RESUMO
Objective A kind of quantitative C reactive protein (CRP) test kit was developed with colloidal gold lateral flow method. Method The kit was prepared with double antibody sandwich technology, and by material optimization and strict process control to improve performance. Quantitative assay was realized by a specialized lateral flow reader. The kit performance was evaluated with series of tests and clinical trial. Results The kit was developed with functional sensitivity≤1 mg/L, linear range 1-200 mg/L, CV<15%and with stability of 12 months. 220 samples clinical trial showed 98.6%of coincidence rate. Pearson Correlation coefficient r is 0.987, which showed no significant difference in performance compare with control kit. Conclusion A quantitative CRP test kit was developed with easy to operating and good stability, Which can be used for point of care testing or laboratory testing.