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      Screening for HIV, hepatitis B and syphilis on dried blood spots: A promising method to better reach hidden high-risk populations with self-collected sampling

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          Abstract

          Introduction

          Many people at high risk for sexually transmitted infections (STIs), e.g., men who have sex with men (MSM), are not optimally reached by current sexual health care systems with testing. To facilitate testing by home-based sampling or sampling in outreach setting we evaluated dried blood spots (DBS), a method for self-collected blood sampling for serological screening of HIV, hepatitis B (HBV) and syphilis. The aims of this study were to assess the acceptability and feasibility of self-collected DBS and to compare the test results for screening of HIV, HBV and syphilis from DBS with blood drawn by venous puncture.

          Methods

          DBS were collected from men who have sex with men (MSM), visiting the STI clinic of the public health service South Limburg (n = 183) and HIV positive and HBV positive patients (n = 34), visiting the outpatient clinics of the Maastricht University Medical Centre in the period January 2012–April 2015. The 93 first participating MSM visiting the STI clinic were asked to fill in a questionnaire about the feasibility and acceptability about self-collection of DBS in a setting without going to a health care facility and were asked to collect the DBS themselves. Serological screening tests for HIV (HIV combi PT, Roche), HBV (HBsAg, Roche) and syphilis ( Treponema pallidum Ig, Biokit 3.0) were performed on DBS and on blood drawn by venous puncture, which was routinely taken for screening.

          Results

          In total 217 participants were included in the study with a median age of 40 years (range between 17–80). Of MSM 84% agreed that it was clear and easy to do the finger-prick, while 53% agreed that it was clear and easy to apply the blood onto the DBS card. Also, 80% of MSM would use the bloodspot test again. In 91% (198) of DBS, sufficient material was collected to perform the three tests. No difference was observed in DBS quality between self-collected DBS and health care worker collected DBS. For HIV (n = 195 DBS-serum pairs) sensitivity and specificity were 100%. For HBV the sensitivity for HBsAg (n = 202) was 90% and specificity was 99%. For syphilis (n = 191) the sensitivity of the DBS was 93% with a specificity of 99%. Analysis of the DBS of HIV positive participants (n = 38) did show similar test performance for HBV and syphilis as in HIV negatives.

          Conclusion

          DBS is an acceptable self-sampling method for MSM, as there was no difference in DBS quality in self-collected and health care worker collected DBS. Test performance, i.e., its high sensitivity (>90%) and specificity (>99%) measures show that DBS is a valid alternative for venous blood puncture. Especially when DBS is combined with home-collected sampling for Chlamydia trachomatis and Neisseria gonorrhoeae, complete STI screening can be done in outreach setting and/or home-collected sampling in MSM.

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          Most cited references29

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          Serum hepatitis B surface antigen and hepatitis B e antigen titers: disease phase influences correlation with viral load and intrahepatic hepatitis B virus markers.

          Although threshold levels for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) titers have recently been proposed to guide therapy for chronic hepatitis B (CHB), their relationship to circulating hepatitis B virus (HBV) DNA and intrahepatic HBV replicative intermediates, and the significance of emerging viral variants, remains unclear. We therefore tested the hypothesis that HBsAg and HBeAg titers may vary independently of viral replication in vivo. In all, 149 treatment-naïve CHB patients were recruited (HBeAg-positive, n = 71; HBeAg-negative, n = 78). Quantification of HBeAg and HBsAg was performed by enzyme immunoassay. Virological characterization included serum HBV DNA load, HBV genotype, basal core promoter (BCP)/precore (PC) sequence, and, in a subset (n = 44), measurement of intrahepatic covalently closed circular DNA (cccDNA) and total HBV DNA, as well as quantitative immunohistochemical (IHC) staining for HBsAg. In HBeAg-positive CHB, HBsAg was positively correlated with serum HBV DNA and intrahepatic cccDNA and total HBV DNA (r = 0.69, 0.71, 0.76, P < 0.01). HBeAg correlated with serum HBV DNA (r = 0.60, P < 0.0001), although emerging BCP/PC variants reduced HBeAg titer independent of viral replication. In HBeAg-negative CHB, HBsAg correlated poorly with serum HBV DNA (r = 0.28, P = 0.01) and did not correlate with intrahepatic cccDNA nor total HBV DNA. Quantitative IHC for hepatocyte HBsAg confirmed a relationship with viral replication only in HBeAg-positive patients. The correlation between quantitative HBsAg titer and serum and intrahepatic markers of HBV replication differs between patients with HBeAg-positive and HBeAg-negative CHB. HBeAg titers may fall independent of viral replication as HBeAg-defective variants emerge prior to HBeAg seroconversion. These findings provide new insights into viral pathogenesis and have practical implications for the use of quantitative serology as a clinical biomarker.
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            Effectiveness of yearly, register based screening for chlamydia in the Netherlands: controlled trial with randomised stepped wedge implementation

