Field evaluation of Standard Diagnostics' Bioline HIV/Syphilis Duo test among female sex workers in Johannesburg, South Africa

BACKGROUND:

Point-of-care tests provide immediate results with the opportunity for same-day interventions with improved public health outcomes. A dual HIV/syphilis test enables early treatment of both diseases.

METHODS:

We conducted a field evaluation of the Standard Diagnostics' SD Bioline HIV/Syphilis Duo test (SD Bioline) among female sex workers. SD Bioline was conducted on finger-prick blood according to manufacturer's instructions and compared with (i) Genscreen HIV1/2 (third generation) and Vironostika Ag/Ab (fourth generation) assays for HIV, and (ii) Treponema pallidum particle agglutination (TPPA) and rapid plasma reagin (RPR) assays for syphilis. A negative TPPA test was considered negative, a TPPA-confirmed RPR titre ≤1:4 as past infection and a TPPA-confirmed RPR titre ≥1:8 as active syphilis. Sensitivity, specificity, positive and negative predictive values were calculated.

RESULTS:

Of 263 women recruited, 14 (5.3%) declined an HIV test. Among the remaining 249 women, 187 (75.1%) were HIV positive, 51 (20.5%) had syphilis antibodies with seven (2.8%) active infections. For HIV, the sensitivity and specificity were 98.9% (95% CI 95.8% to 99.8%) and 100% (95% CI 92.7% to 100%). For syphilis, the sensitivity and specificity were 66.7% (95% CI 52.0% to 78.9%) and 98.0% (95% CI 94.5% to 99.3%). Sera with high TPPA titres were more likely to test positive.

CONCLUSIONS:

In field conditions, while the SD Bioline test has high sensitivity and specificity for HIV and high specificity for syphilis, the test has lower sensitivity for syphilis than reported from laboratory evaluations. As the dual test detects only two thirds of syphilis cases, it should only be used in areas with weak screening programmes.

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By:  Black V1, Williams BG2, Maseko V3, Radebe F3, Rees HV2, Lewis DA4.

• 1Faculty of Health Sciences, Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa Clinical Microbiology and Infectious Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
• 2Faculty of Health Sciences, Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.
• 3Centre for HIV and STIs, National Institute for Communicable Diseases, Johannesburg, South Africa.
• 4Centre for HIV and STIs, National Institute for Communicable Diseases, Johannesburg, South Africa Western Sydney Sexual Health Centre, Western Sydney Local Health District, Parramatta, Australia. 
• Sex Transm Infect. 2016 May 6. pii: sextrans-2015-052474. doi: 10.1136/sextrans-2015-052474.

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Efforts in Blood Safety: Integrated Approach for Serological Diagnosis of Syphilis

Recent efforts in transfusion medicine are focused on improving blood safety as well as establishing effective and efficient diagnostic algorithms for donor screening. To date, syphilis is a transfusion-transmitted infection re-emerged in many countries as a public health threat especially among populations at specific risk. 

This task requires new diagnostic tools and hemovigilance programs. The current diagnostic methodologies are debated, since presenting limitations and unresolved issues with special regard to the clinical interpretation of serological patterns, especially in asymptomatic patients and in blood donors. Furthermore, the switch from the traditional to alternative diagnostic algorithms underlines the lack of a gold standard, which has not been supported by shared guidelines. Besides, a lot of ongoing clinical trials on the performance of diagnostic assays, on the serological response associated with different pharmacological treatments, as well as on the prevention programs are currently under investigation. 

Here, we review the recent literature about the diagnosis of syphilis especially for low-risk populations proposing the adoption of an algorithm for blood donor screening that should satisfy the need of increasing safety for transfusion-transmitted infections in the modern blood transfusion centers.

Below:  The natural history of untreated syphilis in immunocompetent individuals

Below:  The actual testing algorithms for diagnosis of syphilis

Full article at:   http://goo.gl/X6O8mg

By:  Sommese L1, De Pascale MR1, Capuano M1, Napoli C1.

• 1Department of Transfusion Medicine and Transplant Immunology, U.O.C. Immunohematology, Regional Reference Laboratory of Transplant Immunology, Azienda Ospedaliera Universitaria, Second University of Naples, Italy. 
• Asian J Transfus Sci. 2016 Jan-Jun;10(1):22-30. doi: 10.4103/0973-6247.164267.

