Evaluation of the performance of serum amyloid A analyze performance evaluation and C-reactive protein detection reagents based on microfluidic technology
Objective To evaluate the analytical performance of serum amyloid A protein and C-reactive protein detection reagents based on microfluidic technology,so as to determine whether they can meet clinical requirements.Methods The precision,accuracy,linear range,interference test and other technical indicators of the detection reagent were determined according to the CLSI EP scheme.Results The intra-batch coefficients of variation of high and low concentration samples were 0.54% and 1.79%,and the inter-batch coefficients of variation were 0% and 1.20%,respectively,for the serum amyloid A detection reagent;the intra-batch coefficients of variation of high and low concentration samples were 0.30% and 2.28%,and the inter-batch coefficients of variation were 0.17% and 0%,respectively,for the C-reactive protein detection reagent;the experimental results of the methodological comparison of the two methods were Y=-0.0609+0.9871X,R2=0.9975 and Y=0.3354+0.9857X,R2=0.9990,respectively,and the allowable errors were greater than the upper limit of the expected bias confidence interval,and the biases were acceptable;the linear range of the serum amyloid A detection reagent was 3～100.0 mg/L,and the linear range of the C-reactive protein detection reagent was 3～150.0 mg/L.Conclusion The analytical performance of serum amyloid A and C-reactive protein detection reagents based on microfluidic technology can meet the needs of clinical laboratories.
serum amyloid A proteinC-reactive proteinmicrofluidic technologyanalyze performance evaluation
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