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Objectives: Screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) at both urogenital and extragenital sites has been recommended in many countries. Testing of the infections using pooled specimens from urogenital and extragenital sites offer the opportunity to shorten the testing time and reduce the testing cost. Ex-ante pooling is placing the original single-site specimens in a tube with transport media, while ex-post pooling is making a pool of the transport media from both anorectal and oropharyngeal specimens and the urine. This study aimed to conduct a multisite performance evaluation of two pool-specimen approaches (ex-ante and ex-post) in detection of CT and NG using the Cobas 4800 platform among men who have sex with men (MSM) in China., Design: Diagnostic accuracy study., Setting, Participants and Outcome Measures: Participants were recruited from MSM communities at six cities in China. Two oropharyngeal and anorectal swabs collected by clinical staff and 20 mL first-void urine collected by the participant himself were used for evaluating sensitivity and specificity., Results: A total of 1311 specimens were collected from 437 participants in six cities. The sensitivities of ex-ante pooling approach as compared with single-specimen approach (reference standard) were 98.7% (95% CI, 92.7% to 100.0%) for detection of CT and 89.7% (95% CI, 75.8% to 97.1%) for NG, and the specificities were 99.5% (95% CI, 98.0% to 99.9%) and 98.7% (95% CI, 97.1% to 99.6%), respectively. The sensitivities of ex-post pooling approach were 98.7% (95% CI, 92.7% to 100.0%) for CT and 100.0% (95% CI, 91.0% to 100.0%) for NG, and the specificities were 100.0% (95% CI, 99.0% to 100.0%) and 100.0% (95% CI, 99.1% to 100.0%), respectively., Conclusions: The ex-ante and ex-post pooling approaches show good sensitivity and specificity in detecting urogenital and extragenital CT and/or NG, indicating that these approaches can be used in epidemiological surveillance and clinical management of CT and NG infections, particularly among MSM population., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: We aimed to evaluate the clinical performance of the GeneXpert ® (Xpert) CT/NG assay for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using urine and cervical swabs collected from patients in China., Methods: This study was conducted from September 2016 to September 2018 in three Chinese urban hospitals. The results from the Xpert CT/NG test were compared to those from the Roche cobas ® 4800 CT/NG test. Discordant results were confirmed by DNA sequence analysis., Results: In this study, 619 first void urine (FVU) specimens and 1,042 cervical swab specimens were included in the final dataset. There were no statistical differences between the results of the two tests for the detection of CT/NG in urine samples ( p  > 0.05), while a statistical difference was found in cervical swabs ( p  < 0.05). For CT detection, the sensitivity and specificity of the Xpert test were 100.0% (95%CI = 96.8-99.9) and 98.3% (95%CI = 96.6-99.2) for urine samples and 99.4% (95%CI = 96.5-100.0) and 98.6% (95%CI 97.5-99.2) for cervical swabs, respectively. For NG detection, the sensitivity and specificity of the Xpert test were 99.2% (95%CI = 94.9-100.0) and 100.0% (95%CI = 99.0-100.0) for urine and 100% (95%CI = 92.8-100.0) and 99.7% (95%CI = 99.0-99.9) for cervical swabs, respectively., Conclusion: The Xpert CT/NG test exhibited high sensitivity and specificity in the detection of CT and NG in both urine and cervical samples when compared to the reference results. The 90-min turnaround time for CT and NG detection at the point of care using Xpert may enable patients to receive treatment promptly., Competing Interests: FT and YT are employees of Cepheid, the commercial manufacturer of the Xpert® CT/NG test. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Han, Shi, Jiang, Le, Qin, Xiong, Zheng, Tenover, Tang and Yin.)

Background: Little is known about rectal Chlamydia trachomatis (CT) infection in outpatients attending sexually transmitted disease (STD) clinics in China. In this study, we aimed to explore the clinical and epidemiologic features of rectal CT infection in this population., Methods: A cross-sectional study was conducted among patients attending STD clinics in Tianjin and Guangxi provinces of China from June 2018 to August 2020. Bivariate and multivariate logistic regression analysis were developed to explore the association of different risk factors for urogenital and rectal CT infection., Results: The prevalence of urogenital and rectal CT was 11.2% (154/1374) and 4.9% (68/1377), respectively. The rectal CT prevalence among female and male patients was 7.8% (60/767) and 1.3% (8/610), respectively. The most common genotype in urogenital CT-positive samples was genotype E (29.9%), while the most common genotype among rectal CT-positive samples was genotype J (23.4%). More than 85% (52/60) of women infected with rectal CT were co-infected with urogenital CT. About 90.0% (36/40) of women shared similar genotypes between rectal and urogenital samples. Females and patients infected with urogenital CT were deemed to be at an increased risk for rectal CT infection. A high proportion of rectal CT infection had concurrent urogenital CT infection, especially in women, and most of the co-infections were shared among the same genotypes., Conclusions: It would be prudent to encourage awareness and introduce detection tests and treatment strategies for rectal CT infection particularly in female patients visiting STD clinics in China., (© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Current point-of-care tests (POCT) for syphilis, based on the detection of Treponema pallidum (TP) total antibodies, have limited capacity in distinguishing between active and past/treated syphilis. We report the development and early evaluation of a new prototype POCT based on the detection of TP-IgA antibodies, a novel biomarker for active syphilis., Methods: The TP-IgA POCT (index test) was developed in response to the World Health Organisation (WHO) target product profile (TPP) for a POCT for confirmatory syphilis testing. Two sub-studies were conducted consecutively using 458 pre-characterised stored plasma samples in China (sub-study one, addressing the criteria for the WHO TPP), and 503 venous blood samples collected from pregnant/postpartum women in South Africa (sub-study two, addressing potential clinical utility). Performance of the index test was assessed against standard laboratory-based serology using a combination of treponemal (TPHA) and non-treponemal (rapid plasma reagin [RPR]) tests., Findings: In sub-study one, the index test demonstrated 96·1% (95%CI=91·7%-98·5%) sensitivity and 84·7% (95%CI=80·15-88·6%) specificity for identification of active syphilis (TPHA positive, RPR positive). It correctly identified 71% (107/150) samples of past-treated syphilis (TPHA positive, RPR negative). In sub-study two, the index test achieved 100% (95%CI=59%-100%) sensitivity for active syphilis and correctly identified all nine women with past syphilis., Interpretation: The TP-IgA POCT has met the WHO TPP for a POCT for diagnosis of active syphilis and demonstrated its potential utility in a clinical setting. Future studies are warranted to evaluate field performance of the final manufactured test., Funding: Saving Lives at Birth: Grand Challenge for Development, Thrasher Research Fund, and the Victorian Government Operational Infrastructure Scheme., Competing Interests: MLG, HV, DAA and SZ developed the syphilis IgA test at the Burnet Institute in Australia and DAA is also employed at Nanjing BioPoint Diagnostics, a spinoff company of the Burnet Institute, which will manufacture the final syphilis IgA POCT device. MLG, HV, DAA, SZ, MDP, YM and SL report grants from Saving Lives at Birth - A Grand Challenge for Development managed by USAID (award number AID-OAA-F-13-00,011) and from the Thrasher Research Fund via a project grant (award number: 12617). AW and KT report funding from the Burnet Institute, Australia, during the conduct of the study. MDP, YM, SL work at the Burnet Institute but were not involved in the development of the test. All other authors report no conflict., (© 2020 The Authors.)

