Objective To evaluate the analytical performance of serumamyloid A protein and C-reactive protein detection reagents based onmicrofluidic technology, so as to determine whether they can meetclinical requirements. Methods The precision, accuracy, linear range,interference test and other technical indicators of the detectionreagent were determined according to the CLSI EP scheme. Results Theintra-batch coefficients of variation of high and low concentrationsamples were 0.54% and 1.79%, and the inter-batch coefficients ofvariation were 0% and 1.20%, respectively, for the serum amyloid Adetection reagent; the intra-batch coefficients of variation of high andlow concentration samples were 0.30% and 2.28%, and the inter-batchcoefficients of variation were 0.17% and 0%, respectively, for theC-reactive protein detection reagent; the experimental results of themethodological comparison of the two methods were $\mathrm{Y}=$ -0.0609+0.9871X, ${\mathrm{R}}^{2}= {0.9975}$ and $\mathrm{Y}= {0.3354}+{0.9857}\mathrm{X},{\mathrm{R}}^{2}= {0.9990}$ , respectively,and the allowable errors were greater than the upper limit of theexpected bias confidence interval, and the biases were acceptable; thelinear range of the serum amyloid A detection reagent was $3 \sim {100.0}\mathrm{{mg}}/\mathrm{L}$ ,and the linear range of the C-reactive protein detection reagent was $3\sim {150.0}\mathrm{{mg}}/\mathrm{L}$ . 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 protein  /  C-reactive protein  /  microfluidic technology  /  analyze performance evaluation