Study on equivalence between micro kinetic chromogenic assay and kinetic chromogenic assay
- Author:
Yu-Sheng PEI
1
;
Chen CHEN
1
;
Ying GENG
1
;
Hua GAO
1
;
Tong CM
1
Author Information
- Publication Type:Journal Article
- Keywords: alternative method; bacterial endotoxin test method; bioassay; kinetic chromogenic assay; limulus reagent; pyrogen
- From: Chinese Pharmacological Bulletin 2022;38(7):1107-1110
- CountryChina
- Language:Chinese
- Abstract: 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.
