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Abstract Objective: To assess an automatic detection kit for quantitative determination of total galactose on dried blood spots of newborns, which was developed by Guangzhou Fenghua Bioengineering Co., Ltd. Methods The performance of this kit was evaluated by quantitative determination of total galactose based on fluorescence assay. Results The effective linearity range of the kit was 2.5~70 mg/dL, and the analytical sensitivity was not higher than 0.1 mg/dL. The intra-assay and inter-assay coefficients of variation were no more than 10% and 15%, respectively. Coefficients of variation about calibrator were under 20%. When the kit was stored at 37 °C for 7 days, the change of fluorescence values were not higher than 15%. These results demonstrate the kit has a good stability. Moreover, it has a good correlation with those kits developed by foreign brand, with no significant difference (P>0.05）. Conclusion As a simple and efficient automated kit, it is suitable for mass newborn screening application.
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