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.

Purchase full article at:  http://goo.gl/hO5aVk

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.

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health

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.

Purchase full article at:   http://goo.gl/Jveh26

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.

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health

The Prevalence of Syphilis from the Early HIV Period Is Correlated with Peak HIV Prevalence at a Country Level

BACKGROUND:

Could we have predicted national peak HIV based on syphilis prevalence in the 1990s? Earlier studies have shown positive correlations between various sexually transmitted infections at different population levels. In this article, we test the hypothesis that there was a residual variation in the national prevalence rates of syphilis and that these rates could predict subsequent peak HIV prevalence rates.

METHODS:

This analysis uses linear regression to evaluate the country-level relationship between antenatal syphilis prevalence (1990-1999) and peak HIV prevalence. Antenatal syphilis data were taken from an Institute for Health Metrics and Evaluation database on the prevalence of syphilis in low-risk populations. Peak HIV prevalence was calculated based on data taken from the Global Health Observatory Data Repository of the World Health Organization.

RESULTS:

A moderately strong association is found for the 76 countries with data available (R = 0.53, P < 0.001). The association was weakened but remained significantly positive when we adjusted for the type of syphilis testing used.

CONCLUSIONS:

Syphilis prevalence in the 1990s predicted approximately 53% of the variation in peak HIV prevalence. Populations with generalized HIV epidemics had a higher prevalence of syphilis in the pre-HIV period. This finding provides additional rationale to carefully monitor sexual behavior, sexual networks, and sexually transmitted infection incidence in these populations.

Purchase full article at:   http://goo.gl/yNWzvw

By:  Osbak KK1, Rowley JT, Kassebaum NJ, Kenyon CR.

• 1From the *HIV/STI Unit, Institute of Tropical Medicine, Antwerp, Belgium; †London, United Kingdom; ‡Institute for Health Metrics and Evaluation, Seattle Children's Hospital, University of Washington, Seattle, WA; and §Division of Infectious Diseases and HIV Medicine, University of Cape Town, Cape Town, South Africa. 
• Sex Transm Dis. 2016 Apr;43(4):255-7. doi: 10.1097/OLQ.0000000000000422.

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health

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.

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health

Implementation of Fast Tests for Syphilis and HIV in Prenatal Care in Fortaleza - Ceará

OBJECTIVE:

to describe the implementation of the Fast Test (FT) of syphilis and HIV in prenatal care in primary healthcare units in Fortaleza, Ceará.

METHOD:

a descriptive study with a quantitative approach. There were training supervisions carried out in 24 units between May and August 2014, and the inclusion criterion was to have at least one trained professional.

RESULTS:

the physical space, the availability, validity and the performance of FT in prenatal were analyzed. The data were presented in simple frequency tables. It was identified adequate space in 79.2% of the units, availability of FT in 62.5%, performing the tests in 37.5%, and of these, 55.6% doing these procedures in routine prenatal care.

CONCLUSION:

the primary units have difficulties in implementing FT in syphilis and HIV in the prenatal routine. This activity is seen as an effective strategy to reduce vertical transmission of these infections.

Aspects related to physical space to perform the Fast Test in primary health care units, Fortaleza, Ceará, Brazil, 2014 

Variables	n	%
Complete ESF (n=24)
Yes	11	44.8
No	13	55.2
Trained professionals (n = 24)
Nurses	20	83.3
Doctors	04	16.7
Private offices (n=24)
Yes	19	79.2
No	05	20.8
Refrigerator exclusive for FT (n = 24)
Yes	18	75.0
No	06	25.0

Aspects related to implementation of the Fast Test (TR) in Primary Health Care Units (UAPS), Fortaleza, Ceará, Brazil, 2014 

Variables	n	%
Had FT in the unit (n=24)
Yes	15	62.5
No	09	37.5
FT in the valdity date (n = 15)
Yes	05	33.4
No	10	66.6
Perform Ft in the unit (n=24)
Yes	09	37.5
No	15	62.5
Perform FT in the routine of PN care (n = 09)
Yes	05	55.6
No	04	44.4

Purchase full article [in English, Portuguese] at:   http://goo.gl/233nMG

By:  Lopes AC1, Araújo MA1, Vasconcelo LD2, Uchoa FS3, Rocha HP4, Santos JR5.

• 1Programa de Pós-Graduação em Saúde Coletiva, Universidade de Fortaleza, Fortaleza, CE, Brasil.
• 2Área Técnica de Saúde da Mulher e Gênero, Rede Cegonha, Secretaria Municipal de Saúde, Fortaleza, CE, Brasil.
• 3Área Técnica de DST/Aids e Hepatites Virais, Secretaria Municipal de Saúde, Fortaleza, CE, Brasil.
• 4Hospital Universitário Walter Cantídio, Universidade Federal do Ceará, Fortaleza, CE, Brasil.
• 5Residência Integrada em Saúde, Escola de Saúde Pública do Ceará, Fortaleza, CE, Brasil.
• Rev Bras Enferm. 2016 Feb;69(1):62-66. 