Background: Chlamydia trachomatis (CT) infection is one of the most pervasive sexually transmitted infections and has high prevalence in urogenital and extra-urogenital sites among men who have sex with men (MSM). This study investigated anatomical site-specific prevalence and genotypes of CT among MSM recruited from three geographic areas in China., Methods: We collected urine specimens and anorectal, pharyngeal swab specimens from 379 MSM. CT infection was identified using polymerase chain reaction and CT genotyping was determined by sequences of the ompA gene., Results: The results indicated that the overall prevalence of CT infection was 18.2% (95% confidence intervals [CIs], 13.9-22.5%) and significantly different between the cities (p = 0.048). The infection was most common at the anorectal site (15.6, 95%CIs 11.6-19.5%) followed by urethral (3.2, 95%CIs 1.4-5.0%) and oropharyngeal sites (1.6, 95%CIs 0.3-2.9%). Genotypes D and G were the most common CT strains in this population but genotype D was significantly predominated in Nanjing while genotype G was in Wuhan. No genotype related to lymphogranuloma venereum was found. CT infection was significantly related to the infection of Neisseria gonorrhoeae (adjusted odds ratio [aOR] 14.27, 95%CIs 6.02-33.83, p < 0.001) and age. Men older than 40 years old were less likely to have a CT infection as compared to men under 30 years old (aOR 0.37, 95% CIs 0.15-0.93, p = 0.03)., Conclusion: The high CT infection prevalence, particularly in the anorectal site, among MSM suggests the necessity to development an integrated CT screening and treatment program specifically focusing on this high-risk population. Surveillance of CT infections should be improved by including both infection and genotype based surveys into the current surveillance programs in China.

In 2016, we identified a ceftriaxone-resistant Neisseria gonorrhoeae isolate in China. The strain genotype was identical to the resistant clone FC428 that originated in Japan. Enhanced international collaborative surveillance programs are crucial to track the transmission of the ceftriaxone-resistant clones.

Background: Tracking the spread of the Neisseria gonorrhoeae strains with decreased susceptibility or resistance to cephalosporins is a major priority for global surveillance programmes. Whole-genome sequencing (WGS) has been widely used by increasing countries in North America, Europe, and Pacific to determine the decreased susceptible or resistance determinants of Neisseria gonorrhoeae , track the spread of these determinants throughout the gonococcal population at national or regional level. However, no studies to date have examined the genomic epidemiology of gonorrhea in Asia where the antimicrobial resistant strains of Neisseria gonorrhoeae appears to have emerged before disseminating the strains globally., Methods: We obtained clinical isolates and data from the China Gonococcal Resistance Surveillance Programme (China-GRSP) from 2012 to 2013. We sequenced the genomes of 435 clinical isolates of Neisseria gonorrhoeae , including 112 (25.6%) isolates with decreased susceptibility to ceftriaxone (Cfx-DS). We assessed the association between antimicrobial resistance genotype and phenotype. We also compared our data with the whole genome data of the isolates from the USA and the UK in the GenBank., Findings: The most prevalent MLST STs in our gonococcal population were MLST ST7827 (n = 74), followed by ST7365 (n = 58), ST1600 (n = 38), ST7367 (n = 35), and ST7363 (n = 29). MLST ST1901 which was reported as the predominant ST in the US was not found in our population. A total of 2512 strains, including additional 2077 published NG strains, were further included for phylogenetic analysis. It generated two distinct lineages - lineage 1 and lineage 2. Analysis of MLST ST1901 in the database indicate that most of MLST ST1901 isolates in the lineage2.6 were Cfx-DS isolates while all isolates in the lineage 2.1 were sensitive to ceftriaxone (77/110 vs. 0/13; p < 0.001). ST1901/lineage 2.6 is a ceftriaxone resistant clone which cannot distinguished by MLST genotyping. In the isolates from our study, the MICs of ceftriaxone for ST7363/lineage 2.6 isolates ranged from 0.008-0.125 mg/L (mean ± SD; 0.054 ± 0.043 mg/L) while those for ST7363/lineage 2.8 isolates ranged from 0.032-0.250 mg/L (0.134 ± 0.085 mg/L). All ST7363/lineage 2.8 isolates contained penA mosaic alleles., Interpretation: To our knowledge, current study is the first WGS-based analysis of gonococcal population at national level in Asia. China harbors the different predominant clones associated with decreased susceptibility to ceftriaxone from those clones circulated in other regions. The findings from the study can be not only used as baseline data for future studies in China but also contributable to our understanding on spread of N . gonorrhoeae and its resistant strains at regional and global levels., Funding: The Chinese Academy Medical Sciences (CAMS) Initiative for Innovative Medicine.

