Science and technological advancements drive human progress, with laboratory animals serving as essential resources for developments in life sciences and medicine. However, the waste generated by these animals presents new challenges for urban management. Issues such as classification, recycling, effective utilization, and biohazard elimination must be addressed, necessitating the development of regulations, standards, and norms to keep pace with advancements. The construction of quality management system is the foundation and framework for the management of inspection and testing organizations. It should have strong operability and inspectability, enabling continuous improvement of the management level and enhancing the stability of basic management. However, current quality management systems often lack clarity in managing laboratory animal waste, including undefined disposal processes for non-medical institutions, inaccurate waste classification, and inadequate disposal methods for different waste categories. This paper addresses these challenges by identifying necessary processes to be added or removed in the quality management system of National Institutes for Food and Drug Control, developing effective SOPs, proposing practical measures to strengthen supervision and management, and integrating 6S management principles into our quality management system. In conclusion, effective management of laboratory animal waste should be centered on improving the quality management system, emphasizing waste classification and management at the source, controlling biological hazards, minimizing environmental pollution and promoting conditions for sustainable development.

The animal laboratory of pharmaceutical and biological product inspection and testing institutions undertakes important basic support tasks for testing and scientific research work.This article summarizes the management experience accumulated in the operation of our institution's CNAS-CL06 quality management system,providing reference for similar institutions in operation to ensure the scientific nature of animal experimental data.In order to ensure the scientific nature of animal experimental data,the experimental animal institution has successfully passed the CNAS accreditation of the experimental animal institution,and has completed rectification on time during on-site supervision and evaluation.At the same time,regular self inspections of the system have been carried out in accordance with the"Quality and Capability Accreditation Guidelines for Experimental Animal Breeding and Use Institutions"(CNAS-CL06).During the self inspection process,we examined issues while improving the content of the system.Starting from animal procurement,occupational health and safety,animal disease treatment and care,and facility operation emergency drills,we enriched the content of the quality management system,ensured the continuous and effective operation of the system,and ensured the effectiveness and standardization of animal experiment data.At the same time,we contributed to the management ideas of our institution in sharing animal experiment platforms,provide hardware and software support for the construction of cloud platforms for animal experiments.This article aims to explore and form a quality management model for the experimental animal industry based on practical work,being focused in the standardization strategy,continue to deepen the reform of standardization work,and give full play to the basic and strategic role of standardization in the modernization of the animal experiments system.

Diabetic patients with poor glycemic control are exposed to media containing mold spores, and spores enter the body, which may lead to refractory infections. This article combines case and literature reviews, proposes the diagnosis and treatment method of mold infection, and provides some guidances for subjects who long-term exposure to mold groups such as farmers and immunocompromised people.

Objective To analyze the result of proficiency testing(PT)of detection activities for Laboratory animal pathogenic bacteria in 2011 and 2013-2017. To further improve the detection capacity of laboratory animal testing agency,and promote PT to be carried out in future. Methods During the six years(2011 and 2013 -2017), the National Institutes for Food and Drug Control conducted a total of six(seven projects)PT activities of laboratory animal pathogen bacteria. We analyzed the overall trend and the exposed problems by summarizing the result data of the PT in 6 years. Results A total of 45 laboratories in the country including 20 provinces and cities participated in the PT. The PT projects included Mycoplasma pulmonis, Clostridium piliformis, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella spp.,Klebsiella pneumoniae and Bordetella bronchiseptica. The satisfaction rates were 75%,87.5%,80.0%, 78.6%,93.3,96.2% and 88.0%, respectively. The main reasons of unsatisfactory results were for lack of incubation time,select errors of suspicious bacteria, biochemical identification errors, report writing errors and not timely feedback results. Conclusions The level of domestic laboratory animal pathogenic bacteria detection is gradually increased to achieve the desired goal through continuous proficiency testing activities.

Objective To establish and preliminarily apply an effective PCR assay for detection of Tupaia(tree shrew)paramyxovirus(TPMV). Methods Using TPMV genomic DNA from NCBI GenBank, bases 8231 to 8720 were synthesized and inserted into a plasmid as a positive standard. One primer pair was designed based on this sequence. In total,60 respiratory swabs and 12 lung tissues from the tree shrews were tested in this PCR assay. Results A PCR method for detection of TPMV was successfully established,with high specificity and sensitivity of 11.5 × 10 -5μg/mL. PCR result testing 60 respiratory swabs and 12 lung tissues were negative. Conclusions PCR for detecting TPMV has good specificity and high sensitivity and can be used for conventional tree shrew paramyxovirus detection.

