ObjectiveTo evaluate the performance of a three-gene typing system in the determination of Treponema pallidum (Tp) genotypes.MethodsTo determine the genotypes of Tp,three targets were assessed,including the number of 60 base-pair repeats,restriction fragment length polymorphism(RFLP) pattem of tprEGJ gene after MseI digestion and the sequence of tp0548 gene.The DNA extracted from the Nichols strain of Tp served as the positive control,and that from the moist ulcer of patients with genital herpes and negative RPR or TPPA test results served as the negative control.To validate the typing method,clinical specimens were collected from the moist skin lesions of patients with primary or secondary syphilis,and subjected to the amplification of polA gene by PCR.The enhanced molecular typing system was used to determine the genotypes of Tp in Tp DNA-positive specimens.ResultsThe Nichols strain harbored a genotype of 14a/a.No amplification of any of the three target genes was found in the negative control.The arp gene,tprEGJ gene and tp0548 gene were amplified from 94.1％,91.2％ and 94.1％ of the 40 clinical specimens,and the genotype was successfully determined by the three-gene typing system for 91.2％ of the clinical Tp strains.The predominant type of arp,tprEGJ and tp0548 genes was 14 repeats,d and f,respectively in these clinical Tp isolates.ConclusionThe enhanced molecular tying method for Tp exhibits high sensitivity,specificity and discrimination potential.

ObjectiveTo investigate the prevalence of syphilis among outpatients in sexually transmitted disease (STD) clinics in Guangxi Zhnang Autonomous Region,and to assess the socioeconomic and behavioral factors associated with the infection.MethodsThe outpatients to 14 STD clinics in 8 cities of Guangxi Zhnang Autonomous Region were investigated with questionnaires by their doctors at the first visit.Venous blood samples were obtained from these outpatients and subjected to toludine red unheated serum test (TRUST) to screen for syphilis.Treponema pollidum particle agglutination (TPPA) was performed for TRUSTpositive samples.The epidemiological data were collected by using EpiData software,statistically analyzed by using SPSS13.0 software package.ResultsA total of 10 930 STD outpatients were recruited in the study,and 1297 samples were confirmed to be both TRUST and TPPA positive.The prevalence of syphilis was 11.9％ in all of the outpatients,14.3％ in female outpatients and 10.3％ in male outpatients,13.3％ in the outpatients of Zhuang nationality,and 11.4％ in those of Han nationalily.Multivariate analysis showed that syphilis was independently related to female sex[odds ratio(OR) 2.23,95％ confidence interval(CI) 1.69 - 3.00,P＜0.01 ],low educaiion level (middle school:OR 1.70,95％ CI 1.11 - 2.62,P ＜ 0.05; primary school or illiteracy,OR 1.98,95％ CI 1.13 - 3.46,P＜0.05),annual income of more than 30000 Yuan (OR 1.91,95％ CI 1.18 -3.10,P ＜ 0.01 ),commercial sex workers or having multiple sexual partners(OR 1.54,95％ CI 1.16 - 2.06,P ＜0.01 ).ConclusionsSyphilis serology should be the routine test in STD clinical settings in Guangxi region,and the intervention should be enhanced to control the prevalence of syphilis in high-risk populations.

Objective To estimate the prevalence of hepatitis C virus (HCV) infection among sexually transmitted disease (STD) clinic attendees infected with human immunodeficiency virus type 1 (HIV-1) in Guangxi Zhuang Autonomous Region.Methods Totally,11 553 blood plasma samples were collected from STD clinic attendees in Guangxi Zhuang Autonomous Region,and subjected to HIV-1 antibody screening and confirmatory testing.Enzyme linked immunosorbent assay (ELISA) was performed to detect anti-HCV antibodies in 140 anti-HIV-1 antibody-positive samples and 282 anti-HIV-1 antibody-negative samples from age-and marital status-matched attendees.Chi-square test was performed to assess the differences in the prevalence rate of HCV infection between anti-HIV-1-negative and-positive samples,and Logistic regression analysis to evaluate the risk factors for HCV and HIV co-infection.Results The positivity rate of anti-HCV antibodies was 33.57％ (47/140)among anti-HIV-1-positive samples,significantly higher than that in anti-HIV-1-negative samples (1.06％ (3/282),x2 =94.66,P ＜ 0.05).Logistic regression analysis showed a statistical increase in the prevalence of HCV/HIV co-infection in individuals reporting more than one sexual partners compared with those reporting only one sexual partner (OR =2.4,95％ CI (1.0-5.6),P =0.05),and in intravenous drug users compared with non-intravenous drug users (OR =20.8,95％ CI(5.7-76.5),P ＜ 0.05).Conclusions HCV infection appears to be associated with HIV-1 infection,and comprehensive intervention on HIV-1-infected patients may slow down HCV transmission.

Objective To make a nationwide external quality assessment of serologic tests for syphilis in China,in hope to increase the quality of syphilis serology in laboratories at different levels.Methods From 2006 to 2008,a nationwide external quality assessment scheme was conducted for serologic tests for syphilis in laboratories of some medical and healthcare facilities each year by the Reference Laboratory,National Center for Sexually Transmitted Disease Control,China Center for Disease Control and Prevention.Five quality control samples and corresponding questionnaires were sent to the participating laboratories.Tests were conducted and test results were reported within stipulated time.Subsequently,the test results were statistically analyzed by the Reference Laboratory,and the final results were fed back to all of these participants.Results From 2006 to 2008,the number of participating provinces increased from 17 to 31,and the number of participating laboratories from 23 to 145.Laboratories achieving a full score amounted to 79.9％,36.8％ and 57.6％,and those gaining a score of 80 or greater amounted to 95.7％,88.2％ and 89.7％,respectively,in 2006,2007 and 2008.Conclusion The external quality assessment scheme has enhanced the capacity of participating laboratories for syphilis serology to a certain extent from 2006 to 2008.

