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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.

Background: In China, female sex workers (FSWs) are at high risk of syphilis infection, but are hard to reach for interventions. Point-of-care testing introduces opportunities for expanding syphilis control measures. Modelling is used to estimate the impact of using rapid tests to screen FSWs for syphilis. In other settings, modelling has predicted large rebounds in infectious syphilis following screening, which may undermine any impact achieved., Methods: A deterministic syphilis transmission model among FSWs and clients was fitted to data from Yunnan Province (FSW syphilis prevalence = 7.5%), and used to estimate the impact of rapid syphilis testing and treatment for FSWs. Impact projections were compared for different model structures that included risk heterogeneity amongst FSWs, incoming syphilis infections amongst new FSWs and clients and re-infection from FSWs' regular non-commercial partners. The rebound in syphilis prevalence after screening ceased was explored., Results: All model structures suggest yearly syphilis screening could substantially reduce (by 72-88%) syphilis prevalence amongst FSWs in this setting over five years. However, incoming syphilis infections amongst new FSWs and clients or re-infections from regular non-commercial partners of FSWs can considerably reduce (>30%) the proportion of infections averted. Including heterogeneity in risk amongst FSWs had little effect upon the proportion of infections averted. In this setting, the rebound in syphilis prevalence after screening ceased is predicted to be slight, but it could be large in high prevalence settings., Conclusions: Rapid test screening could dramatically reduce syphilis prevalence amongst hard-to-reach groups, but strategies to reduce re-infection from regular non-commercial partners are needed to maximise impact.

Background: Syphilis is a major public health problem in many regions of China, with increases in congenital syphilis (CS) cases causing concern. The Chinese Ministry of Health recently announced a comprehensive 10-y national syphilis control plan focusing on averting CS. The decision analytic model presented here quantifies the impact of the planned strategies to determine whether they are likely to meet the goals laid out in the control plan., Methods and Findings: Our model incorporated data on age-stratified fertility, female adult syphilis cases, and empirical syphilis transmission rates to estimate the number of CS cases associated with prenatal syphilis infection on a yearly basis. Guangdong Province was the focus of this analysis because of the availability of high-quality demographic and public health data. Each model outcome was simulated 1,000 times to incorporate uncertainty in model inputs. The model was validated using data from a CS intervention program among 477,656 women in China. Sensitivity analyses were performed to identify which variables are likely to be most influential in achieving Chinese and international policy goals. Increasing prenatal screening coverage was the single most effective strategy for reducing CS cases. An incremental increase in prenatal screening from the base case of 57% coverage to 95% coverage was associated with 106 (95% CI: 101, 111) CS cases averted per 100,000 live births (58% decrease). The policy strategies laid out in the national plan led to an outcome that fell short of the target, while a four-pronged comprehensive syphilis control strategy consisting of increased prenatal screening coverage, increased treatment completion, earlier prenatal screening, and improved syphilis test characteristics was associated with 157 (95% CI: 154, 160) CS cases averted per 100,000 live births (85% decrease)., Conclusions: The Chinese national plan provides a strong foundation for syphilis control, but more comprehensive measures that include earlier and more extensive screening are necessary for reaching policy goals.

Background: Appropriate diagnostics to monitor disease trends and assess the effectiveness and impact of interventions are essential for guiding treatment strategies at different thresholds of schistosomiasis transmission and for certifying elimination. Field validation of these assays is urgently needed before they can be adopted to support policy decisions of the national programme for control and elimination of schistosomiasis in P.R. China. We compared the efficacy and utility of different immunoassays in guiding control strategies and monitoring the endemic status of S. japonicum infections towards elimination., Methodology/principal Findings: A cross-sectional survey was conducted in seven villages with different transmission intensities settings to assess the performance and utility of three immunoassays, e.g., an indirect hemagglutination assay (IHA&#95;JX), an enzyme linked immunosorbent assay (ELISA&#95;SZ), and a dot immunogold filtration assay (DIGFA&#95;SH). 6,248 individuals aged 6-65 years old who gave consent and supplied their stool and blood samples were included for data analysis. Results showed that ELISA&#95;SZ performed significantly higher sensitivity (95.45%, 95%CI: 92.94-97.97%) than IHA&#95;JX (87.59%, 95%CI: 83.51-91.49%) and DIGFA&#95;SH (79.55%, 95%CI: 74.68-84.41%), especially in subgroups with very low infection intensity. The specificity of ELISA&#95;SZ, IHA&#95;JX, DIGFA&#95;SH in 6-9 year olds with occasional exposure was nearly 90%. DIGFA&#95;SH performed the highest screening efficacy for patients among three assays with overall positive predicative value of 13.07% (95%CI: 11.42-14.72%). We found a positive correlation of antibody positive rate of IHA&#95;JX with results of stool examination in age strata (r = 0.70, P<0.001). Seropositivity of IHA&#95;JX in children aged 6-9 years old showed an excellent correlation with prevalence of schistosome infection in the seven communities (r = 0.77, P<0.05)., Conclusions/significance: Studies suggest that ELISA&#95;SZ could be used to guide selective chemotherapy in moderate or low endemic regions. IHA&#95;JX could be used to as a surveillance tool and for certifying elimination of schistosomiasis through monitoring children as a sentinel population.