            Objective To evaluate the effectiveness of register based, yearly chlamydia screening. Design Controlled trial with randomised stepped wedge implementation in three blocks. Setting Three regions of the Netherlands: Amsterdam, Rotterdam, and South Limburg. Participants 317 304 women and men aged 16-29 years listed on municipal registers at start of trial. Intervention From March 2008 to February 2011, the Chlamydia Screening Implementation programme offered yearly chlamydia screening tests. Postal invitations asked people to use an internet site to request a kit for self collection of samples, which would then be sent to regional laboratories for testing. Treatment and partner notification were done by the general practitioner or at a sexually transmitted infection clinic. Main outcome measures Primary outcomes were the percentage of chlamydia tests positive (positivity), percentage of invitees returning a specimen (uptake), and estimated chlamydia prevalence. Secondary outcomes were positivity according to sex, age, region, and sociodemographic factors; adherence to screening invitations; and incidence of self reported pelvic inflammatory disease. Results The participation rate was 16.1% (43 358/269 273) after the first invitation, 10.8% after the second, and 9.5% after the third, compared with 13.0% (6223/48 031) in the control block invited at the end of round two of the intervention. Chlamydia positivity in the intervention blocks at the first invitation was the same as in the control block (4.3%) and 0.2% lower at the third invitation (odds ratio 0.96 (95% confidence interval 0.83 to 1.10)). No substantial decreases in positivity were seen after three screening rounds in any region or sociodemographic group. Among the people who participated three times (2.8% of all invitees), positivity fell from 5.9% to 2.9% (odds ratio 0.49 (0.47 to 0.50)). Conclusions There was no statistical evidence of an impact on chlamydia positivity rates or estimated population prevalence from the Chlamydia Screening Implementation programme after three years at the participation levels obtained. The current evidence does not support a national roll out of this register based chlamydia screening programme. Trial registration NTR 3071 (Netherlands Trial Register, www.trialregister.nl).
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              High performance and acceptability of self-collected rectal swabs for diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in men who have sex with men and women.

              Identification of sexually transmitted infections (STI) is limited by the infrequent assessment of rectal STI. This study assesses usability of self-collected rectal swabs (SRS) in diagnosing rectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). In 2006 to 2007, clients of the Amsterdam and South Limburg STI outpatient clinics reporting receptive anal intercourse were asked to fill out a questionnaire and provide SRS. A standard provider-collected rectal swab (PRS) was also taken, and both were tested for CT and NG by a nucleic acid amplification tests. SRS performance was compared with PRS as to agreement, sensitivity, and specificity. Prevalence of rectal CT was 11% among the 1458 MSM and 9% among the 936 women. Rectal NG prevalence was 7% and 2%. In 98% of both MSM and women, SRS and PRS yielded concordant CT test results, for NG agreement was 98% for MSM and 99.4% for women. SRS performance for CT and NG diagnosis was good in both groups and was comparable for both study regions. Slightly more (57% of MSM, 62% of women) preferred SRS to PRS or had no preference; 97% would visit the STI clinic again if SRS was standard practice. Because anal sex is a common practice for MSM and women, and anal STI are frequently present, rectal screening should be an essential part of an STI consultation. SRS is a feasible, valid, and acceptable alternative for MSM and women attending STI clinics, and hence should be considered for other settings as well.
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                Author and article information

                Contributors
                Role: Formal analysisRole: InvestigationRole: MethodologyRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: MethodologyRole: Writing – review & editing
                Role: Formal analysisRole: InvestigationRole: Validation
                Role: Resources
                Role: ConceptualizationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                20 October 2017
                2017
                : 12
                : 10
                : e0186722
                Affiliations
                [1 ] Department of Medical Microbiology, Maastricht University Medical Centre, Maastricht, The Netherlands
                [2 ] Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
                [3 ] Department for Sexual Health, Infectious Diseases and Environmental Health, Public Health Service South Limburg, Geleen, The Netherlands
                [4 ] Centre Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
                [5 ] Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands
                [6 ] Institute of Tropical Medicine, Antwerp, Belgium
                Centers for Disease Control and Prevention, UNITED STATES
                Author notes

                Competing Interests: None of the authors have competing interests.

                Author information
                http://orcid.org/0000-0002-5960-4357
                Article
                PONE-D-17-24201
                10.1371/journal.pone.0186722
                5650165
                29053737
                ba16eb43-9feb-41a4-8be7-e6d1618b6366
                © 2017 van Loo et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 26 June 2017
                : 8 October 2017
                Page count
                Figures: 1, Tables: 4, Pages: 11
                Funding
                Funded by: National Institute for Public Health and the Environment
                Award Recipient :
                This study was funded by the National Institute for Public Health and the Environment to Christian J.P.A. Hoebe. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
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