African swine fever(ASF)is an acute,febrile,and highly fatal disease caused by African swine fever virus(ASFV)in pigs.Given the current lack of commercial vaccines and the continu-ous evolution of ASFV in recent years,the emergence of moderately virulent genotype Ⅱ strains and the introduction of genotype Ⅰ attenuated strains have led to persistent and chronic infections in pigs.Therefore,the detection of specific antibodies against ASFV has become imperative.In this study,we established a competitive chemiluminescence immunoassay(p30-cCLIA)for detecting ASFV p30 antibodies using p30 monoclonal antibodies.By detecting sera with clear negative and positive backgrounds,we determined that the Cut-off value of this method was 50％,with both di-agnostic sensitivity(Dsn)and diagnostic specificity(Dsp)reaching 100％.Under optimal reaction conditions,we screened out an enzyme-labeled stabilizer suitable for p30 monoclonal antibody 16-5E7E8-HRP.Furthermore,the sensitivity of the established p30-cCLIA method was higher than that of the commercial blocking ELISA kit(1∶2 048 vs 1∶512)and exhibited good repeatability.Detection of sera positive for other porcine virus infections showed no cross-reactivity.The estab-lishment of this method provides a powerful tool for early diagnosis of ASF.

African swine fever(ASF)is an acute,febrile,and highly fatal disease caused by African swine fever virus(ASFV)in pigs.Given the current lack of commercial vaccines and the continu-ous evolution of ASFV in recent years,the emergence of moderately virulent genotype Ⅱ strains and the introduction of genotype Ⅰ attenuated strains have led to persistent and chronic infections in pigs.Therefore,the detection of specific antibodies against ASFV has become imperative.In this study,we established a competitive chemiluminescence immunoassay(p30-cCLIA)for detecting ASFV p30 antibodies using p30 monoclonal antibodies.By detecting sera with clear negative and positive backgrounds,we determined that the Cut-off value of this method was 50％,with both di-agnostic sensitivity(Dsn)and diagnostic specificity(Dsp)reaching 100％.Under optimal reaction conditions,we screened out an enzyme-labeled stabilizer suitable for p30 monoclonal antibody 16-5E7E8-HRP.Furthermore,the sensitivity of the established p30-cCLIA method was higher than that of the commercial blocking ELISA kit(1∶2 048 vs 1∶512)and exhibited good repeatability.Detection of sera positive for other porcine virus infections showed no cross-reactivity.The estab-lishment of this method provides a powerful tool for early diagnosis of ASF.

To explore the law and characteristics of adverse events of medical devices and to provide research methods and basis for reducing the recurrence of similar adverse events, we collect medical devices safety information from five representative countries in the world, and make statistics and analysis on the types of events, the types of management and the causes of events. The results show that among 136 serious adverse events, the top three causes of recall are product design factors, software factors, and component defects. In order to reduce the application risk of medical devices, it is suggested that product designers, operating users and medical institutions should correctly implement the monitoring and evaluation system of medical devices.
Equipment Safety ; Equipment and Supplies/adverse effects* ; Product Surveillance, Postmarketing ; Software

Objective To explore optimum cycle of Automatic Washer Disinfector for endozime auto wash triple plus with advanced proteolytic action to ensure mechanical cleaning quality and improve safety of reusable medical instruments. Methods Visual inspection, STF cleaning efficacy monitoring test and Adenosine Triphosphate (ATP) test were used to verify cleaning quality of the newly updated No.4 automatic washer disinfector, and changed key parameters on weekly basis, such as pre-cleaning temperature, pre-cleaning time, detergent concentration, main cleaning temperature, and main flushing time, recorded cleaning results for three weeks:Group test of initial procedure, Group test 1 of optimization procedure and Group test 2 of optimization procedure.Χ2 test was used to compare differences of the three groups and determine the optimum cycle. Results Group test 2 of optimization procedure had the highest visual inspection and ATP test qualification rate (both were 100.00%), and pass all the STF tests. Cleaning quality was significantly better than the other two groups, and the cycle made full use of the tested detergent. Conclusions Cycle parameters of cleaning machine have great impact on medical instruments cleaning quality; Specific consuming products need to be verified to determine the optimum cleaning cycle.

This investigation with questionnaires is about the recognition of ethical issues involved in therapeutic cloning and human embryo managemeat, and its aim is to provide basis for working out ethical guidelines of therapeutic cloning and human embryo management. The investigation has been carried out among professionals in the field of obstetrics, gynecology, and reproductive medicine in the east and west parts of our country including 12 third grade hospitals in Shanghai and Xi'an and 20 maternal and child health stations at the district and county levels with randomized sampling and voluntarily billing the questionnaires without name. A total of 400 feedbacks have been received. The results show that 91. 25% of the investigated persons admit researches on therapeutic cloning, and that majority of them recognize that moral status of embryos develops and changes in accordance with the different stages of embryo development, and put forward some recommendations to strengthen the researches on therapentic cloning and the management of human embryos in order to protect the human dignity and support the researches on therapeutic cloning.