China has experienced an increasing epidemic of sexually transmitted infections (STIs), including HIV. High risk groups likely to be infected include female sex workers (FSWs) and their clients, men who have sex with men (MSM), drug users and migrant workers. Prevention can be achieved through education of the population, condom promotion, early detection of symptomatic and asymptomatic people, and effective diagnosis and treatment of these patients and their partners. This article aims to describe the profile of the epidemic in high-risk groups in China as well as to detail the contributing factors and the implications for control. Programmes for the control of STIs should be immediate priorities in China, and primary and secondary prevention strategies are vital to this process.

Background: The dipstick dye immunoassay (DDIA), recently commercially available in the People's Republic of China (P.R. China), is a rapid and simple test to detect human antibodies against Schistosoma Japonicum. Its performance and utility for screening schistosome infection in low endemic areas is little known. We therefore carried out a cross-sectional survey in seven villages with low endemicity of schistosomiasis in P.R. China and assessed the performance and utility of DDIA for diagnosis of schistosomiasis. Stool samples were collected and examined by the Kato-Katz method and the miracidium hatching technique. Serum samples, separated from whole blood of participants, were tested by DDIA., Results: 6285 individuals aged 6-65 years old participated in this study, with a prevalence of schistosomiasis of 4.20%. Using stool examination as a gold reference standard, DDIA performed with a high overall sensitivity of 91.29% (95% CI: 87.89-94.69%) and also a high negative predictive value, with a mean value of 99.29% (95% CI: 98.99-99.58%). The specificity of DDIA was only moderate (53.08%, 95% CI: 51.82-54.34%). Multivariate analysis indicated that age, occupation and history of schistosome infection were significantly associated with the false positive results of DDIA., Conclusions: DDIA is a sensitive, rapid, simple and portable diagnostic assay and can be used as a primary approach for screening schistosome infection in areas of low endemicity. However, more sensitive and specific confirmatory assays need to be developed and combined with DDIA for targeting chemotherapy accurately.

Background: With a national program initiated recently to reduce transmission of Schistosoma japonicum in the People's Republic of China (P.R. China), there is an urgent need for accessible, quality-assured diagnostics for case detection, surveillance, and program monitoring of chemotherapy efficacy and other control interventions in areas of low endemicity. We compared the performance of nine immunodiagnostic tests developed in P.R. China for detection of antibodies against S. japonicum and established their priority for further assessment in field settings., Methodology/principal Findings: Using the Kato-Katz technique as the reference standard, 240 well-characterized archived serum specimens (100 positive and 140 negative) were evaluated in nine immunological tests developed in P.R. China. The enzyme-linked immunoelectrotransfer blot assay (EITB), which uses an adult worm extract of S. japonicum, supplied by the Center of Disease Control and Prevention, USA, was also evaluated. The sensitivity and specificity of each test were determined and the reproducibility of each test was assessed by evaluating operator-to-operator and run-to-run variation. In addition the simplicity of use for the end-user was evaluated. All tests showed good sensitivities ranging from 92.0% (95% confidence interval (CI): 86.7-97.3%) to 98.0% (95% CI: 95.3-100.0%). The test specificities varied from 70.0% (95% CI: 62.4-77.6%) to 97.1% (95% CI: 94.4-99.9%). All tests showed excellent reproducibility with a discordant rate in the range of 0-10.0% for operator-to-operator variation and run-to-run variation. All tests, except one magnetic particle-based enzyme-linked immunosorbent assay, were found to be easy to use, especially the dot immunogold filtration assays., Conclusions/significance: Most evaluated tests had acceptable performance characteristics and could make an impact on the schistosomiasis control programs in P.R. China. Three tests with the highest sensitivity, specificity and greatest ease of use, were selected for further evaluation in field settings.

