Evaluation of the quality and performance of self-made C-reactive protein test kit

Objective To evaluate the quality and performance of self-made C-reactive protein test kit(latex immunoturbidimetry).Methods The limitation of detection,precision,linearity,recovery,expiry term was measured.200 blood samples were used for the comparative study with imports.Results Limitation of detection:0.72 mg/L.Precision:the within-run relative standard deviations of two different concentration samples were 3.09% and 6.75%.The day to day relative standard deviations of two different concentration samples were 6.47% and 6.84%.Linearity:the linear range was from 1 mg/L to 215 mg/L.The correlation coefficient was0.99.Accuracy:the average recovery was 112.5%.The system error was less than 1/2TEa.Expiry term:18 months.Contrast experiment:the results between self-made C-reactive protein test kit and imports had no significant difference.Conclusion The test kit is a valueable diagnostic tool for C-reactive protein rapid and accurate detection.