Proficiency testing for determination of photometric method of bacterial endotoxin / 中国药理学通报

ABSTRACT

Aim To design and implement the bacteri¬al endotoxin test proficiency testing plan to evaluate the laboratory's ability and level to determine bacterial en¬dotoxin. Methods According to the Chinese Pharma-copoeia (2015 edition, Vol IV) -1143 Bacterial Endo¬toxin Test-Photometric Method ( Method 2 ) , each la¬boratory used any of these methods to determine the endotoxin content of the sample to be tested. The stati- stical software JMP13 was used for statistical analysis of the feedback results of the participating laboratories. The consensus value of the participants, namely the ro¬bust average value of the effective test results of all the participating laboratories, was used as the assigned value X of the endotoxin content of the samples to be tested in the proficiency testing of the round. The re¬sults of participating laboratories were evaluated ac¬cording to the following criteria (1) the laboratory test results were within 50% to 200% of the assigned value of the sample, which was evaluated satisfactory; ( 2 ) the laboratory test results were not within the 50 -200% range of the assigned value of the sample, which was evaluated dissatisfactory. Results A total of laboratories participated in this capacity verification plan, with 45 in the laboratory with satisfactory re¬sults, with a satisfaction of 91. 8% ; There were 4 la¬boratories that received "dissatisfaction" results, all of which were not within the range of 50% -200% of the assigned value of samples, and the dissatisfaction of 8. 2% . Conclusions Most of the participating labora¬tories can accurately detect the bacterial endotoxin con¬tent in the sample to be tested, indicating that the level of bacterial endotoxin detection in our country is gener¬ally good at present.