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Evaluation of SD BIOLINE Syphilis 3.0 for Rapid Diagnosis of Syphilis: Report from a Regional Sexually Transmitted Infection Reference Laboratory in North India

BACKGROUND:

Serology is considered the mainstay of syphilis diagnosis. The limitations of the traditional serological methods and the advent and availability of novel immunochromatographic assays have led to the widespread application of rapid point-of-care procedures as screening tools for syphilis. However, these tests have not been extensively evaluated. This study was designed to evaluate the performance of a rapid syphilis diagnostic test known as SD BIOLINE Syphilis 3.0 (SD Biostandard Diagnostics Private Limited, Gurgaon, Haryana, India).

MATERIALS AND METHODS:

A panel comprising of 50 venereal disease research laboratory reactive and 50 nonreactive sera was tested using SD BIOLINE Syphilis 3.0. The performance of the test was evaluated using IMMUTREP Treponema pallidum hemagglutination assay (TPHA) (OMEGA Diagnostics Limited, Scotland, United Kingdom) as the reference standard and sensitivity, specificity, and negative and positive predictive values were calculated.

RESULTS:

The sensitivity, specificity, and positive and negative predictive values of SD BIOLINE Syphilis 3.0 were 92.86% (confidence interval of 95%: 80.52-98.50%), 98.28% (90.76-99.96%), 97.50% (86.84-99.94%), and 95.00% (86.08-98.96%), respectively, compared to TPHA as the gold standard.

CONCLUSION:

Keeping in view the high sensitivity and specificity of SD BIOLINE Syphilis 3.0, we conclude that the test can be used as a tool for rapid on-site diagnosis of syphilis and as an alternative to TPHA for detection of antibodies to Treponema pallidum.

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By:  Mehra B1, Bhattar S1, Saxena S1, Rawat D1, Bhalla P1.

• 1Department of Microbiology, Maulana Azad Medical College, New Delhi, India. 
• J Lab Physicians. 2016 Jan-Jun;8(1):36-40. doi: 10.4103/0974-2727.176239.

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Sexually Transmitted Infection Testing among Adolescents and Young Adults in the United States

PURPOSE:

Persons aged 15-25 years have high sexually transmitted infection (STI) rates and suboptimal screening. There has been limited research analyzing barriers to STI testing at a national level. We examined STI testing among 15-25 year olds and reasons for not testing.

METHODS:

We used data from a national survey of youth. Bivariate and multivariable analyses examined differences in testing behaviors by demographics, separately by sex. Among sexually experienced respondents who reported never being tested, health system-related reasons for not testing were examined in bivariate and multivariable analyses.

RESULTS:

Females (16.6%) were more likely to have ever been tested compared with males (6.1%, p < .01) in the last 12 months. Among sexually experienced respondents who were never tested, 41.8% did not seek testing because they felt they were not at risk for STIs. Males (60.1%) had significantly higher reports of foregoing testing for confidentiality reasons compared with females (39.9%, p < .01). Non-Hispanic whites (44.9%) the highest reports of this compared with other ethnic/racial groups (p < .01).

CONCLUSIONS:

This national-level study found that most of the 15-25 year olds never received an STI test. In addition, confidentiality concerns may deter youth from seeking STI testing. Appropriate strategies to minimize these concerns may be useful. Potential strategies to ameliorate these issues may include engaging clinicians who frequently serve adolescents and young adults to address confidentiality issues with youth patients.

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By:  Cuffe KM1, Newton-Levinson A2, Gift TL2, McFarlane M2, Leichliter JS2.

• 1Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. Electronic address: kcuffe@cdc.gov.
• 2Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. 
• J Adolesc Health. 2016 Mar 14. pii: S1054-139X(16)00019-7. doi: 10.1016/j.jadohealth.2016.01.002. 

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Tools to Overcome Potential Barriers to Chlamydia Screening in General Practice: Qualitative Evaluation of the Implementation of a Complex Intervention

BACKGROUND:

Chlamydia trachomatis remains a significant public health problem. We used a complex intervention, with general practice staff, consisting of practice based workshops, posters, computer prompts and testing feedback and feedback to increase routine chlamydia screening tests in under 25 year olds in South West England. We aimed to evaluate how intervention components were received by staff and to understand what determined their implementation into ongoing practice.

METHODS:

We used face-to-face and telephone individual interviews with 29 general practice staff analysed thematically within a Normalisation Process Theory Framework which explores: 1. Coherence (if participants understand the purpose of the intervention); 2. Cognitive participation (engagement with and implementation of the intervention); 3. Collective action (work actually undertaken that drives the intervention forwards); 4. Reflexive monitoring (assessment of the impact of the intervention).