Gonococcal antimicrobial resistance (AMR) has become a global threat significantly hampering the control of gonorrhea. Many socioeconomic, biological, behavioral, and programmatic factors have played an important role in driving the emergence, transmission and spread of gonococcal AMR. However, research to address these scientific and programmatic questions is limited in China. Here we propose a ROADMAP (acronym for resistance surveillance, outcomes due to AMR, antibiotic stewardship and application, diagnostic tools, mechanisms of AMR, antimicrobial assessment, and population pharmacokinetics and pharmacodynamics) plan for expanding interdisciplinary collaborations to address the research needs in China.

Background: Provider adherence to the national treatment guidelines for gonorrhea is critical to assuring effective treatment. It is also an important means of limiting antibiotic overuse, which can lead to development of resistant bacteria. The Chinese treatment guidelines recommend the monotherapy with ceftriaxone or spectinomycin in accordance with the World Health Organization guidelines for treatment of uncomplicated gonorrhea. We evaluated adherence to the guidelines among treatment providers in China., Methods: The study was a nationwide cross-sectional study. In each of the 6 geographic regions in China, at least 1 province was selected. In each selected province, cities with elevated incidence of reported gonorrhea were purposively selected. Using a questionnaire, 2121 physicians recruited from 512 different categories and levels of health sectors from July to September 2017 were investigated., Results: Of the participants, more than 99% diagnosed gonorrhea using one of the laboratory tests including Gram stain, culture, nucleic acid amplification test, or other tests. Culture was the predominant assay of the choice for the diagnosis. Of the 1890 physicians who provided information on prescription behaviors, 62.2% were not adherent to the regimens for treatment of uncomplicated gonorrhea recommended by the National Sexually Transmitted Disease (STD) Treatment Guidelines (National STD Guidelines). Physicians working in the areas located in Northern China (adjusted odds ratio [AOR], 3.06; 95% confidence intervals [CIs], 1.77-5.31), in general hospitals or departments of urology (AOR, 1.54; 95% CIs, 1.08-2.19), diagnosing more cases in the past 6 months (AOR, 1.82; 95% CIs, 1.25-2.67), or unfamiliar with the treatment regimens in the National STD Guidelines (AOR, 3.48; 95% CIs, 2.76-4.37) were significantly more likely to be nonadherent to the National STD Guidelines., Conclusions: It can be concluded from our study that nonadherence to the national guidelines and empirical treatment with high doses of ceftriaxone occurred frequently in China. Further studies on the impacts of the empirical treatment on antimicrobial resistance of gonorrhea are needed.

Background: Gonorrhea remains one of the most common sexually transmitted diseases worldwide. Successful treatment has been hampered by emerging resistance to each of the antibiotics recommended as first-line therapies. We retrospectively analyzed the susceptibility of gonorrhea to azithromycin and ceftriaxone using data from the China Gonococcal Resistance Surveillance Programme (China-GRSP) in order to provide evidence for updating the treatment recommendations in China., Methods and Findings: In this study, we included 3,849 isolates collected from patients with a confirmed positive Neisseria gonorrhoeae (N. gonorrhoeae) culture at clinic visits during the period of 1 January 2013 through 31 December 2016 in 7 provinces. Antimicrobial susceptibility testing of gonorrhea isolates using agar dilution was conducted to determine minimum inhibitory concentration (MIC). Resistance to azithromycin (RTA) was defined as MIC ≥ 1.0 mg/l, and decreased susceptibility to ceftriaxone (DSC) was defined as MIC ≥ 0.125 mg/l. The prevalence of isolates with RTA was 18.6% (710/3,827; 95% CI 17.4%-19.8%). The percentage of patients with DSC fluctuated between 9.7% and 12.2% over this period. The overall prevalence of isolates with both RTA and DSC was 2.3% (87/3,827; 95% CI 1.9%-2.8%) and it increased from 1.9% in 2013 to 3.3% in 2016 (chi-squared test for trend, P = 0.03). Study limitations include the retrospective study design and potential biases in the sample, which may overrepresent men with symptomatic infection, coastal residents, and people reporting as heterosexual., Conclusions: To our knowledge, this is the first national study on susceptibility of N. gonorrhoeae to azithromycin and ceftriaxone in China. Our findings indicate high rates of RTA and DSC from 2013 to 2016. Although dual therapy with azithromycin and ceftriaxone has been recommended by WHO and many countries to treat gonorrhea, reevaluation of this therapy is needed prior to its introduction in China.

Background: Early screening for syphilis among pregnant women and the effective treatment of maternal syphilis is fundamental to prevent congenital syphilis (CS)., Methods: We obtained data from the Shenzhen Program for Prevention of CS (SPPCS) and estimated incidence rates of CS among infants born to syphilis-seropositive women treated with different regimens or untreated for maternal syphilis., Results: A total of 4746 matched cases of syphilis-seropositive mothers and their infants were included for analyses, and 162 infants were diagnosed with CS, providing an overall incidence of 3.41% (95% confidence interval [CI], 2.91%-3.98%). Among infants born to syphilis-seropositive women who had syphilis and were adequately treated before pregnancy, the incidence was 0.22% (95% CI, .05%-.66%). There were 159 cases of CS occurring in 3519 infants born to women who were syphilis-seropositive during their pregnancies, for an incidence of 4.52% (95% CI, 3.84%-5.28%). The incidence of CS was 1.82%-11.90% lower among infants born to the women treated with early benzathine penicillin G (BPG) compared with those treated with late BPG (adjusted odds ratio [aOR], 8.06 [95% CI, 2.93-22.21]; P < .001), other antibiotics (aOR, 7.71 [95% CI, .86-69.28]; P = .068), or those untreated (aOR, 68.28 [95% CI, 29.64-157.28]; P < .001). The incidence rates were 0.22% (95% CI, .06%-.80%) and 0.59% (95% CI, .35%-1.02%) in infants born to women treated with 2 courses and 1 course of BPG, respectively, corresponding to a risk difference of 0.37% (aOR, 1.74; 95% CI, .37-8.26)., Conclusions: Treatment of syphilis-seropositive pregnant women with 1 course of intramuscular BPG before 28 gestational weeks is critical for prevention of CS., (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: The human treponematoses are important causes of disease. Mother-to-child transmission of syphilis remains a major cause of stillbirth and neonatal death. There are also almost 100 000 cases of endemic treponemal disease reported annually, predominantly yaws. Rapid diagnostic tests (RDTs) would improve access to screening for these diseases. Most RDTs cannot distinguish current and previous infection. The Dual Path Platform (DPP) Syphilis Screen & Confirm test includes both a treponemal (T1) and nontreponemal (T2) component and may improve the accuracy of diagnosis., Methods: We conducted a metaanalysis of published and unpublished evaluations of the DPP-RDT for the diagnosis of syphilis and yaws. We calculated the sensitivity, specificity, and overall agreement of the test compared with reference laboratory tests., Results: Nine evaluations, including 7267 tests, were included. Sensitivity was higher in patients with higher titer rapid plasma reagin (≥1:16) for both the T1 (98.2% vs 90.1%, P < .0001) and the T2 component (98.2% vs 80.6%, P < .0001). Overall agreement between the DPP test and reference serology was 85.2% (84.4%-86.1%). Agreement was highest for high-titer active infection and lowest for past infection., Conclusions: The RDT has good sensitivity and specificity of the treponemal and nontreponemal components both in cases of suspected syphilis and yaws, although the sensitivity is decreased at lower antibody titers., (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.)