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health

Hepatitis C Screening in People with Human Immunodeficiency Virus: Lessons Learned from Syphilis Screening

Background.  

The incidence of hepatitis C virus (HCV) infection is increasing in human immunodeficiency virus (HIV)-positive men who have sex with men (MSM). New guidelines recommend annual screening for HCV, similar to recommendations for syphilis screening with rapid plasma reagin (RPR). 

Methods. 

This study compares the frequency of repeat HCV antibody (Ab) testing to repeat RPR testing in a retrospective chart review of 359 HCVAb-negative people living with HIV (PLWH) observed in an Infectious Diseases clinic. Patients were classified into risk groups based on sexual risk factors. 

Results.

Although 85% of PLWH had repeat syphilis screening, less than two thirds had repeat HCVAb screening. The MSM status was associated with increased HCVAb and RPR testing (adjusted odds ratio, 2.6 and 5.9, respectively). Seven persons had incident HCV infection: 3 were MSM, and 4 had symptoms or abnormal laboratory results to prompt testing. 

Conclusions.

Failure to find incident HCV infection in PLWH represents missed opportunities to cure HCV infection and prevent progressive liver disease. Further quality improvement studies are necessary to develop physician-focused interventions to increase HCV screening rates in PLWH.

Full article at:   https://goo.gl/hCydqw

By:  Wurcel AG1, Chen DD2, Fitzpatrick RE2, Grasberger PE2, Kirshner CH2, Anderson JE2, Chui KK2, Knox TA2.

• 1Department of Geographic Medicine and Infectious Diseases, Tufts Medical Center; Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.
• 2Department of Public Health and Community Medicine , Tufts University School of Medicine , Boston, Massachusetts. 
• Open Forum Infect Dis. 2016 Feb 12;3(1):ofv215. doi: 10.1093/ofid/ofv215. eCollection 2016.

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health

Was Infectious Syphilis Being Misclassified in Remote Australian Outbreaks? Evidence that Informed Modification of the National Case Definition

OBJECTIVE:

To assess the ability of the national case definition to identify infectious syphilis during an outbreak affecting predominantly Aboriginal and Torres Strait Islander people in a remote Australian region.

METHODS:

A retrospective case series study of all non-congenital syphilis cases in the region notified between 1 January 2009 and 31 December 2012 was performed. The national infectious syphilis case definition was compared with an expanded case definition derived from experienced clinician assessment and the definition proposed in the Interim Guidelines for the Public Health Management of Syphilis Outbreaks in Remote Populations in Australia from the Communicable Diseases Network Australia (CDNA).

RESULTS:

Two hundred and forty syphilis cases were notified, of which 44 (18.3%) were symptomatic. The national case definition classified 106 (44.2%) cases as infectious, compared with 182 (75.8%) using the clinician-derived expanded case definition and 165 (68.8%) by the interim guidelines case definition. Seven confirmed and 6 probable cases were diagnosed as a result of contact tracing of probable infectious cases identified using the expanded case definition.

CONCLUSIONS AND IMPLICATIONS:

The national case definition for infectious syphilis applied in this remote Australian outbreak underestimated infectious cases when compared with experienced clinicians' evaluation by up to 76 cases (42%) and was inadequate to monitor the magnitude of a syphilis outbreak in such a setting. This may compromise surveillance and resource allocation decisions, and could reduce the capacity to interrupt transmission and contain an outbreak. A revised national case definition, informed by this analysis, was released by CDNA in July 2015.

Below:  Epidemic curve of infectious syphilis in a north Queensland district, 2009 to 2012, by national definition, expanded case definition and Interim Guidelines case definition

Full article at:  http://goo.gl/HtXz46

By:  Preston-Thomas A1, Ryder N2, Harmen S3, Fagan P4.

• 1Public Health Physician (Sexual Health), Tropical Public Health Services, Cairns, Queensland.
• 2Clinical Director Sexual Health, John Hunter Hospital, Hunter New England Local Health District, New South Wales.
• 3Manager Health Surveillance, Tropical Public Health Services, Cairns, Queensland.
• 4Adjunct Associate Professor, James Cook University, Cairns, Queensland. 

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health

Enhanced Syphilis Screening among HIV-Positive Men (ESSAHM): A Study Protocol for a Clinic-Randomized Trial with Stepped Wedge Design

BACKGROUND:

The current syphilis epidemic among urban men who have sex with men (MSM) has serious implications for those co-infected with human immunodeficiency virus (HIV). Routine and frequent syphilis screening has the potential to ensure early detection and treatment, minimize disease burden, and help control the ongoing spread of syphilis and HIV. We aim to enhance syphilis screening among HIV-positive men by conducting a clinic-based intervention that incorporates opt-out syphilis testing into routine HIV laboratory evaluation for this population. Trial objectives are to determine the degree to which the intervention (1) increases the detection rate of untreated syphilis, (2) increases screening coverage, (3) increases screening frequency, and (4) reaches men at highest risk according to sexual behaviors.