Objective To study the relationships between differences in tumorigenicity and immu-nogenetic backgrounds of nude mice. Methods According to the Chinese Pharmacopoeia, positive and neg-ative groups were set up in both Laboratory A and B with ten nude mice in each group. Organ tissues were collected for clinicopathological analysis. Blood samples were collected and detected using flow cytometry. DNA was extracted and analyzed with 23 STR markers. Results The positive group of Laboratory B was in-valid (7/10 tumor formation). The two laboratories showed no significant difference in the results of patho-logical analysis, but had significant differences in CD25, CD8, CD4, Th1 and Th2. There were 13 and 18 polymorphic sites respectively found in nude mice of Laboratory A and B. Further analysis of the non-tumor-bearing nude mice in Laboratory B positive group revealed that CD25, Th2, D3Mit29 and D5Mit48 were the specific indexes. Conclusion Differences in tumorigenicity might be related to the diversity of immunoge-netic backgrounds of nude mice.

Objective We established a rapid detection method of Pasteurella spp.and provided a reference for microbiological quality control of laboratory animal .Methods According to the β subunit of bacterial RNA polymerase ( rpoB) protein multiple alignments of 13 different Pasteurella spp.published in NCBI .The degenerate primers were designed by CODEHOP designer online .CODEHOP PCR method was applied to detecting Pasteurella spp.after the specificity and sensitivity of the method had been evaluated by 21 reference strains .Results Standard strain amplified fragment were about 200 bp by degenerate primers PastF6/PastR5.The primers are able to distinguish between Pasteurella spp.and the other pathognic organisms of laboratory animal respiratory tracts .Sensitivity of this method were 0.2 pg/μL~2 pg/μL to different Pasteurella.The Pasteurella positive rate was 19.1% in 609 animal ' s respiratory samples .The accuracy of positive results was 100%through verifying by sequenced and blast .Conclusions The established method has good specificity and sensitivity .It can be used to detect Pasteurella spp.in animal samples .

Objective To compare and analyze the genetic structure of NIH mice bred in Unites A and B, using microsatellite technology.Methods Thirty SPF 8-week old outbred NIH mice (half male and half female) of each population were randomly chosen from the Units A and B, respectively.PCR amplification and STR scan were performed to determine the genetic characteristics of two outbred populations using microsatellite loci, and the population genetic structure was analyzed with statistical software Popgene 1.32.Results In the NIH mouse population form the Unit A, 74 alleles were obtained, with an average heterozygosity of 0.3108 and polymorphism information content of 0.2637.In the NIH mouse population from the Unit B, 76 alleles were obtained, with an average heterozygosity of 0.3257 and polymorphism information content of 0.2777.The inter-population comparison showed that genetic differentiation coefficient Fst was 0.3932, the genetic identity was 0.3971, and the genetic distance was 0.9235.The population difference was significant.Conclusions There is serious genetic differentiation between the two NIH mice populations,resulting in the formation of two different closed populations.

Objective To screen the markers of chromosome 12, which is vacant in the Beijing local standard DB11/T828.3-2011 for genetic quality control of miniature pigs in Beijing, and to study the applicability of the local standard by comparison of two different methods for evaluation of the genetic quality of the same population.Methods According to the literature, we selected four pairs of microsatellite markers of chromosome 12 and studied the polymorphism through monitoring the genetic quality of two populations of China Agricultural University miniature pigs.We screened the highly polymorphic markers of chromosome 12, combined them with the microsatellite primers of the standard 18 pairs of chromosomes to establish the whole chromosome method.We compared and analyzed the applicability of the local standard DB11/T828.3-2011 through monitoring the genetic quality of the same population of miniature pigs with different method.The data were processed and analyzed using software Popgen32.Results All the screened four pairs of microsatellite markers of chromosome 12 were highly polymorphic (PIC>0.5).The local standard showed a chromosome coverage of 94.7%, stability of amplification of 96.0%, and certified that the China Agricultural University miniature pig III was qualified, while the China Agricultural University miniature pig I was not qualified.When the markers of chromosome 12 were added, the whole chromosome method showed result of 100% chromosome coverage and 96.6% amplification stability, both of the two populations of pigs were certified as qualified.Conclusions The four screened markers of chromosome 12 are all highly polymorphic, and provide a support for supplement of the local standard DB11/T828.3-2011.

Objective To establish a rapid, simple, sensitive, and specific multiplex real-time PCR method for quantitative detection of Campylobacter jejuni, Salmonella and Shigella in tree shrews.Methods Specific primers and probes were designed, according to the HipO gene of Campylobacter jejuni, inV gene of Salmonella and ipaH gene of Shigella.The primers were confirmed by single pathogen quantitative PCR, and the sensitivity and specificity of the multiplex PCR were analyzed.Finall, the samples of experimental tree shrews were detected by this multiplex PCR method.Results The PCR element of TaqMan-MGB real-time PCR assay was able to quantitatively amplify the Campylobacter jejuni, Salmonella or Shigella.Appropriate standard amplification curves of Campylobacter jejuni, Salmonella and Shigella in the multiplex quantitative PCR were obtained.The sensitivity of this method was 1×103 ng/μL.There was no false positive detection from other bacterial strains.Conclusions This multiplex quantitative real-time PCR method has good application and development prospects in the detection of microorganisms in tree shrews.