RESULTS:

Our results showed coherence as all staff including receptionists understood the purpose of the training was to make them aware of the value of chlamydia screening tests and how to increase this in their general practice. The training was described by nearly all staff as being of high quality and responsible for creating a shared understanding between staff of how to undertake routine chlamydia screening. Cognitive participation in many general practice staff teams was demonstrated through their engagement by meeting after the training to discuss implementation, which confirmed the role of each staff member and the use of materials. However several participants still felt unable to discuss chlamydia in many consultations or described sexual health as low priority among colleagues. National targets were considered so high for some general practice staff that they didn't engage with the screening intervention. Collective action work undertaken to drive the intervention included use of computer prompts which helped staff remember to make the offer, testing rate feedback and having a designated lead. Ensuring patients collected samples when still in the general practice was not attained in most general practices. Reflexive monitoring showed positive feedback from patients and other staff about the value of screening, and feedback about the general practices testing rates helped sustain activity.

CONCLUSIONS:

A complex intervention including interactive workshops, materials to help implementation and feedback can help chlamydia screening testing increase in general practices.

Full article at:   http://goo.gl/PwEzsq

By:  Ricketts EJ1, Francischetto EO2, Wallace LM3, Hogan A4, McNulty CA5.

• 1Public Health England Primary Care Unit, Microbiology Department, Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN, UK.
• 2NIHR CLAHRC West Midlands Chronic Disease Theme, Institute of Applied Health Research, University of Birmingham, Edgbaston B15 2TT, Birmingham, UK.
• 3Faculty of Health and Social Care, National Institutes of Health Research Health Services and Delivery Research Programme, The Open University, Walton Hall, Milton Keynes, MK7 6AA, UK.
• 4Health Protection Agency Primary Care Unit, Personalised Medicine Consortium Integrated Biobank of Luxembourg 6, Rue Nicolas Ernest Barblé, L-1210, Luxembourg.
• 5Public Health England Primary Care Unit, Microbiology Department, Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN, UK. cliodna.mcnulty@phe.gov.uk. 
• BMC Fam Pract. 2016 Mar 22;17(1):33. doi: 10.1186/s12875-016-0430-2.

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Syphilis among U.S.-Bound Refugees, 2009-2013

U.S. immigration regulations require clinical and serologic screening for syphilis for all U.S.-bound refugees 15 years of age and older. We reviewed syphilis screening results for all U.S.-bound refugees from January 1, 2009 through December 31, 2013. We calculated age-adjusted prevalence by region and nationality and assessed factors associated with syphilis seropositivity using multivariable log binomial regression models. 

Among 233,446 refugees, we identified 874 syphilis cases (373 cases per 100,000 refugees). The highest overall age-adjusted prevalence rates of syphilis seropositivity were observed among refugees from Africa (1340 cases per 100,000), followed by East Asia and the Pacific (397 cases per 100,000). In most regions, male sex, increasing age, and living in non-refugee camp settings were associated with syphilis seropositivity. 

Future analysis of test results, stage of infection, and treatment delivery overseas is warranted in order to determine the extent of transmission risk and benefits of the screening program.

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By:  Nyangoma EN1,2, Olson CK3, Painter JA3, Posey DL3, Stauffer WM3,4, Naughton M3, Zhou W3, Kamb M5, Benoit SR3.

• 1Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA, USA. ENyangoma@cdc.gov.
• 2Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS E-03, Atlanta, GA, USA. ENyangoma@cdc.gov.
• 3Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS E-03, Atlanta, GA, USA.
• 4Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
• 5Division of Sexually Transmitted Diseases Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
• J Immigr Minor Health. 2016 Mar 18.  

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Screening for Asymptomatic Gonorrhea and Chlamydia in the Pediatric Emergency Department

BACKGROUND:

Because adolescents rely heavily on emergency services for health care, a pediatric emergency department (PED) visit may be their only opportunity for sexually transmitted infection (STI) screening. The primary objectives of this study were to determine the proportion of Neisseria gonorrheae (GC) and Chlamydia trachomatis (CT) infections in asymptomatic PED adolescents and patient-perceived barriers to STI screening.

METHODS:

A convenience sample of patients aged 14 to 21 years presenting to an urban PED with nongenitourinary complaints was offered screening for GC and CT. Regardless of declining or accepting screening, all were asked to complete a questionnaire designed to identify barriers to screening.

RESULTS:

Sixty-eight percent of those approached participated (n = 719). Those who agreed to STI screening were more likely to be nonwhite (61.4% vs. 38.6%, P = 0.001) and publically insured (63.3%) versus privately insured (29.3%) or no insurance (7.58%). Four hundred three (56%) participants provided urine samples, and of those, 40 (9.9%) were positive for an STI. Controlling for other demographics, race was a significant predictor, with the odds of testing positive for nonwhite participants 5.90 times that of white participants. Patients who refused testing were more likely to report not engaging in sexual activity (54.3% vs. 42.4%, P = 0.009) and less likely to perceive that they were at risk for STIs.

