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(1) Background: At present, the only potency assay approved in China for the in-country testing of botulinum toxin type A for injection products is the mouse bioassay (MBA). The Chinese market for neurotoxin products is rapidly expanding, but MBAs are subject to high variability due to individual variations in mice, as well as variations in injection sites, in addition to the limited number of batches tested for one MBA. Compared with the mLD50 method, the cell-based potency assay (CBPA) developed for the potency testing of onabotulinumtoxinA (BOTOX) by AbbVie not only does not use any experimental animals but also allows for significant time and cost savings. Due to the significant benefits conferred by the replacement of the mLD50 assay with CBPA in China, the CBPA method has been transferred, validated, and cross-validated to demonstrate the equivalence of the two potency methods. (2) Methods: The differentiated SiMa cells were treated with both BOTOX samples and the reference standard, and the cleaved SNAP25197 in the cell lysates was quantified using Chemi-ECL ELISA. A 4-PL model was used for the data fit and sample relative potency calculation. The method accuracy, linearity, repeatability, and intermediate precision were determined within the range of 50% to 200% of the labeled claim. A statistical equivalence of the two potency methods (CBPA and mLD50) was initially demonstrated by comparing the AbbVie CBPA data with NIFDC mLD50 data on a total of 167 commercial BOTOX lots (85 50U lots and 82 100U lots). In addition, six lots of onabotulinumtoxinA (three 50U and three 100U) were re-tested as cross-validation by these two methods for equivalence. (3) Results: The overall assay's accuracy and intermediate precision were determined as 104% and 9.2%, and the slope, R-square, and Y-intercept for linearity were determined as 1.071, 0.998, and 0.036, respectively. The repeatability was determined as 6.9%. The range with the acceptable criteria of accuracy, linearity, and precision was demonstrated as 50% to 200% of the labeled claim. The 95% equivalence statistic test using margins [80%, 125%] indicates that CBPA and mLD50 methods are equivalent for both BOTOX strengths (i.e., 50U and 100U). The relative potency data from cross-validation were within the range of ≥80% to ≤120%. (4) Conclusions: The CBPA meets all acceptance criteria and is equivalent to mLD50. The replacement of mLD50 with CBPA is well justified in terms of ensuring safety and efficacy, as well as for animal benefits. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to detect the epidemiological relevance between adenoid hypertrophy (AH) and rhinosinusitis, and AH and allergic rhinitis (AR) through an Internet search. Methods: Internet search query data from January 2011 to December 2019 in China were retrieved from the Baidu Index (BI). Spearman's correlation coefficients were used to detect the correlation among the search volumes of AH, rhinosinusitis, and AR. We also collected search data from the first 5 months of 2020, when quarantine was implemented in China due to the coronavirus disease 2019 epidemic. Then, we compared the search data to those obtained during the same period in 2019 to assess the effects of isolation on AH and AR. Results: Statistically significant relevance was found between the search variations of AH and rhinosinusitis during 2011–2019 (R = 0.643, P < 0.05). However, the relationship between AH and AR was weak (R = − 0.239, P < 0.05) and that between rhinosinusitis and AR (R = − 0.022, P > 0.05) was not relevant. The average monthly search volume of AH and rhinosinusitis had a strong correlation (R = 0.846, P < 0.01), but AH and AR and rhinosinusitis and AR were not correlated (R = – 0.350, P > 0.05; R = – 0.042, P > 0.05, respectively). AH and rhinosinusitis search volumes decreased consistently during the first 5 months of 2020 (isolation), whereas that for AR increased during January–February. Conclusion: AH had an epidemiological relationship with rhinosinusitis, which was not consistent with AR. The decrease in public gathering effectively reduced the morbidities of AH and rhinosinusitis but not those of AR. [ABSTRACT FROM AUTHOR]

Co-infection with hepatitis delta virus (HDV) and hepatitis B virus (HBV) has been shown to be associated with a more severe form of acute and chronic hepatitis. Cloning and expression of recombinant HDV antigen (rHDAg) in Escherichiacoli are described. Using purified rHDAg, a cost-effective indirect anti-HDV enzyme-linked immunosorbent assay (ELISA) kit was developed. Direct comparison of 15 known HDV-positive sera and 15 HDV-negative sera showed concordance agreement between the new assay kit and the Abbott Murex Anti-Delta (total) kit. In addition, 1,486 hepatitis B surface antigen (HBsAg) positive blood samples collected from various areas of China were tested using this indirect anti-HDV ELISA. It was found that 1.2% (95% CI: 0.7-1.9%) of the samples were anti-HDAg positive. It is suggested that the prevalence of HDV and HBV co-infection in China is relatively low., (Copyright © 2012 Wiley Periodicals, Inc.)