Objective:To standardize the bacterial endotoxin testing criteria for zoledronic acid injection and estab-lish a detection method using recombinant factor C(rFC).Methods:The gel-clot method(BET)was utilized to test 13 batches of zoledronic acid injection from national supervision and random inspection.Interference tests were conducted on zoledronic acid injections from three manufacturers at different concentrations(500,100,50,25 μg·mL-1)using rFC test kits from two manufacturers.Results:Detection was performed for the specification of 100 mL∶5 mg and other specifications according to＜0.50 EU per 1 mL and＜5.0 EU per 1 mg,respectively,and all results met the criteria.The recovery rate for 25 μg·mL-1 using rFC kits from both manufacturers ranged between 50％and 200％.Validation of rFC.Methods:Eight batches of zoledronic acid injection were validated at 25 μg·mL-1,five batches of zoledronic acid injection(100 mL∶5 mg)were validated at 0.5 EU·mL-1,and all recovery rates were between 50％and 200％.Conclusion:The bacterial endotoxin testing method for zoledronic acid injection can be established as follows:for large volume injection products with 100 mL or more,each 1 mL should contain less than 0.50 EU of endotoxin(following the Chinese Pharmacopoeia 2020,general chapter 1143).For other specifications,each 1 mg of zoledronic acid should contain less than 10.0 EU of endotoxin.The rFC test kit method for bacterial endotoxins involved diluting the sample with water for bacterial endotoxin testing to contain 25 μg of zoledronic acid per 1 mL,or performing 1∶1 dilution for large volume injections(100 mL∶5.0 mg specifi-cation),with recovery rate between 50％and 200％as per the kit instructions.

【Objective】 To investigate the unqualified rate of anti-HIV detection of blood screening laboratories in Beijing-Tianjin-Hebei region, and explore the differences in anti-HIV detection ability and influencing factors in each laboratory. 【Methods】 Through filling questionnaires via e-mail, the anti-HIV ELISA unqualified rate and confirmed (WB) positive results (data) from January to December 2018 from 15 blood screening laboratories in Beijing-Tianjin-Hebei region were collected. Our laboratory was responsible for data collection and confirmation, and statistics software SPSS22.0 was used for analysis. 【Results】 1) There was a statistically significant difference among the unqualified rate of anti-HIV ELISA(6.77‱~35.71‱) and confirmed positive rate(0.60‱~3.56‱) in 15 blood screening laboratories in Beijing-Tianjin-Hebei region (P<0.05); 2) There were significant differencse among the ELISA unqualified rate and the confirmed positive rate of 8 reagents for anti-HIV detection(P<0.01), and the sensitivity of the 4th generation detection reagent and the imported reagent was higher than that of the 3rd generation reagent and the domestic reagent. The anti-HIV ELISA unqualified rate of R5 was the highest (19.08‱). 3)There were significant differences in the anti-HIV ELISA unqualified rate of R1, R2, R3, R5 and R7 reagents among different blood station laboratories(P<0.05), and there were no significant differences in the anti-HIV ELISA unqualified rate of R4, R6 and R8 reagents among different blood station laboratories(P>0.05). 4)The unqualified rate of anti-HIV ELISA of laboratories using different regents showed significant differences(P<0.05), except H, J, M. The unqualified rate of imported reagent was significantly higher than that of domestic reagents of laboratories using imported and domestic reagents combinations(P<0.05), except O. 62.5% (5/8) laboratories using domestic 3^rd and 4^th generation reagent combination showed significant differences in the unqualified rates among different reagents(P<0.05); 5) The positive rate of single-reagent(62.02%~95.45%)in 15 blood screening laboratories showed significant difference(P<0.001), and A was the lowest (62.02%). 【Conclusion】 The anti-HIV detection ability among 15 blood screening laboratories in Beijing-Tianjin-Hebei region is quite different. The application of different reagents is the main factor for the difference, and other factors such as personnel, instruments and test strategies also has a great impact on the detection of anti-HIV. It is still necessary to promote the process of homogenization of blood testing quality among blood screening laboratories in Beijing-Tianjin-Hebei region.