Objectives: Antimicrobial resistance (AMR) in Neisseria gonorrhoeae is a major public health concern worldwide. This is the first nationwide study, performed within the China Gonococcal Antimicrobial Susceptibility Programme (China-GASP), regarding AMR, including ceftriaxone genetic resistance determinants, and molecular epidemiology of gonococci in China., Methods: Gonococcal isolates (n = 1257) from consecutive patients were collected at 11 sentinel sites distributed across China during 2012-13. Susceptibility to ceftriaxone, spectinomycin, ciprofloxacin and tetracycline was determined using the agar dilution method. Ceftriaxone resistance determinants penA and penB were examined using sequencing. N. gonorrhoeae multiantigen sequence typing (NG-MAST) was performed for molecular epidemiology., Results: Among isolates, 0.2% were resistant to spectinomycin, 4.4% to ceftriaxone, 42.9% to tetracyclines (high-level resistance) and 99.8% to ciprofloxacin. Among 890 sequenced isolates, 16 (1.8%) possessed a penA mosaic allele; 4 of these isolates belonged to the MDR internationally spread NG-MAST genogroup G1407 (first description in China). Non-mosaic penA alleles with an A501T mutation and an A102D alteration in porB1b were statistically associated with decreased susceptibility/resistance to ceftriaxone. NG-MAST G10339, G1424 and G1053 were associated with decreased susceptibility/resistance to ceftriaxone., Conclusions: In China, ceftriaxone and spectinomycin can continue to be recommended for gonorrhoea treatment, with the possible exception of Hainan and Sichuan provinces where ceftriaxone resistance exceeded 5% and AMR surveillance needs to be strengthened. Molecular approaches including genotyping and AMR determinant analysis can be valuable to supplement and enhance conventional surveillance of gonococcal AMR in China., (© The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Objective: To determine the laboratory-based performance and operational characteristics of three dual rapid diagnostic tests (RDTs) for testing HIV and syphilis., Methods: Three dual RDTs (SD Bioline, Chembio, and MedMira) were evaluated using 1514 serum specimens archived at laboratories or collected from clinics in China and Nigeria to determine sensitivity and specificity, with 95% confidence intervals. Concordance of testing results read by two technicians, stability of testing results read at two time points, and test operation characteristics were also assessed., Results: All three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%-99.6% for HIV and 98.3%-99.0% for syphilis, and a combined specificity ranging from 97.9%-99.0% for HIV and 97.2%-99.6% for syphilis. Concordance of testing results between two technicians and stability of testing results read within and one hour past the recommended reading period showed excellent agreement, with Kappa greater than or equal to 0.98., Conclusions: All the tests were found to be very or fairly easy to use and easy to interpret the results. Further evaluations of these dual RDTs with whole blood in field settings, and more studies on the implication of introduction of these tests in HIV and syphilis control programs are needed., (Copyright © 2015. Published by Elsevier Ireland Ltd.)

Background: Epidemics of human immunodeficiency virus (HIV) and syphilis among men who have sex with men (MSM) are major public health concerns in most parts of China. A dearth of information regarding the current trend of HIV in this hard-to-reach population in several regions including Jiangsu, coupled with the reemergence of syphilis, calls for an effort to understand the dynamics of the dual epidemic in this province., Methods: To estimate the occurrence and burden of these 2 sexually transmitted diseases and the distribution of their potential sociobehavioral correlates among MSM in Jiangsu, 2 cohort studies were conducted in Yangzhou and Changzhou cities., Results: Among 839 participants, 48% were married, 51.7% had sex with women in the last 6 months, and 25.5% did not use condoms during their last anal intercourse. The observed incidence of HIV was 13.59 and 12.62 and that of syphilis was 7.33 and 13.25 per 100 person-years among the participants of Yangzhou and Changzhou, respectively. The baseline prevalence of HIV and syphilis was 16.0% and 29.9% in Yangzhou and 13.6% and 14.9% in Changzhou, respectively., Conclusions: Considerably high incidence and prevalence of HIV and syphilis among participants and their potential bridging role in transmitting these infections to the general population in Yangzhou and Changzhou cities calls for urgent effective intervention strategies., (© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

A cross-sectional study that investigated the association between cervical infection of Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma genitalium and infection with high-risk types of human papillomavirus among female sex workers in China found that the presence of cervical C. trachomatis or M. genitalium infection was independently associated with infection with certain high-risk types of specific high-risk human papillomavirus among this population.

