (POCT) analysis. Herein, we proposed a lateral flow assay (LFA) based on internal quality control microspheres to realize the accurate diagnosis of HbA1c in human body. Fluorescein cy5 decorated microspheres are used as labels for HbA1c detection, and BSA- fluorescein isothiocyanate (FITC) decorated microspheres are used as internal quality control labels. One test line was employed in the strip for the detection of glycosylated hemoglobin (HbA1c). This method can eliminate the interference of environmental factors (temperature, humidity, etc.) to LFA in the process of chromatography, and improve the precision and accuracy of HbA1c detection. The CV for detection of low concentration HbA1c was 1.05%, and the CV for detection of high concentration HbA1c was 0.69%. We envision the method to have great prospect in in vitro diagnosis (IVD).