CONCLUSIONS:

There are high proportions of GC and CT among asymptomatic adolescents visiting an academic urban PED. A universal PED STI screening program may be an important component of STI reduction initiatives, especially among adolescents who do not perceive that they are at risk and may not receive testing elsewhere.

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By:  Schneider K1, FitzGerald M, Byczkowski T, Reed J.

• 1From the*Division of Emergency Medicine, Cincinnati Children's Hospital, Cincinnati, OH; and †Division of Pediatric Emergency Medicine, University of Minnesota Children's Hospital, Minneapolis, MN. 
• Sex Transm Dis. 2016 Apr;43(4):209-15. doi: 10.1097/OLQ.0000000000000424.

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Regular STI Testing amongst Men Who Have Sex with Men & Use Social Media Is Suboptimal - A Cross-Sectional Study

Sexually transmitted infections (STIs) disproportionately affect men who have sex with men, with marked increases in most STIs in recent years. These are likely underpinned by coterminous increases in behavioural risks which have coincided with the development of Internet and geospatial sociosexual networking. 

Current guidelines advocate regular, annual sexually transmitted infection testing amongst sexually active men who have sex with men (MSM), as opposed to symptom-driven testing. This paper explores sexually transmitted infection testing regularity amongst MSM who use social and sociosexual media. 

Data were collected from 2668 men in Scotland, Wales, Northern Ireland and the Republic of Ireland, recruited via social and gay sociosexual media. Only one-third of participants report regular (yearly or more frequent) STI testing, despite relatively high levels of male sex partners, condomless anal intercourse and high-risk unprotected anal intercourse. The following variables were associated with regular STI testing; being more 'out' (adjusted odds ratio = 1.79; confidence interval = 1.20-2.68), HIV-positive (adjusted odds ratio = 14.11; confidence interval = 7.03-28.32); reporting ≥10 male sex partners (adjusted odds ratio = 2.15; confidence interval = 1.47-3.14) or regular HIV testing (adjusted odds ratio = 48.44; confidence interval = 28.27-83.01). Men reporting long-term sickness absence from work/carers (adjusted odds ratio = 0.03; confidence interval = 0.00-0.48) and men aged ≤25 years (adjusted odds ratio = 0.36; 95% confidence interval = 0.19--0.69) were less likely to test regularly for STIs. 

As such, we identify a complex interplay of social, health and behavioural factors that each contribute to men's STI testing behaviours. In concert, these data suggest that the syndemics placing men at elevated risk may also mitigate against access to testing and prevention services. Moreover, successful reduction of STI transmission amongst MSM will necessitate a comprehensive range of approaches which address these multiple interrelated factors that underpin MSM's STI testing.

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By:  Frankis J1, Goodall L2, Clutterbuck D3, Abubakari R4, Flowers P5.

• 1School of Health and Life Sciences, Glasgow Caledonian University, Glasgow j.frankis@gcu.ac.uk.
• 2Cobridge Sexual Health Centre, Church Terrace, Cobridge, Stoke on Trent.
• 3Chalmers Sexual Health Centre, NHS Lothian, Edinburgh.
• 4School of Health and Life Sciences, GCU London, Glasgow Caledonian University, Glasgow.
• 5School of Health and Life Sciences, Glasgow Caledonian University, Glasgow. 
• Int J STD AIDS. 2016 Mar 4. pii: 0956462416636780.

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Rapid Syphilis Testing Is Cost-Effective Even in Low-Prevalence Settings: The CISNE-PERU Experience

Studies have addressed cost-effectiveness of syphilis testing of pregnant women in high-prevalence settings. This study compares costs of rapid syphilis testing (RST) with laboratory-based rapid plasma reagin (RPR) tests in low-prevalence settings in Peru. The RST was introduced in a tertiary-level maternity hospital and in the Ventanilla Network of primary health centers, where syphilis prevalence is approximately 1%. The costs per woman tested and treated with RST at the hospital were $2.70 and $369 respectively compared with $3.60 and $740 for RPR. For the Ventanilla Network the costs per woman tested and treated with RST were $3.19 and $295 respectively compared with $5.55 and $1454 for RPR. The cost per DALY averted using RST was $46 vs. $109 for RPR. RST showed lower costs compared to the WHO standard costs per DALY ($64). Findings suggest syphilis screening with RST is cost-effective in low-prevalence settings.

