Evaluation of INNO-LIA Syphilis Assay as a Confirmatory Test for Syphilis

We evaluated the sensitivity and specificity of a new confirmatory test for treponemal antibodies, INNO-LIA Syphilis (Innogenetics NV, Ghent, Belgium), on a large number of sera from a clinical laboratory. This multiparameter line immunoassay (LIA) uses recombinant and synthetic polypeptide antigens derived from Treponema pallidum proteins. In a single-blinded cross-sectional retrospective study, 289 seronegative sera, 219 seropositive sera, and 23 sera with an indeterminate serological status for syphilis were analyzed. All sera were tested by the T. pallidum hemagglutination assay (TPHA), the immunoglobulin (IgG)-fluorescent T. pallidum absorption assay (IgG-FTA-ABS), and the Venereal Disease Research Laboratory (VDRL) test. In addition, some seropositive samples were analyzed by the 19S-IgM-FTA-ABS test, an enzyme immunoassay (IgM-EIA), and the MarDx immunoblotting assay. Based on a consensus diagnosis derived from conventional serology, all of the sera were classified as positive, negative, or indeterminate, and the results were compared with the findings of the INNO-LIA Syphilis assay. The sensitivity and specificity of the LIA were 100% (219 of 219) and 99.3% (286 of 288), respectively. Compared to TPHA and IgG-FTA-ABS, the new test gave a significantly higher number (P = 0.021 and P < 0.0001, respectively) of correct results than either of the other two tests. The multiparameter INNO-LIA Syphilis assay is a useful confirmatory test for syphilis because it increases the reliability of syphilis diagnosis with respect to current conventional techniques

Time trends of syphilis and HSV-2 co-infection among men who have sex with men in the German HIV-1 seroconverter cohort from 1996–2007

Objectives: Numbers of newly diagnosed HIV infections among men who have sex with men (MSM) in Germany increased after the year 2000. We sought to explore trends in STI co-infections around the time of HIV seroconversion in patients from the German HIV-1 seroconverter cohort from 1996–2007. Methods: MSM from the cohort were included for secondary analysis, if seroconversion occurred between 1996 and 2007 and if a blood sample taken within 2 y after HIV infection was available for further testing. Samples were tested for antibodies against Treponema pallidum and HSV-2. A classification system was developed to assign the chronology of syphilis and HIV-1 infection. Results: Data of 1052 MSM were eligible for analysis. Overall seroprevalence of syphilis markers was 26%, increasing from 10% (1996–1999) to 35% (2005). Among HIV seroconverters with positive syphilis antibodies, 32% (n=88) were rated as having had coincident infections with HIV and syphilis. Coincident syphilis infection at HIV diagnosis increased substantially (

Is Serological Testing a Reliable Tool in Laboratory Diagnosis of Syphilis? Meta-Analysis of Eight External Quality Control Surveys Performed by the German Infection Serology Proficiency Testing Program

The accuracy of diagnostic tests is critical for successful control of epidemic outbreaks of syphilis. The reliability of syphilis serology in the nonspecialist laboratory has always been questioned, but actual data dealing with this issue are sparse. Here, the results of eight proficiency testing sentinel surveys for diagnostic laboratories in Germany between 2000 and 2003 were analyzed. Screening tests such as Treponema pallidum hemagglutination assay (mean accuracy, 91.4% [qualitative], 75.4% [quantitative]), Treponema pallidum particle agglutination assay (mean accuracy, 98.1% [qualitative], 82.9% [quantitative]), and enzyme-linked immunosorbent assays (ELISAs) (mean qualitative accuracy, 95%) were more reliable than Venereal Disease Research Laboratory (VDRL) testing (mean accuracy, 89.6% [qualitative], 71.1% [quantitative]), the fluorescent treponemal antibody absorption test (FTA-ABS) (mean accuracy, 88% [qualitative], 65.8% [quantitative]), and immunoblot assays (mean qualitative accuracy, 87.3%). Clearly, immunoglobulin M (IgM) tests were more difficult to manage than IgG tests. False-negative results for samples that have been unambiguously determined to be IgM and anti-lipoid antibody positive accounted for 4.7% of results in the IgM ELISA, 6.9% in the VDRL test, 18.5% in the IgM FTA-ABS, and 23.0% in the IgM immunoblot assay. For negative samples, the mean percentage of false-positive results was 4.1% in the VDRL test, 5.4% in the IgM ELISA, 0.7% in the IgM FTA-ABS, and 1.4% in the IgM immunoblot assay. On average, 18.3% of participants misclassified samples from patients with active syphilis as past infection without indicating the need for further treatment. Moreover, 10.2% of laboratories wrongly reported serological evidence for active infection in samples from patients with past syphilis or in sera from seronegative blood donors. Consequently, the continuous participation of laboratories in proficiency testing and further standardization of tests is strongly recommended to achieve better quality of syphilis serology

