scholarly journals Sensitivity and Specificity of Treponemal-specific Tests for the Diagnosis of Syphilis

2020 ◽  
Vol 71 (Supplement_1) ◽  
pp. S13-S20
Author(s):  
Ina U Park ◽  
Anthony Tran ◽  
Lara Pereira ◽  
Yetunde Fakile
Keyword(s):  
Systematic Review ◽  
Cerebrospinal Fluid ◽  
Sensitivity And Specificity ◽  
Treponema Pallidum ◽  
Secondary Syphilis ◽  
Clinical Scenario ◽  
Test Results ◽  
Insufficient Evidence ◽  
Agglutination Assay ◽  
Particle Agglutination

Abstract We conducted a systematic review of relevant syphilis diagnostic literature to address the question, “What is the sensitivity and specificity of the treponemal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of syphilis (by stage)?” There were 16 treponemal assays evaluated: 13 immunoassays and 3 manual assays (fluorescent treponemal antibody absorbed test [FTA-ABS], microhemagglutination assay for Treponema pallidum antibodies [MHA-TP], Treponema pallidum particle agglutination assay [TP-PA]). MHA-TP and FTA-ABS were less sensitive in primary and secondary syphilis than TP-PA; TP-PA is the most specific manual treponemal assay. There is insufficient evidence to recommend one particular treponemal immunoassay (eg, enzyme immunoassays, chemiluminescence immunoassays, microbead immunoassays) over another based on published performance data. For diagnosis of neurosyphilis, cerebrospinal fluid (CSF) TP-PA has similar performance to CSF FTA-ABS in studies with patients with definitive or presumptive neurosyphilis. However, CSF treponemal testing has limitations in its sensitivity and specificity and should be interpreted within the context of the clinical scenario, additional CSF test results and syphilis prevalence.

scholarly journals Cerebrospinal Fluid Treponema pallidum Particle Agglutination Assay for Neurosyphilis Diagnosis

2017 ◽  
Vol 55 (6) ◽  
pp. 1865-1870 ◽  
Author(s):  
Christina M. Marra ◽  
Clare L. Maxwell ◽  
Shelia B. Dunaway ◽  
Sharon K. Sahi ◽  
Lauren C. Tantalo
Keyword(s):  
Cerebrospinal Fluid ◽  
Vision Loss ◽  
Treponema Pallidum ◽  
Training Data ◽  
Validation Data ◽  
Data Set ◽  
Convenience Sample ◽  
Content Type ◽  
Agglutination Assay ◽  
Particle Agglutination

ABSTRACT Limited data suggest that the cerebrospinal fluid Treponema pallidum particle agglutination assay (CSF-TPPA) is sensitive and a CSF Treponema pallidum hemagglutination assay (CSF-TPHA) titer of ≥1:640 is specific for neurosyphilis diagnosis. CSF-TPPA reactivity and titer were determined for a convenience sample of 191 CSF samples from individuals enrolled in a study of CSF abnormalities in syphilis (training data set). The sensitivity of a reactive test and the specificity for reactivity at serial higher CSF dilutions were determined. Subsequently, CSF-TPPA reactivity at a 1:640 dilution was determined for all available samples from study participants enrolled after the last training sample was collected (validation data set, n = 380). Neurosyphilis was defined as (i) a reactive CSF Venereal Disease Research Laboratory test (CSF-VDRL), (ii) detection of T. pallidum in CSF by reverse transcriptase PCR, or (iii) new vision loss or hearing loss. In the training data set, the diagnostic sensitivities of a reactive CSF fluorescent treponemal antibody absorption test (CSF-FTA-ABS) and a reactive CSF-TPPA did not differ significantly (67 to 98% versus 76 to 95%). The specificity of a CSF-TPPA titer of ≥1:640 was significantly higher than that of lower dilutions and was not significantly different from that of CSF-VDRL. In the validation data set, the diagnostic specificity of a CSF-TPPA titer of ≥1:640 was high and did not differ significantly from that of CSF-VDRL (93 to 94% versus 90 to 91%). Ten CSF samples with a nonreactive CSF-VDRL had a CSF-TPPA titer of ≥1:640. If a CSF-TPPA titer of ≥1:640 was used in addition to a reactive CSF-VDRL, the number of neurosyphilis diagnoses would have increased from 47 to 57 (21.3%). A CSF-TPPA titer cutoff of ≥1:640 may be useful in identifying patients with neurosyphilis when CSF-VDRL is nonreactive.

Evaluation of a Multiplex Fully Automated Treponemal and Nontreponemal (Rapid Plasma Reagin) Assay

2019 ◽  
Vol 152 (2) ◽  
pp. 230-236 ◽  
Author(s):  
Sophie Arbefeville ◽  
Maureen Lynch ◽  
Patricia Ferrieri
Keyword(s):  
Sensitivity And Specificity ◽  
Immunoglobulin G ◽  
Gold Standard ◽  
Treponema Pallidum ◽  
Immunoglobulin M ◽  
Rapid Plasma Reagin ◽  
Agglutination Assay ◽  
Assay Performance ◽  
Card Test ◽  
Particle Agglutination