Background: Rapid point-of-care (POC) syphilis tests based on simultaneous detection of treponemal and nontreponemal antibodies (dual POC tests) offer the opportunity to increase coverage of syphilis screening and treatment. This study aimed to conduct a multisite performance evaluation of a dual POC syphilis test in China., Methods: Participants were recruited from patients at sexually transmitted infection clinics and high-risk groups in outreach settings in 6 sites in China. Three kinds of specimens (whole blood [WB], fingerprick blood [FB], and blood plasma [BP]) were used for evaluating sensitivity and specificity of the Dual Path Platform (DPP) Syphilis Screen and Confirm test using its treponemal and nontreponemal lines to compare Treponema pallidum particle agglutination (TPPA) assay and toluidine red unheated serum test (TRUST) as reference standards., Results: A total of 3134 specimens (WB 1323, FB 488, and BP 1323) from 1323 individuals were collected. The sensitivities as compared with TPPA were 96.7% for WB, 96.4% for FB, and 94.6% for BP, and the specificities were 99.3%, 99.1%, and 99.6%, respectively. The sensitivities as compared with TRUST were 87.2% for WB, 85.8% for FB, and 88.4% for BP, and the specificities were 94.4%, 96.1%, and 95.0%, respectively. For specimens with a TRUST titer of 1:4 or higher, the sensitivities were 100.0% for WB, 97.8% for FB, and 99.6% for BP., Conclusions:  DPP test shows good sensitivity and specificity in detecting treponemal and nontreponemal antibodies in 3 kinds of specimens. It is hoped that this assay can be considered as an alternative in the diagnosis of syphilis, particularly in resource-limited areas.

Objective: To understand the distribution of marriage status among men who have sex with men (MSM) in the city of Changzhou, and to explore the impact of marriage on AIDS related high risk behaviors and HIV infection in this population., Methods: Target sampling (snowball sampling) was adopted to carry out a cross-sectional study, and structured questionnaire-based interviews were conducted to collect information on social demography, HIV related high risk behaviors. Blood and urine samples were collected to detect HIV, syphilis, gonorrhea and Chlamydia trachomatis infections., Results: Of the 655 participants, 37.4% were married. Married MSM mostly sought their sexual partners at the public bathing house (61.6%), while unmarried MSM were mainly through bars (33.6%) or internet (31.1%). The proportion of having anal sex with men during the last 6 months was lower in the married group (50.8%) than in the unmarried group (73.3%), (P < 0.001) The percentage of having sex with women in the last 6 months was significantly higher in the married group (68.9%) than that in the unmarried group (33.2%) (P < 0.001), (OR = 4.454, 95%CI: 3.168 - 6.261). The rates of condom use in the last anal sex with men in married and unmarried groups were 71.0% and 77.6%, respectively (P = 0.152). The rate of condom use in the last intercourse with women was significantly lower in the married group (44.0%) than that in the unmarried group (70.4%) (P < 0.001), (OR = 0.331, 95%CI: 0.205 - 0.535). In the sex trade, most of the married MSM would "buy" sex (66.7%), while unmarried MSM would "sell" sex (63.2%) (P < 0.05), (OR = 3.429, 95%CI: 1.255 - 9.366). The percentage of having drugs in the previous year was higher in married group (3.3%) than that in the unmarried group (0.8%) (P < 0.05). In married and unmarried groups, the infection rates of HIV, syphilis, gonorrhea and Chlamydia trachomatis appeared to be (8.6%, 8.6%), (17.1%, 12.3%), (1.6%, 2.4%), and (3.3%, 9.0%), respectively (P > 0.05)., Conclusion: Marriage seemed to have had limited effects on reducing the high risk behaviors of MSM. Different and multiform interventions should be developed according to the different characteristics of married or unmarried MSM population.

We conducted a cross-sectional study on prevalence of human immunodeficiency virus (HIV) and syphilis among female sex workers (FSWs) recruited from different types of venues in 6 cities in China. Among 5322 FSWs (1379 were from high-tier venues, 2482 from middle-tier venues, and 1461 from low-tier venues, respectively), overall HIV prevalence was 0.54% (95% confidence interval [CI], 0.37%- 0.76%). By typology of venues where FSWs solicited clients, the prevalence was 1.37% (95% CI, 0.89%-2.11%) in low-tier venues, 0.28% (95% CI, 0.14%- 0.58%) in middle-tier venues, and 0.07% (95% CI, 0.01%-0.41%) in high-tier venues. The final logistic regression model showed an association of having had HIV infection with working in low-tier venues (adjusted odds ratio 2.73; 95% CI, 1.12-6.67) and coming from Guangxi Province (adjusted odds ratio, 7.89; 95% CI, 1.65-37.64). It can be concluded that FSWs working in low-tier venues (on the streets or public outdoor places) had higher risk of HIV infection than other venues. Such subgroup of FSWs should be efficiently covered by the current HIV/STD surveillance and intervention programs in China.

Background: Syphilis has made a rapid resurgence in China, especially among high-risk groups including female sex workers (FSWs)., Methods: Two cities in each of 3 provinces in South China were chosen and allocated to intervention or control arms. The intervention consisted of enhancing community-based syphilis screening outreach intervention with comprehensive sexually transmitted infection services at designated clinics while the control maintained routine intervention activities. Generalized linear modeling was used to examine effect of the intervention on incident syphilis infection., Results: A total of 8275 women were eligible, and 3597 women enrolled (n = 2011 in control arm, n = 1586 in intervention arm) in the study. The median follow-up duration was 375 days (interquartile range, 267–475). Syphilis incidence density in the intervention group was reduced by 70% (95% confidence interval, 53%–81%) compared with the incidence in the control arm. The syphilis prevention intervention benefits were robust among FSWs at low-tier venues, individuals with less than high school education, migrants, and women who did not report condom use during the last episode of sex., Conclusions: Integrated sexually transmitted infection and human immunodeficiency virus prevention strategies substantially reduce syphilis incidence among FSWs, especially among those at low-tier venues. This intervention suggests the need for scaling up comprehensive FSW programs in China.