China is experiencing a syphilis epidemic of enormous proportions. The regions most heavily affected by syphilis correspond to regions where sexually transmitted HIV infection is also a major public health threat. Many high-risk patients in China fail to receive routine syphilis screening. This missed public health opportunity stems from both a failure of many high-risk individuals to seek clinical care and a disconnect between policy and practice. New point-of-care syphilis testing enables screening in non-traditional settings such as community organizations or sex venues. This paper describes the current Chinese syphilis policies, suggests a spatiotemporal framework (based on targeting high-risk times and places) to improve screening and care practices, and emphasizes a syphilis control policy extending beyond the clinical setting.

Background: China is experiencing a growing syphilis epidemic. Individuals are currently screened and cases are confirmed using traditional serological testing methods., Methods: A total of 11 558 serum specimens from patients at 14 sexually transmitted diseases (STD) clinics at provincial, prefecture and county levels in Guangxi Autonomous Region were tested at local clinics using the toluidine red unheated serum test (TRUST) and the SD Bioline Syphilis 3.0 Treponema Pallidum (SD-TP) test and then transported to the National STD Reference Laboratory for TRUST and confirmatory Treponema pallidum particle assay (TPPA) testing., Results: In local clinics, 13.2% of specimens were TRUST positive and 12.8% were TRUST and SD-TP positive. At the Reference Laboratory, 15.4% of specimens were TRUST positive and 11.8% were TRUST and TPPA positive. Local clinics showed a significantly higher prevalence of active syphilis compared with results from the Reference Laboratory (12.8 v. 11.8%, chi(2) = 4.59, P = 0.03). The local TRUST tests had consistent results with Reference Laboratory tests qualitatively among 96.2% of the specimens and quantitatively among 95.5% of the specimens. The algorithm of TRUST screening and then SD-TP confirmation among positive TRUST specimens at local STD clinics had 96.6% sensitivity and 99.3% specificity in diagnosing active syphilis compared with the 'gold standard' based on TRUST and TPPA positivity at the Reference Laboratory (positive predictive value 95.1% and negative predictive value 99.5%)., Conclusion: The TRUST screening and SD-TP confirmation in combination can be used at local STD clinics for the efficient diagnosis of serologically active syphilis. However, continuing capacity building and quality assurance remain critical in ensuring the quality of syphilis diagnosis at local clinics.

This was one of the first epidemiological studies in China focused on genital Chlamydia trachomatis serotype distribution in high-risk female populations using omp1 gene-based restriction fragment length polymorphism analysis. One thousand seven hundred seventy cervical swab samples from women attending sexually transmitted disease clinics and female sex workers in six cities in China (Shenzhen and Guangzhou in southern China, Nanjing and Shanghai in eastern China, and Nanning and Chengdu in southwestern China) were subjected to serovar genotyping. The proportion of omp1 genes successfully amplified in 240 C. trachomatis plasmid-positive samples was 94.2% (226/240). Serotypes E (n = 63; 27.9%), F (n = 53; 23.5%), G (n = 28; 12.4%), and D (n = 25; 11.1%) were most prevalent. Though there was no significant difference in the geographic distribution of C. trachomatis, serotype E was predominant in the South (32.1%) and East (27.1%), while serotype F was predominant in the Southwest (28.3%). Serotype F infection was associated with young age and single status. Serovar G was associated with lower abdominal pain; 47.5% of asymptomatic patients were infected with serovar E. These results provide information on distribution of genital C. trachomatis serotypes among high-risk women in China and indicate that high-risk women, including those who are asymptomatic, can be infected with multiple serovars of C. trachomatis, revealing exposure to multiple sources of infection. Although the scope for generalizations is limited by our small sample size, our results showing clinical correlations with genotypes are informative.