Objective To perform a nationwide external quality assessment for detection of Chlamydia trachomatis, and to improve the performance of laboratories in the detection of Chlamydia trachomatis. Methods Totally, 419 quality control samples were sent to tested laboratories, including 76 samples in 2007, 168 samples in 2008 and 175 samples in 2009. The laboratories were required to test the samples and report test results, within stipulated time, to the reference laboratory in National Center for Sexually Transmitted Disease (STD) Control, Chinese Center for Disease Control and Prevention. The reported results were statistically analyzed by the National Center for STD Control, who finally fed back the statistical results to all of the participants. Results The percentage increased from 84.93% in 2007 to 92.14% in 2009 for laboratories showing an 80% or more consistency with the reference laboratory in the detection of Chlamydia trachomatis from quality control samples (qualified), from 47.95% in 2007 to 70% in 2009 for those showing a 100% consistency (excellent), and dereased from 5.48% in 2007 to 0.71% in 2009 for those showing a consistency of lower than 60% (unqualified). The centralabs of provincial CDC and volunteer laboratories exhibited a satisfactory performance for the detection of Chlamydia trachomatis, while the performance of a small number of national STD surveillance sites needed to be increase. Conclusion The external quality assessment reveals a continuous improvement in the capability of detecting Chlamydia trachomatis in STD laboratories at different levels in China.

A sero-epidemiological survey on 1 833 healthy residents was carried out in 6 villages of a leprosy high-endemic area in Wenshan and Guangnan counties, Yunnan Province. The part of the residents with initially antibody-positive as well as the part of residents with initially antibody-negative have been followed up for 3 consecutive years by serology and clinical examination for studying kinetic changes of antibody to M.leprae and its relation with clinical disease. The results showed that the rates of subclinical infection of leprosy in a high-endemic area are different from village to village, and the risk of developing clinical disease does not associate with subclinical infection rate. It correlates with the number of cured accumulative leprosy cases and active cases within the village. The authors consider that in leprosy high-endemic villages, especially those cropped up new multi-bacillary leprosy cases frequently in recent years, it may be helpful to use serology to detect early leprosy cases.

Objective:To synthesize the real experiences of medical staff's organizational silence behavior.Methods:A systematic search was conducted in databases including PubMed, Web of Science, Embase, Cochrane Library, CINAHL, EBSCO, ProQuest, China National Knowledge Infrastructure, Wanfang Data, VIP, and China Biology Medicine disc, collecting qualitative studies on medical staff's experiences related to organizational silence behavior. The search period covered the establishment of the databases until June 2024. The quality of the included studies was assessed using the Joanna Briggs Institute's qualitative research quality evaluation standards, and results were integrated using an aggregative synthesis approach.Results:A total of 10 studies were included, with 65 findings summarized into 11 new categories, which were further synthesized into four overarching conclusions: organizational silence is complex, with respect and concern coexisting, many factors contribute to organizational silence, medical staff experience negative emotions as a result of organizational silence, there is a desire for recognition and support.Conclusions:The experience of organizational silence behavior among medical staff is complex. Managers should focus on this issue, encourage individuals to voice their concerns, provide diverse support mechanisms, and enhance positive experiences to reduce the prevalence of organizational silence.

The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.
China ; Equipment Reuse ; Equipment Safety ; Equipment and Supplies ; Risk Assessment ; United States

Objective To evaluate the application of Burnet Institute-made prototype IgA rapid test,a kind of point-of-care (POC) testing,in the diagnosis of early syphilis.Methods Totally,455 stored serum samples in the Reference Laboratory of Sexually Transmitted Disease,the Institute of Dermatology were used to evaluate the application of the prototype IgA rapid test (IgA-POC) in the diagnosis of early syphilis.According to resluts of Treponema pallidum hemagglutination assay (TPHA),rapid plasma reagin card test (RPR),and enzyme-linked immunosorbent assay for IgM antibodies (IgM-ELISA),these stored samples were divided into 3 groups:uninfected group,previously infected group and early active syphilis group.IgA-POC test was performed in the 3 groups to evaluate its diagnostic performance for active syphilis,and researchers were blind to the group information.Results The prototype IgA-POC test had a sensitivity of 92.6％ (147/163) for the early active syphilis group,a specificity of 72.22％ (104/144) for the previously infected group,and a specificity of 97.97％ (145/148) for the uninfected group.The total specificity of the prototype IgA-POC test was 85.27％,which met the minimum requirement of WHO for the POC test.The prototype IgA-POC test showed a significantly higher sensitivity for the diagnosis of early active syphilis compared with the IgM-ELISA (59.51％,Z =6.88,P ＜ 0.05),but a significantly lower specificity for the diagnosis of previous syphilis infection compared with the IgM-ELISA (98.61％,Z =6.18,P ＜ 0.05).Moreover,no significant difference in the specificity for the diagnosis of non-infection was observed between the prototype IgA-POC test and IgM-ELISA (Z =1.16,P =0.25).Conclusion The prototype IgA-POC test has better capacity for the diagnosis of early active syphilis compared with the IgM-ELISA,so it can be applied to the screening of early active syphilis.