Objectives: To determine the prevalence and risk factors of herpes simplex virus type 2 (HSV-2) infection and its coinfection with human immunodeficiency virus (HIV) in men who have sex with men (MSM) in China., Methods: A convenience sample of 1462 MSM were recruited from different settings (an STD clinic, a health center, and MSM venues) in 3 cities in China. Blood specimens were collected for testing for antibodies to HSV-2 and HIV to determinate the seroprevalence of HSV-2 infection and HSV-2/HIV coinfection. Information on sociodemographic and behavioral characteristics was collected to determine the risk factors associated with the infections., Results: The prevalence of HSV-2 infection in 1462 MSM was 16.0% (95% confidence interval [CI], 14.2%-18.0%), the prevalence of HIV infection in this population was 9.5% (95% CI, 8.1%-11.1%), and the rate of coinfection of HSV-2 and HIV was 3.2% (95% CI, 2.4%-4.3%). Multivariate logistic regression analysis showed that risk factors for HSV-2 infection included age older than 30 years, education level lower than senior high school, involvement in commercial sex work, and HIV-positive status. Education level lower than junior high school and history of sexual abuse were associated with HSV-2/HIV coinfection., Conclusions: The high prevalence of HSV-2 infection and HSV-2/HIV coinfection among MSM in China suggests that an increased focus on HSV control is warranted within China's prevention and intervention programs targeted toward MSM.

An increasing trend of HIV prevalence has been observed among men who have sex with men (MSM) in China. However, the prevalence and its increase varied among MSM recruited from different settings, indicating the highest prevalence and its increase among those MSM from bathhouse or sauna. The findings have important implications for surveillance and interventions in this population.

Background: There have been limited data on molecular epidemiology of syphilis in China. This study aimed to analyze strain type distribution of Treponema pallidum causing early syphilis across geographic areas in China using an enhanced method., Methods: Genital samples were collected from patients in East, South, and North China. Positive DNA of T. pallidum was analyzed by arp, tpr, and tp0548 genes., Results: Sufficient DNA for full molecular typing existed in 197 of 324 samples, and 27 strain types were identified. A range of 3 to 20 repeats (except 4, 11, and 19 repeats) and 25 repeats were found for the 60-bp tandem repeats of the arp gene. This was the first time the 9 and 25 repeats were detected. For the RFLP analysis of the tpr genes, patterns a, d, h, j, and l were identified. This was the first time the h, j, and l patterns were observed in China. For the sequence analysis of the tp0548 gene, sequences c, e, and f were identified. Strain type distribution was significantly different across geographic areas (χ² = 20.6, P = 0.006). Overall, 14d/f was most predominant (39% of fully typed samples, 95% CI = 32%-46%); 13d/f, 15d/f, and 16d/f were next most common (each 13% of fully typed samples, 95% CI = 9%-18%)., Conclusions: There is substantial genetic diversity of T. pallidum in China. The broad and ununiform distribution of strain types may reflect differences in regional sexual network patterns. Predominance of few strain types may indicate a linked transmission.

Objective: To investigate infections of syphilis, neisseria gonorrhoeae, chlamydia trachomatis and the related risk factors in men who have sex with men (MSM) in Jiangsu province., Methods: A total of 400 MSM were enrolled by Snowball Sampling Method from August to October in 2010 and then 328 cases were surveyed by a questionnaire and collected serum sample 5 ml per person as well as rectal swab on the spot; all of the serum samples were tested for syphilis by ELISA and TRUST, and all of the rectal swabs were tested for neisseria gonorrhoeae or chlamydia trachomatis. The influencing factors of syphilis, neisseria gonorrhoeae, chlamydia trachomatis were analyzed by logistic regression analysis., Results: The 328 MSM were (32.46 ± 9.72) years old, 59.15% (194/328) were unmarried.75.00% (246/328) MSM had rectal sex with men in the past 3 months, and condom use rate for recent sex was 56.71% (186/328), while 53.05% (174/328) MSM didn't have sex with women in the last 3 months. The syphilis infection rate among MSM was 13.41% (44/328), the neisseria gonorrhoeae infection rate was 3.66% (12/328), and the chlamydia trachomatis rate was 11.59% (38/328). The number of sex partners was the key factor that influenced syphilis infections (OR = 4.213, 95%CI: 1.133 - 15.656)., Conclusion: The prevalence of syphilis and chlamydia trachomatis was high in MSM in Jiangsu, while risk behavior rate were high in the MSM and then should be intervened.

Background: Antimicrobial resistance in Neisseria gonorrhoeae (NG) is a public health concern globally, and azithromycin-resistant NG isolates have been identified in many countries. This study aimed to investigate azithromycin susceptibility in NG and to genetically characterize the azithromycin-resistant isolates identified in 2 cities in China., Methods: NG isolates (n = 318) were cultured from patients attending 2 sexually transmitted infection clinics in Nanjing and Chongqing, China, between 2008 and 2009. Minimum inhibitory concentration (MIC) of azithromycin, tetracycline, ciprofloxacin, spectinomycin and ceftriaxone was determined using the agar dilution method. NG strains ATCC 49226 and WHO G, J, L, and P were used for quality control. Azithromycin-resistant isolates were defined as having an MIC value equal to or greater than that of strain WHO P, which is internationally recognized as azithromycin-resistant (MIC = 2 mg/L), and genotyped using NG multiantigen sequence typing., Results: The MIC values of strain WHO P for azithromycin were 2 to 4 mg/L in all runs, which showed that the method provided consistent and reliable MIC values. Seventeen isolates (5.3%) showed resistance to azithromycin. Among these isolates (n = 17), 11 sequence types (STs) were identified by NG multiantigen sequence typing, of which 5 were novel. The most common ST was ST3356, represented by 6 isolates. ST1866 was represented by 2 isolates, which were isolated from patients with an unknown relationship, and both isolates were highly resistant to azithromycin, i.e., displayed an MIC of >64 mg/L., Conclusions: A relatively high prevalence of azithromycin-resistant NG strains implies that azithromycin should not be recommended for the treatment of gonococcal urethritis or cervicitis in China.