Below:  RST and RPR cost components

Below:  Costs per woman screened and treated, by service comparing RST vs RPR at INMP and Ventanilla Network

Full article at:   http://goo.gl/mVWfxq

By:  Mallma P1, Garcia P1, Carcamo C1, Torres-Rueda S2, Peeling R2, Mabey D2, Terris-Prestholt F2.

• 1Epidemiology, STD/HIV Unit, School of Public Health, Universidad Peruana Cayetano Heredia, Lima, Peru.
• 2London School of Hygiene and Tropical Medicine, London, United Kingdom. 
• PLoS One. 2016 Mar 7;11(3):e0149568. doi: 10.1371/journal.pone.0149568. eCollection 2016.

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Correlates of HIV and STI Testing among Latino Men Who Have Sex with Men in New York City

We assessed the extent to which sociodemographic, personal, and behavioral factors are associated with human immunodeficiency virus/sexually transmitted infection (HIV/STI) testing among a diverse group of Latino men who have sex with men (MSM) in New York City. 

The triangulation approach was used to synthesize data from 176 MSM who completed an in-person or phone questionnaire about substance use, alcohol consumption, sexual behaviors, and HIV/STI testing history and 40 participants who participated in focus groups. Correlates of testing significant in univariable analyses (p < .05) were entered into multivariable logistic regression models. 

Over half (57.9%) of study subjects tested for HIV in the previous 12 months and 60.2% tested for STIs in the previous 12 months. Age and education were positively correlated with HIV testing in multivariable analysis. No significant correlates of STI testing were identified. Spanish-speaking only subjects were less likely to get tested for HIV and STI; however, this association was not significant. 

Our study demonstrates the need for further study of predictors of STI testing as well as the potential role of language barriers and education in routine testing for HIV. Social and behavioral factors may intensify these obstacles. 

Future research and interventions should address the role of language barriers and perceived issues of immigration status in the decision to get tested.

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By:  Joseph T. Spadafino^a*, Omar Martinez^b, Ethan C. Levine^c, Brian Dodge^d, Miguel Muñoz-Laboy^b & M. Isabel Fernandez^e

• ^a Arizona Department of Health Services, Phoenix, AZ, USA
• ^b College of Public Health, Temple University, Philadelphia, PA, USA
• ^c College of Liberal Arts, Temple University, Philadelphia, PA, USA
• ^d School of Public Health, Indiana University-Bloomington, Bloomington, IN, USA
• ^e Department of Public Health, Nova Southeastern University, Fort Lauderdale, FL, USA

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Survey of Partner Notification Practices for Sexually Transmissible Infections in the United States

Background:

Partner notification (PN) for sexually transmissible infections (STIs) is a vital STI control method. The most recent evaluation of PN practices in the United States, conducted in 1999, indicated that few STI patients were offered PN services. The objectives of this study were to obtain a preliminary understanding of the current provision of PN services in HIV/STI testing sites throughout the US and to determine the types of PN services available.

Methods:

A convenience sample of 300 randomly selected testing sites was contacted to administer a phone survey about PN practices. These sites were from a large database maintained by the Centers for Disease Control and Prevention. Sites were eligible to participate if they provided testing services for chlamydia, gonorrhoea, HIV or syphilis and were not hospitals or Planned Parenthood locations.

Results:

Of the 300 eligible sites called, 79 sites were successfully reached, of which 74 agreed to participate, yielding a response rate of 24.7% and a cooperation rate of 93.7%. Most surveyed testing sites provided some form of PN service (anonymous or non-anonymous) on site or through an affiliate for chlamydia (100%), gonorrhoea (97%), HIV (91%) and syphilis (96%) infection. Anonymous PN services were available at 67-69% of sites. Only 6-9% of sites offered Internet-based PN services.

Conclusions:

Most surveyed testing sites currently offer some type of PN service for chlamydia, gonorrhoea, HIV or syphilis infection. However, approximately one-third of surveyed sites do not offer anonymous services. Novel, Internet-based methods may be warranted to increase the availability of anonymous services.

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By:  Fidel A. Desir ^A B D, Jessica H. Ladd ^A and Charlotte A. Gaydos ^C 

^A Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA. 
^B Johns Hopkins University School of Medicine, 855 North Wolfe Street, 530 Rangos Building, Baltimore, MD 21215, USA. 
^C Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 East Monument Street, Baltimore, MD 21205, USA. 
^D Corresponding author. Email: fdesir@jhmi.edu 

Sex Health. 2016 Feb 4. doi: 10.1071/SH15136. 

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