Schnelltest-Diagnostik sexuell übertragbarer Infektionen in niedrigschwelligen Einrichtungen

Am 5.2.16 fand am Robert-Koch-Institut in Berlin ein Expertentreffen zum Thema „Schnelltests in der Diagnostik sexuell übertragbarer Infektionen“ statt. Das Ziel dieser Tagung war, die in einem vorangegangenen Treffen im Januar 2012 erarbeitete Bewertung der Schnelltests für den Einsatz in der Infektionsdiagnostik von HIV, HBV, HCV, T. pallidum, C. trachomatis und N. gonorrhoeae in „niedrigschwelligen Einrichtungen“ unter Berücksichtigung neuer Erkenntnisse und Entwicklungen dem aktuellen Stand anzupassen. Die von der Bundesregierung kürzlich beschlossene Strategie zur Eindämmung von HIV, Hepatitis B und C und anderen sexuell übertragbaren Infektionen beschreibt einen Mangel an Testmöglichkeiten und verfolgt eine Steigerung der Testangebote und einen besseren Zugang. Eine wichtige Option um Testbarrieren zu senken, repräsentiert der Einsatz von Schnelltests, die als niedrigschwelliges Testangebot in Beratungsstellen angeboten werden und auch als Heimtests durchgeführt werden können. Basierend auf den in klinischen Studien evaluierten Leistungsmerkmalen sind einige HIV-, HCV- und Syphilis-Schnelltests durchaus als point-of-care Test (POCT) geeignet. Für C. trachomatis und N. gonorrhoeae erreichen nur PCR-basierte POCTs eine ausreichende diagnostische Genauigkeit. Der Einsatz von Schnelltest ist in Deutschland an bestimmte Vorgaben des IfSG und MPG gebunden. Die Abgabe von HIV-Diagnostika an Privatpersonen (zwecks Heimtestung) ist in Deutschland untersagt (§ 11, MPG). Die Feststellung und Übermittlung einer Infektionskrankheit ist einem Arzt vorbehalten und darf auch nicht als Ferndiagnose erfolgen (§ 24, IfSG). Darüber hinaus unterliegen Schnelltests, wie alle labormedizinischen Analysen einer Qualitätssicherung entsprechend den Richtlinien der Bundesärztekammer

High Prevalence and High Incidence of Coinfection with Hepatitis B, Hepatitis C, and Syphilis and Low Rate of Effective Vaccination against Hepatitis B in HIV-Positive Men Who Have Sex with Men with Known Date of HIV Seroconversion in Germany

Objectives: Men who have sex with men (MSM) are at higher risk for coinfection with hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis than the general population. HIV infection and these coinfections accelerate disease progression reciprocally. This study evaluated the prevalence and incidence of these coinfections in HIV1-positive MSM in Germany. Materials and Methods: As part of a nationwide, multicenter, prospective cohort study of HIV-infected MSM, plasma samples collected yearly were screened for HBsAg and antibodies to HBc, HBs, HCV, and syphilis. Samples with indications of active HBV or HCV infection were confirmed by polymerase chain reaction. Prevalence and incidence of each infection and incidence rates per study participant were calculated, and incidences over 4-year time intervals compared. Results: This study screened 5,445 samples from 1,843 MSM. Median age at HIV seroconversion was 33 years. Prevalences of active, cleared, and occult HBV, and of active/cleared HCV were 1.7%, 27.1%, 0.2%, and 8.2%, respectively, and 47.5% had been effectively vaccinated against HBV. Prevalence of antibodies to Treponema pallidum and of triple or quadruple sexually transmitted infections (STIs) were 39.6% and 18.9%, respectively. Prevalence of STI, cleared HBV, HBV vaccination, and history of syphilis differed significantly among age groups. Incidences of HBV, HCV, and syphilis were 2.51, 1.54, and 4.06 per 100 person-years, respectively. Incidences of HCV and syphilis increased over time. HCV incidence was significantly higher in MSM coinfected with syphilis and living in Berlin, and syphilis incidence was significantly higher for MSM living in Berlin. Discussion: Despite extensive HBV vaccination campaigns, fewer than 50% of screened MSM were effectively vaccinated, with a high proportion of HIV-positive MSM coinfected with HBV. High rates of STI coinfections in HIV-positive MSM and increasing incidences emphasize the need for better tailored campaigns for HBV vaccination and STI prevention

Prevalences of hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis in MSM with the HIV-seroconversion cohort, by infection status and age at HIV seroconversion (N = 1,838).