Objective: To explore a new method of preventing Neisseria gonorrhea (N. gonorrhoeae) by simulating intercourse in mice and verify the effect of a long-acting antibacterial material in the gonococcal infection in mice., Methods: (1) Simulated male-female gonococcal transmission: the estradiol-treated BALB/c female mice were inoculated with N. gonorrhoeae WHO-L via a vaginal route. In treated group, the mice received the long-acting antibacterial material via vaginal route while deionized water was administered in the control group. At Days 2 - 10 post-inoculation, the average number of polymorphonuclear cells (PMNs) was monitored in stained smears of vaginal cells from test mice. And the vaginal fluid was cultured for N. gonorrhoeae at Days 2, 4, 5 post-inoculation. N. gonorrhoeae genital tract infection was determined to compare the difference between the two groups. (2) Simulated female-male gonococcal transmission: a treated or sham glass rod was used instead of male mice's penis to simulate intercourse in gonococcus-infected female mice. The vaginal fluid on top of glass top was eluted and cultured for N. gonorrhoeae and the difference of relevance ratios compared., Results: (1) In the experiment of simulated male-female gonococcal transmission, At Days 4 and 5, the positive rates of culture for N. gonorrhoeae of the tested group were lower than those of the control group, and there was significant difference between both groups (10.0% vs 57.5%, 7.5% vs 45.0%, both P < 0.01). The percentage of PMNs in the treated group was significantly lower than that of the control group at Days 5 - 8 post-inoculation (all P < 0.05). (2) In the experiment of simulated female-male gonococcal transmission, the positive rates of culture for N. gonorrhoeae from the vaginal fluid on top of glass top were 8.3% and 0 at Days 1 and 2 in the tested group respectively. And they were significantly lower than those of the control group (72.7% and 45.5% respectively, both P < 0.01)., Conclusion: After topical application in murine vagina, the long-acting antibacterial material forms a layer of physically antibacterial molecular film to prevent the occurrence of N. gonorrhoeae genital tract infection or colonization in mice. It may be used as a liquid condom for male mice.

Background: Strain typing is a tool for determining the diversity and epidemiology of infections., Methods: Treponema pallidum DNA was isolated from 158 patients with syphilis from the United States, China, Ireland, and Madagascar and from 15 T. pallidum isolates. Six typing targets were assessed: (1) the number of 60‐bp repeats in the acidic repeat protein gene, (2) restriction fragment length polymorphism (RFLP) analysis of T. pallidum repeat (tpr) subfamily II genes, (3) RFLP analysis of the tprC gene, (4) determination of tprD allele in the tprD gene locus, (5) the presence of a 51‐bp insertion between tp0126 and tp0127, and (6) sequence analysis of an 84‐bp region of tp0548. The combination of targets 1 and 2 comprises the Centers for Disease Control and Prevention (CDC) T. pallidum subtyping method., Results: Adding sequence analysis of tp0548 to the CDC method yielded the most discriminating typing system. Twenty‐five strain types were identified and designated as "CDC subtype/tp0548 sequence type." Type 14d/f was found in samples from 5 of 6 locations. In Seattle, Washington, strain types changed from 1999 through 2008 (P < .001). Twenty‐one (50%) of 42 patients infected with type 14d/f had neurosyphilis compared with 10 (24%) of 41 patients infected with any of the other types combined (P = .02)., Conclusion: We describe an enhanced T. pallidum strain typing system that shows biological and clinical relevance.

The rate of sexually transmitted infections (STIs) has soared in China. Yet, there is no universal consensus about the accuracy of the syndromic approach to STI management. This study aims to compare the syndromic approach with laboratory tests. A randomly selected sample of market vendors in eastern China (n = 4510) was recruited and assessed for the five most common STIs (Chlamydia trachomatis infection, gonorrhoea, genital herpes [herpes simplex type 2, HSV-2] syphilis and trichomoniasis [female only]). Symptom-based assessments made by physicians were compared with laboratory tests. Laboratory test results were used as the gold standard for the comparisons. The overall sensitivity of physician symptom-based assessment was about 10%; sensitivity was lower for males (1.6%) than for females (17.2%). The sensitivity of physician assessments for those who reported STI symptoms was relatively higher (36.7%) than for those who reported no symptoms (5.1%). More than half (54.37%) of the participants were diagnosed with STI of trichomoniasis. For the other four types of STIs, physicians correctly identified only <10% of the positive cases. The study detected a low sensitivity of STI diagnosis made by physicians in an Eastern city of China. The failure in the detection of asymptomatic patients remains one of the limitations of the syndromic approach.

Background: Gonorrhoea has been one of the most common sexually transmitted diseases (STDs) in China. A clear understanding of its transmission dynamics is important in formulating prevention and control measures., Goal: To investigate the distribution of opa types in patients attending at STD clinics in China and to evaluate the concordance between epidemiologic data and opa-typing results., Study Design: Opa typing was conducted for 330 Neisseria gonorrhoeae strains isolated from the patients at 4 STDs clinics in China, and the epidemiologic data were collected as well., Results: A total of 309 opa types were detected from the 330 isolates. Two hundred ninety-two opa types were unique, and 17 opa types were found in more than 1 patient. Opa typing confirmed all 9 sexual links that were revealed by epidemiologic information and further identified 9 opa clusters and 8 similar pairs., Conclusions: Opa typing is a discriminatory tool that can be used in epidemiologic studies on gonococcal infections. This technique is more powerful than epidemiologic data to identify sexual links and improve our understanding of the transmission dynamics of gonorrhoea.

