British Columbia’s Experience after Implementation of the Treponema pallidum Reverse Algorithm and PCR Detection, 2015 to 2020

Morshed, Muhammad; Lee, Min-Kuang; Laley, Jonathan; Cook, Darrel; Mak, Annie; Chahil, Navdeep; Ryan, Venessa; Montgomery, Carolyn A.; Makaroff, S; Malleson, Sarah; Arnold, Barbra; Grennan, Troy; Wong, Jason; Krajden, Mel

doi:10.1128/spectrum.00686-22

Cited by 5 publications

(1 citation statement)

References 26 publications

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“…The reverse algorithm starts with a specific treponemal test, and if positive (or reactive), samples are confirmed by a nontreponemal test. Discordant samples are resolved with a second specific treponemal test, preferably based on different antigens than the original treponemal test [7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Serological follow-up after syphilis diagnosis in Israel

Grauenfels Cohen,

Cohen,

Dveyrin

et al. 2024

Epidemiol. Infect.

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The global incidence of syphilis is increasing. Continuity of care challenges the control of sexually transmitted diseases. In this study, we assessed the follow-up and serological decline differences between community- and hospital-diagnosed patients in Israel. A historical cohort study was conducted using the Israel National Syphilis Center (NSC) repository. Patients with a positive non-specific Venereal Disease Research Laboratory (VDRL) test between 2011 and 2020 were included. Rates of serological follow-up and serological titre decreases were compared between hospital- and community-diagnosed patients. The study included 4,445 patients, 2,596 (58.4%) were diagnosed in community clinics and 1,849 (41.6%) in hospitals. Of community-diagnosed patients, 1,957 (75.4%) performed follow-up testing, compared with 834 (51.2%) hospital-diagnosed patients (p < 0.001). On multivariate analysis, the odds ratio of serology follow-up among community-diagnosed patients was 2.8 (95 per cent confidence interval (95% CI): 2.2–3.5) that of hospital-diagnosed patients. There were 1,397 (71.4%) community-diagnosed patients with serological titre decrease, compared with 626 (74.9%) hospital-diagnosed patients (p = 0.03). On multivariate analysis, this difference diminished. Serological follow-up testing is suboptimal and was performed more often among patients initially diagnosed in the community compared to hospitals. Continuity of care should be improved to promote successful patient care and prevent disease spread.

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Section: Introductionmentioning

confidence: 99%

Serological follow-up after syphilis diagnosis in Israel

Grauenfels Cohen,

Cohen,

Dveyrin

et al. 2024

Epidemiol. Infect.

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A multi-country comparative study of two treponemal tests for the serodiagnosis of syphilis amongst men who have sex with men (MSM): Chemo-luminescent assay vs Treponema pallidum particle agglutination assay

Gios,

Mirandola,

Cordioli

et al. 2024

BMC Infect Dis

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Introduction International guidelines recommend routine screening for syphilis (aetiological agent: Treponema pallidum subspecies pallidum) amongst key populations and vulnerable populations using tests detecting treponemal and non-treponemal antibodies. Whilst treponemal tests have high sensitivities and specificities, they differ regarding subjective or objective interpretation, throughput and workload. Chemiluminescence immunoassays (CLIAs) are cost- and time-effective automated methods for detecting treponemal antibodies. The Treponema pallidum particle agglutination assay (TPPA) has been considered the “gold standard” treponemal assay, however, this includes a highly manual procedure, low throughput and subjective interpretation. The present multi-country study evaluated the ADVIA Centaur® Syphilis CLIA (Siemens Healthcare) assay compared to the reference SERODIA-TP·PA® (Fujirebio Diagnostics) for the serodiagnosis of syphilis amongst men who have sex with men (MSM). Method 1,485 MSM were enrolled in Brighton (UK), Malta, and Verona (Italy) as part of a larger WHO multi-country and multi-site ProSPeRo study. Ethical approval was obtained. Serum was tested with the ADVIA Centaur® Syphilis CLIA assay and SERODIA-TP·PA®, in accordance with the manufacturers’ instructions, for a first round of validation. A second round of validation was carried out for discrepant results that were additionally tested with both Western Blot (Westernblot EUROIMMUN®) and an Immunoblot (INNO-LIA, Fujirebio Diagnostics). Sensitivity, specificity, positive and negative predictive value (PPV and NPV), likelihood ratios (positive/negative), and the Diagnostic Odds Ratio (DOR)/pre-post-test probability (Fagan's nomogram) were calculated. Results Out of 1,485 eligible samples analysed in the first phase, the SERODIA-TP·PA® identified 360 positive and 1,125 negative cases. The ADVIA Centaur® Syphilis CLIA assay (Siemens) identified 366 positives, missclassifying one TPPA-positive sample. In the second phase, the ADVIA Centaur® Syphilis CLIA resulted in 1 false negative and 4 false positive results. Considering the syphilis study prevalence of 24% (95% CI: 22–26.7), The sensitivity of the ADVIA Centaur® Syphilis CLIA assay was 99.7% (95% CI: 98.5–100), and the specificity was 99.4% (95% CI: 98.7–99.7). The ROC area values were 0.996 (95% CI: 0.992–0.999), and both the PPV and NPV values were above 98% (PPV 98.1%, 95% CI: 96.1–99.2; NPV 99.9%, 95% CI: 99.5–100). Conclusions The ADVIA Centaur® Syphilis CLIA assay showed similar performance compared to the SERODIA-TP·PA®. Considering the study is based on QUADAS principles and with a homogeneous population, results are also likely to be generalisable to MSM population but potentially not applicable to lower prevalence populations routinely screened for syphilis. The automated CLIA treponemal assay confirmed to be accurate and appropriate for routine initial syphilis screening, i.e. when the reverse testing algorithm is applied.