<p>¹For classification of samples as positive for each specific infection see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0142515#pone.0142515.t001" target="_blank">Table 1</a></p><p>²Comparison by X²-test or Fisher’s exact test, where necessary.</p><p>Prevalences of hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis in MSM with the HIV-seroconversion cohort, by infection status and age at HIV seroconversion (N = 1,838).</p

Prevalences of coinfections in MSM of the HIV seroconverter cohort.

<p>The figure shows coinfections with hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis. The areas of the ellipses correspond to the calculated proportions of the respective coinfections. White numbers: proportions of respective multiple infections. All percentages are relative to the total number of HIV-positive MSM (N = 1,838). The category “HBV” comprises HIV-positive MSM testing positive for an active, cleared, or occult HBV coinfection; the category “HCV” comprises HIV-positive MSM testing positive for an acute/chronic or cleared HCV-coinfection (for a definition on the basis of the serological testing results of these categories, see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0142515#pone.0142515.t001" target="_blank">Table 1</a>).</p

Incidence rate ratios (IRR) of coinfections in MSM of the HIV seroconverter cohort.

<p>IRR for infection with hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis were calculated for persons living in Berlin and those living elsewhere in Germany and in persons testing positive for syphilis at any time point or and those always testing negative. Whisker graphs show lower and upper limits of calculated 95% confidence intervals.</p

Characteristics of the study population (for prevalence analysis), and of subpopulations assorted by coinfection with HBV, HCV, and syphilis (containing study participants available for incidence analyses).

<p>Characteristics of the study population (for prevalence analysis), and of subpopulations assorted by coinfection with HBV, HCV, and syphilis (containing study participants available for incidence analyses).</p

High Prevalence and High Incidence of Coinfection with Hepatitis B, Hepatitis C, and Syphilis and Low Rate of Effective Vaccination against Hepatitis B in HIV-Positive Men Who Have Sex with Men with Known Date of HIV Seroconversion in Germany

Men who have sex with men (MSM) are at higher risk for coinfection with hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis than the general population. HIV infection and these coinfections accelerate disease progression reciprocally. This study evaluated the prevalence and incidence of these coinfections in HIV1-positive MSM in Germany.As part of a nationwide, multicenter, prospective cohort study of HIV-infected MSM, plasma samples collected yearly were screened for HBsAg and antibodies to HBc, HBs, HCV, and syphilis. Samples with indications of active HBV or HCV infection were confirmed by polymerase chain reaction. Prevalence and incidence of each infection and incidence rates per study participant were calculated, and incidences over 4-year time intervals compared.This study screened 5,445 samples from 1,843 MSM. Median age at HIV seroconversion was 33 years. Prevalences of active, cleared, and occult HBV, and of active/cleared HCV were 1.7%, 27.1%, 0.2%, and 8.2%, respectively, and 47.5% had been effectively vaccinated against HBV. Prevalence of antibodies to Treponema pallidum and of triple or quadruple sexually transmitted infections (STIs) were 39.6% and 18.9%, respectively. Prevalence of STI, cleared HBV, HBV vaccination, and history of syphilis differed significantly among age groups. Incidences of HBV, HCV, and syphilis were 2.51, 1.54, and 4.06 per 100 person-years, respectively. Incidences of HCV and syphilis increased over time. HCV incidence was significantly higher in MSM coinfected with syphilis and living in Berlin, and syphilis incidence was significantly higher for MSM living in Berlin.Despite extensive HBV vaccination campaigns, fewer than 50% of screened MSM were effectively vaccinated, with a high proportion of HIV-positive MSM coinfected with HBV. High rates of STI coinfections in HIV-positive MSM and increasing incidences emphasize the need for better tailored campaigns for HBV vaccination and STI prevention