Objective: To measure prevalence of syphilis among the STI clinic population in Guangxi, China, and to assess the socioeconomic and behavioural characteristics associated with the infection., Methods: We undertook a cross-sectional survey and syphilis and HIV serologic testing among 11 473 patients attending 14 community and hospital-based dermatovenereal clinics across eight cities in Guangxi between December 2004 and February 2006., Results: 1297 (11.9%) patients demonstrated positive toludine red unheated serum test and Treponema pallidum particle agglutination results with serologic testing. A total of 58% (752) of seropositive subjects presented with a genital ulcer, palmar/plantar rash or inguinal lymphadenopathy. Female sex (OR = 2.23, 95% confidence intervals (CI) = 1.69 to 3.00, p<0.001), less education (middle school, OR = 1.70, 95% CI = 1.11 to 2.62, p = 0.023; primary school or less, OR = 1.98, 95% CI = 1.13 to 3.46, p = 0.017) and high annual income (OR = 1.91, 95% CI = 1.18 to 3.10, p = 0.009 for >30 000 RMB yuan) were associated with serologically positive status. Syphilis infection was significantly more prevalent in city 2 (19.5%, OR = 3.07, 95% CI = 1.83 to 5.16, p<0.001), city 4 (16.6%, OR = 1.90, 95% CI = 1.10 to 3.28, p = 0.011) and city 8 (13.8%, OR = 1.83, 95% CI = 1.13 to 2.97, p = 0.006). A total of 40.1% (532) of infected subjects engaged in commercial sex and increased rates of the infection was associated with multiple sexual partners (OR = 1.54, 95% CI = 1.16 to 2.06, p = 0.003). A total of 1.2% (133) of participants carried laboratory markers for HIV and 1.8% (23) of patients with syphilis were positive for HIV., Conclusions: Syphilis infection has reached alarming rates in China's STI clinic population, suggesting a generalised spread of the disease through commercial sex and bridging populations. Syphilis control is deserving of China's highest priority. Universal screening for syphilis and HIV testing in STI clinics should be considered as measures for control.

Objective: To determine the prevalence of sexually transmitted infections (STIs) among women attending an antenatal clinic in urban China and to show whether reported symptoms and findings on clinical examination predicted STIs in this population., Study Design: Cross-sectional descriptive study was conducted among 504 pregnant women attending an antenatal clinic in Fuzhou, China. Structured questionnaires were used to collect demographic and behavioral information, and clinical and gynecologic examinations were performed to detect clinical signs of STIs. Blood samples, vaginal swabs, and cervical swabs were collected, respectively, to test for antibodies to syphilis, culture Trichomonas vaginalis (T. vaginalis), and perform PCR to detect Chlamydia trachomatis (C. trachomatis) and Neisseria gonorrhoeae (N. gonorrhoeae)., Results: C trachomatis was detected in 51 (10.1%), N gonorrhoeae in 4 (0.8%), T vaginalis in 16 (3.2%), and syphilis in 1 (0.2%) of the 504 pregnant women. Fifty-two (73%) of 71 women with any STI were asymptomatic. Multiple logistic regression analysis indicated that age RMB 2000 yuan (OR=3.57) were significant independent risk factors for chlamydial infection (P<0.05). The reported symptom of vaginal discharge or the clinical sign of either vaginal or cervical discharge poorly predicted infection with C trachomatis, N gonorrhoeae, or T vaginalis, with a positive predictive value <25% for each STI., Conclusion: A substantial prevalence of STIs, including a large proportion of asymptomatic infections, was found among pregnant women in the study area. These results support a strategy of screening pregnant women for bacterial STIs (followed by treatment of infections), which could be integrated into routine pregnancy care in China.

Objective: To establish a multiplex polymerase chain reaction (M-PCR) assay for simultaneous detection of pathogens causing genital ulcer disease (GUD)., Methods: Based on the gene-specific region of the following pathogens: Chlamydia trachomatis omp1/ompb, herpes simplex virus (HSV) DNA polymerase, Treponema pallidum tpp47, Haemophilus ducreyi 16s rRNA, four sets of primers were designed and an M-PCR assay was developed to detect four pathogens in one test. The assay was evaluated with diagnostic result of golden standard for each pathogen., Results: Of the 51 clinical samples, M-PCR showed slightly higher positive rate (47.1%) of HSV than cell culture (23.6%). Meanwhile, the positive rate of T. pallidum detected by M-PCR and dark-field microscopy was 19.6% (10/51) and 15.7% (8/51), respectively. Only one sample was positive for H. ducreyi and no sample was positive for C. trachomatis detected by both M-PCR assay and culture., Conclusion: This primary study indicated that M-PCR assay can simultaneously and rapidly detect the four etiologic pathogens causing GUD.

Objective: To investigate the antimicrobial susceptibility,auxotype, and plasmid profile of Neisseria gonorrhoeae isolates in China and to provide evidence for the development of treatment guideline and policy for control., Methods: Agar dilution was used to detect antimicrobial susceptibility. The auxotype was determined by GC genetic medium. The plasmid was extracted by alkaline cleavage and electrophoresed., Results: A total of 4,976 gonococcal isolates were tested in the last 8 years. The resistant rate for penicillin was 71.60% with PPNG being 15.54%. Tetracycline-resistant (TRNG) isolates accounted for 93.02% with 10.48% high level tetracycline-resistant. The resistant rate for ciprofloxacin was also relatively high (31.78%). The resistant rates for spectinomycin and ceftriaxone were 0.36% and 0.46%. The predominant auxotypes of gonococcal isolates were proto and pro(-) during 1995 - 1996 in Nanjing, accounted for 46.4% and 47.53%, 48.4% and 50.22%, respectively. There were 8 strains harboring 4.2, 5.4, 39.5 kb plasmids and 2 harboring 4.2, 4.9, 5.4, 39.5 kb plasmids in 10 PPNG strains; 2 harboring no plasmid, 28 harboring 4.2, 4.9, 5.4, 39.5 kb plasmids in 30 non-PPNG strains. The 5.4 kb plasmid of PPNG could be digested with restriction endonuclease BamHI while the 5.4 kb plasmid of non-PPNG could not., Conclusion: The gonococcal isolates were highly resistant to penicillin, tetracycline, and ciprofloxacin, while were still sensitive to spectinomycin and ceftriaxone. No significant auxotyping change was found in terms of predominant gonococcal strains in the last two years in Nanjing while 5.4 kb plasmid might be the most prevalent resistant plasmid in Nanjing.