Objectives: To determine the performance of a rapid Chlamydia trachomatis (CT) test (Clearview Chlamydia MF) compared to the current "gold standard" (Roche Amplicor CT assay) test, and to assess acceptability of the tests to patients., Methods: A total of 1497 women at sexually transmitted diseases (STD) clinics or re-education centres in six urban cities (Shanghai, Nanjing, Shenzhen, Guangzhou, Chengdu and Fuzhou) in China participated in the study. Three vaginal and three cervical swabs were collected from each participant. Rapid CT tests were performed locally on the first vaginal and cervical swabs and the results were read independently by two staff members. The second and third swabs were randomised for performing the Roche CT assay at the National STD Reference Laboratory. Acceptability of the rapid tests to patients was determined by asking patients in clinics about their willingness to wait for the results., Results: The prevalence of CT was 13.2% (197/1497), as determined by the Roche assay with cervical specimens. CT was detected in 78 vaginal and 127 cervical specimens by the rapid test and the positive rates determined with cervical specimens were significantly higher than those with vaginal specimens (p<0.001). There was good agreement between the results read by two independent staff for either vaginal or cervical specimens (both kappa = 0.98, p<0.001). Sensitivities for vaginal and cervical specimens were 32.8% and 49.7%, respectively, and specificities were 99.2% and 97.9%, respectively. The positive predictive value was 85.7% for vaginal and 78.4% for cervical specimens. The vast majority of the patients (99.1%) were willing to wait up to two hours for the results., Conclusion: Clearview Chlamydia MF, while yielding a rapid result and requiring minimal laboratory facilities, had unacceptably low sensitivity compared to a nucleic acid amplification test. Rapid tests yielding results within one hour are generally accepted by the clients.

Objectives: To study the causes of pelvic inflammatory disease (PID) in Shenyang, Northeastern China, and to assess the efficacy of the syndromic management flowchart for PID recommended by World Health Organization (WHO)., Methods: 200 outpatients with PID attending Gynaecologic Clinic of No. 1 and No. 2 hospital of China Medical University in Shenyang, and 155 control women without symptoms underwent pelvic examination, and were tested for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma hominis (MH), bacterial vaginosis (BV), Candida albicans (CA) and Trichomonas vaginalis (TV)., Results: In PID patients, the prevalence of MH was 26%, of BV 26%, of CT 16%, of CA 11%, of TV 4% and of NG 2.5%. In the control population, prevalences were 5.2%, 8.4%, 0%, 5.2%, 0.7%, 0% respectively. MH, BV and CT were significantly more common in PID patients than in controls (P<0.01). One hundred and thirty-seven of the 200 patients with PID (68.5%) returned for follow-up. Symptoms had resolved completely in 64 (47%), and had improved in 68 (50%). There was no improvement in five (4%)., Conclusions: The management protocol for female lower abdominal pain recommended by WHO is effective in this setting.

Objectives: 1. To determine the aetiologies of genital ulcers in China. 2. To evaluate a modified WHO syndromic management algorithm for genital ulcer disease (GUD)., Methods: Patients with genital ulcers were enrolled at their first visit to STD clinics in the cities of Shanghai and Chengdu. They were managed according to a modified WHO algorithm for GUD, in which no treatment was given for chancroid. A multiplex polymerase chain reaction was used to detect Treponema pallidum, Herpes simplex and Haemophilus ducreyi. Dark field examination and serology (rapid plasma reagin and Treponema pallidum particle agglutination assay (TPPA) were also used to diagnose syphilis., Results: A total of 227 male and female patients were enrolled. Syphilis alone was diagnosed in 78 (35%), genital herpes alone in 43 (19%), and both infections were present in 28 (12%). No diagnosis was made in 76 (34%). No case of chancroid was identified. The sensitivity of the algorithm for syphilis and herpes was 88.7% and 69.0% respectively, the specificity 95.0% and 50.0%. 12/106 cases of syphilis were incorrectly classified as herpes (11%), and did not receive treatment. More than 97% of patients followed up responded clinically to treatment., Conclusion: Further validation and revision of the WHO flowchart for GUD are needed.