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A multi-country comparative study of two treponemal tests for the serodiagnosis of Syphilis amongst Men Who Have Sex with Men (MSM): Chemo-luminescent assay vs Treponema pallidum passive particle agglutination assay

Gios

Mirandola

Cordioli

et al. 2023

Preprint

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Introduction: International guidelines recommend routine screening for syphilis (aetiological agent: Treponema pallidum subspecies pallidum) amongst key populations and vulnerable populations using tests detecting treponemal and non-treponemal antibodies. Whilst treponemal tests have high sensitivities and specificities, they differ regarding subjective or objective interpretation, throughput and workload. Chemiluminescence immunoassays (CLIAs) are cost- and time-effective automated methods for detecting treponemal antibodies. The Treponema pallidum passive particle agglutination assay (TPPA) has been considered the “gold standard” treponemal assay, however, this includes a highly manual procedure, low throughput and subjective interpretation. The present multi-country study evaluated the ADVIA Centaur® Syphilis CLIA assay compared to the reference SERODIA-TP·PA® for the serodiagnosis of syphilis amongst men who have sex with men (MSM). Method: 1,485 MSM were enrolled in Brighton (UK), Malta, and Verona (Italy) as part of a larger WHO multi-country and multi-site ProSPeRo study. Ethical approval was obtained. Serum was tested with the ADVIA Centaur® Syphilis CLIA assay (Siemens) and SERODIA-TP·PA® (Fujirebio), in accordance with the manufacturers’ instructions, for a first round of validation. A second round of validation was carried out for discrepant results that were additionally tested with both Western Blot (Westernblot EUROIMMUN ®) and an Immunoblot (INNO-LIA, Fujirebio Diagnostics). Sensitivity, specificity, positive and negative predictive value (PPV and NPV), likelihood ratios (positive/negative), and the Diagnostic Odds Ratio (DOR)/pre-post-test probability (Fagan's nomogram) were calculated. Results: Out of 1,485 eligible samples analysed in the first phase, the SERODIA-TP·PA® (Fujirebio) identified 360 positive and 1,125 negative cases. The ADVIA Centaur® Syphilis CLIA assay (Siemens) identified 366 positives, missclassifying one TPPA-positive sample. In the second phase, the ADVIA CLIA resulted in 1 false negative and 4 false positive results. Considering the syphilis study prevalence of 24% (95% CI: 22-26.7), the sensitivity and specificity of the CLIA in the second phase was 99.7% (95% CI: 97.9-100) and 99.5% (95% CI: 98.8-99.8), respectively. The area under the ROC curve was 0.997 (95% CI: 0.994-1). The PPV and NPV was 98.9% (95% CI: 97.2-99.7) and 99.9% (95% CI: 99.5-100), respectively. Conclusions: The ADVIA Centaur® Syphilis CLIA assay showed similar performance compared to the SERODIA-TP·PA®. Considering the study is based on QUADAS principles and with a homogeneous population, results are also likely to be generalisable. The automated CLIA treponemal assay confirmed to be accurate and appropriate for routine initial syphilis screening, i.e. when the reverse testing algorithm is applied. Ethics: Prior to enrolment, the research protocol was independently peer reviewed and approved by both the WHO and the site Research Ethics Committee. Participants were enrolled after signing informed consent.

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British Columbia’s Experience after Implementation of the Treponema pallidum Reverse Algorithm and PCR Detection, 2015 to 2020

Cited by 5 publications

References 26 publications

Serological follow-up after syphilis diagnosis in Israel

Serological follow-up after syphilis diagnosis in Israel

A multi-country comparative study of two treponemal tests for the serodiagnosis of syphilis amongst men who have sex with men (MSM): Chemo-luminescent assay vs Treponema pallidum particle agglutination assay

A multi-country comparative study of two treponemal tests for the serodiagnosis of Syphilis amongst Men Who Have Sex with Men (MSM): Chemo-luminescent assay vs Treponema pallidum passive particle agglutination assay

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