METHODS/DESIGN:

The trial is a pragmatic, stepped wedge cluster-randomized controlled trial that introduces the intervention stepwise across four urban HIV clinics in Ontario, Canada. The intervention includes standing orders for syphilis serological testing whenever a male in HIV care undergoes HIV viral load testing, which typically occurs every 3-6 months. The control condition is the maintenance of current, provider-initiated syphilis testing practice. Approximately 3100 HIV-positive men will be followed over 30 months. Test results will be obtained from the centralized provincial laboratory in Ontario and will be supplemented by a standardized clinical worksheet and medical chart review at the clinics. Detailed clinical, psychosocial, and behavioral data is available for a subset of men receiving HIV care who are also participants of the province-wide Ontario HIV Treatment Network Cohort Study. Process evaluation plans include audit and feedback of compliance of the participating centers to identify potential barriers to the introduction of this type of practice into routine care. Health economic components include evaluation of the impact and cost-effectiveness of the intervention.

DISCUSSION:

This trial will be the first of its kind in Canada and will provide evidence regarding the feasibility, clinical effectiveness, and cost-effectiveness of a clinic-based intervention to improve syphilis screening among HIV-positive men. Involvement of knowledge users in all stages of trial design, conduct, and analysis will facilitate scale-up should the intervention be effective.

Below:  Stepped wedge design for the Enhanced Syphilis Screening among HIV-positive Men (ESSAHM) Trial

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

By:  Burchell AN1,2,3, Allen VG4, Grewal R5, MacPherson PA6,7,8, Rachlis A9,10, Walmsley S11,12, Mishra S13,14, Gardner SL15,16, Raboud J17,18, Cooper C19,Gough K20,21, Rourke SB22,23,24, Rousseau R25,26, Salit I27,28, Tan DH29,30,31,32.

• 1Department of Family and Community Medicine, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada. burchella@smh.ca.
• 2Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. burchella@smh.ca.
• 3Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. burchella@smh.ca.
• 4Public Health Ontario Laboratories, Public Health Ontario, Toronto, Canada. vanessa.allen@oahpp.ca.
• 5Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. grewalra@smh.ca.
• 6Division of Infectious Diseases, The Ottawa Hospital, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.
• 7Ottawa Hospital Research Institute, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.
• 8Department of Medicine, University of Ottawa, Ottawa, Canada. pmacpherson@ottawahospital.on.ca.
• 9Sunnybrook Health Sciences Centre, Toronto, Canada. anita.rachlis@sunnybrook.ca.
• 10Department of Medicine, University of Toronto, Toronto, Canada. anita.rachlis@sunnybrook.ca.
• 11Department of Medicine, University of Toronto, Toronto, Canada. sharon.walmsley@uhn.ca.
• 12Toronto General Hospital, University Health Network, Toronto, Canada. sharon.walmsley@uhn.ca.
• 13Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada. sharmistha.mishra@utoronto.ca.
• 14Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Canada. sharmistha.mishra@utoronto.ca.
• 15Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. sgardner@ohtn.on.ca.
• 16Ontario HIV Treatment Network, Toronto, Canada. sgardner@ohtn.on.ca.
• 17Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. jraboud@uhnresearch.ca.
• 18Toronto General Research Institute, University Health Network, Toronto, Canada. jraboud@uhnresearch.ca.
• 19Ottawa Hospital Research Institute, Ottawa, Canada. ccooper@ottawahospital.on.ca.
• 20Department of Medicine, University of Toronto, Toronto, Canada. goughk@smh.ca.
• 21Division of Infectious Diseases, St. Michael's Hospital, Toronto, Canada. goughk@smh.ca.
• 22Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. sean.rourke@utoronto.ca.
• 23Ontario HIV Treatment Network, Toronto, Canada. sean.rourke@utoronto.ca.
• 24Department of Psychiatry, University of Toronto, Toronto, Canada. sean.rourke@utoronto.ca.
• 25Department of Immunology, University of Toronto, Toronto, Canada. r.rousseau@mail.utoronto.ca.
• 26Poz Prevention Working Group, Gay Men's Sexual Health Alliance, Toronto, Canada. r.rousseau@mail.utoronto.ca.
• 27Department of Medicine, University of Toronto, Toronto, Canada. irving.salit@uhn.on.ca.
• 28Toronto General Hospital, University Health Network, Toronto, Canada. irving.salit@uhn.on.ca.
• 29Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. darrell.tan@gmail.com.
• 30Department of Medicine, University of Toronto, Toronto, Canada. darrell.tan@gmail.com.
• 31Toronto General Research Institute, University Health Network, Toronto, Canada. darrell.tan@gmail.com.
• 32Division of Infectious Diseases, St. Michael's Hospital, Toronto, Canada. darrell.tan@gmail.com. 
• Implement Sci. 2016 Jan 16;11(1):8. doi: 10.1186/s13012-016-0371-0.

More at:  https://twitter.com/hiv insight

And: http://twitter.com/Prison Health