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Aim To evaluate the equivalence between micro kinetic chromogenic assay anrl kinetic chromogenic assay in order to provide data support for the use of alternative methods.Methods Detection conditions; micro kinetic chromogenic assay and kinetic chromogenic assay limulus reagent were used, sample amount of each well and limulus reagent was 25 jxL ( kinetic chromogenic assay was 100 jxL) , detection wavelength was 405 nm, ONSET OD value was 0.03, and half- well elisa plate was used for detection ( kinetic chromogenic assay was ordinary ELISA plate).The equivalence of the two methods was evaluated by various statistical methods, such as equivalence test, in collaboration with four laboratories in China.Results The results of one-way an OVA, paired T test and equivalence test were consistent, indicating that there were some differences between the existing kinetic chromogenic assay of different manufacturers, while there was no significant difference between the trace or conventional amount of reagent used by each manufacturer.Conclusions Micro kinetic chromogenic assay is e- quivalent to existing reagents in terms of accuracy and recoverv.J.
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Objective To develop a quantitative,highly sensitive,low detection limit and fast endotoxin(ET) biosensing detection system by utilizing the piezoelectric crystal's damping effect(non-mass effect) in the liquid phase environment.Methods The sensor probe of better performance (eliminating the quality load effects and improving the liquid solid coupling effect) was obtained by using the smoothing processing and hydrophilic processing of a quartz crystal sensor probe surface,thus the stability and repeatability of measurement were increased and the low detection limit of measurement was decreased.The whole measurement system was made into a miniature and automated endotoxin detection system by using CPLD device and LabView software to realize the automatic collection,and analysis and results display of measurement data.Results The good linear relationship existed between different concentrations of endotoxin and the stable value of frequency shift.Conclusion By the established data of frequency shift,the endotoxin concentration can be obtained accurately and conveniently.