ABSTRACTObjectivesIn June 2017, Bio-Rad Laboratories received US Food and Drug Administration clearance for its BioPlex 2200 Syphilis Total & RPR (rapid plasma reagin) assay. It is the first fully automated treponemal/nontreponemal multiplex flow immunoassay, simultaneously detecting Treponema pallidum and reagin antibodies and an RPR titer. We compared the performance of the BioPlex Syphilis Total & RPR assay with the LIAISON Treponema Assay and the manual BD Macro-Vue RPR 18-mm Circle Test.MethodsIn total, 314 serum specimens were tested for treponemal immunoglobulin G/immunoglobulin M and RPR with the LIAISON Treponema Assay, the BioPlex 2200 Syphilis Total & RPR assay, and the manual BD Macro-Vue RPR card test. All discordant results were further tested with the T pallidum particle agglutination assay from Fujirebio Diagnostics.ResultsThe overall percent agreement for the BioPlex assay for treponemal antibodies with the LIAISON Treponema Assay was 96.1%. Sensitivity and specificity for the BioPlex RPR assay were 90.5% and 97.2%, respectively (the manual RPR assay was considered the gold standard).ConclusionsThe BioPlex 2200 Syphilis Total & RPR assay performance was comparable to the LIAISON Treponema Assay and the manual RPR test. Compared with the manual RPR, the automation of RPR testing offered labor savings, objective result reporting, and improved workflow.

scholarly journals Evaluation of Two Immunoblot Assays and a Western Blot Assay for the Detection of Antisyphilis Immunoglobulin G Antibodies

2009 ◽  
Vol 17 (1) ◽  
pp. 183-184 ◽  
Author(s):  
Ryan J. Welch ◽  
Christine M. Litwin
Keyword(s):  
Western Blot ◽  
Immunoglobulin G ◽  
Treponema Pallidum ◽  
Absorption Test ◽  
Rapid Plasma Reagin ◽  
Western Blot Assay ◽  
Agglutination Assay ◽  
Antibody Absorption ◽  
Particle Agglutination

ABSTRACT In the present study, two immunoglobulin G (IgG) immunoblot assays and one IgG Western blot assay were compared to the rapid plasma reagin test (RPR), the fluorescent treponemal antibody absorption test (FTA-ABS), and the Treponema pallidum particle agglutination assay (TP-PA). The agreement levels of the Viramed, Virotech, and MarDx assays were 97.0%, 96.4%, and 99.4%, and the agreements of samples inconclusive by FTA-ABS and resolved by TP-PA were 91.7%, 83.3%, and 69.4%, respectively.

scholarly journals Characterization of Sera with Discordant Results from Reverse Sequence Screening for Syphilis

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Kyunghoon Lee ◽  
Hyewon Park ◽  
Eun Youn Roh ◽  
Sue Shin ◽  
Kyoung Un Park ◽  
...  
Keyword(s):  
Treponema Pallidum ◽  
Screening Tests ◽  
Rapid Plasma Reagin ◽  
Agglutination Assay ◽  
Reverse Sequence ◽  
National University ◽  
Seoul National University ◽  
Particle Agglutination

Reverse sequence screening for syphilis (RSSS) (screening with treponemal tests, followed by confirmation with nontreponemal tests) has been increasingly adopted. CDC recommends confirmation of discordant results (reactive EIA/CIA and nonreactive nontreponemal test) withTreponema pallidumparticle agglutination assay (TP-PA). We characterized sera with discordant results from RSSS with Architect Syphilis TP CIA. Among 15,713 screening tests using Architect Syphilis TP at Seoul National University Gangnam Center between October 2010 and May 2011, 260 (1.7%) showed reactive results. Rapid plasma reagin (RPR) and TP-PA were performed on 153 available sera among them. On sera with discordant results between Architect Syphilis TP and TP-PA, INNO-LIA Syphilis Score and FTA-ABS were performed. Among 153 sera, RPR was nonreactive in 126 (82.4%). Among them, TP-PA was positive in 103 (81.7%), indeterminate (±) in 7 (5.6%), and negative in 16 (12.7%). Out of 16 CIA(+)/RPR(−)/TP-PA(−) sera, INNO-LIA Syphilis Score and/or FTA-ABS were negative on 14 sera. Out of 7 CIA(+)/RPR(−)/TP-PA(±) sera, INNO-LIA Syphilis Score and FTA-ABS were positive/reactive in 6 sera. RSSS with confirmation by TP-PA on sera with discordant results between Architect Syphilis TP and RPR effectively delineated those discordant results and could be successfully adopted for routine checkup for syphilis.

scholarly journals Neurosyphilis Manifesting With Bilateral Adie’s Pupil: A Case Report

2019 ◽  
Author(s):  
Ya-ping Zhou ◽  
Ji-Wei Jiang ◽  
Mei-qing Lin ◽  
Mei-Xin Li ◽  
Xiu-Li Shang
Keyword(s):  
Cerebrospinal Fluid ◽  
Case Report ◽  
Treponema Pallidum ◽  
Final Diagnosis ◽  
Case Presentation ◽  
Elevated Protein ◽  
Syphilis Treatment ◽  
Syphilis Screening ◽  
Particle Agglutination ◽  
Csf Examination

Abstract Background Pupillary abnormalities play an important role in identification of neurosyphilis. Among them, Argyll Roberston pupil is most typical and has been mentioned in many reports and studies. However, papers about Adie’s pupil associated with neurosyphilis are extremely rare. In the present study, we report a case of patient with bilateral Adie’s pupils as isolated manifestation of neurosyphilis. Case presentation we describe a 58-year-old retired Chinese woman with bilateral Adie’s pupils. Further evaluation revealed serologically positive for Treponema pallidum particle agglutination (TPPA), chemiluminescence immunoassays (CLIA) and rapid plasma regain (RPR) test (1:16). The Cerebrospinal fluid (CSF) examination revealed pleocytosis, elevated protein, and positive RPR (1:2), TPPA and CLIA. Final diagnosis of Adie’s pupils associated with neurosyphilis was made and other possible causes were excluded. Cephalosporin was used for treatment due to penicillin allergy. Despite effective anti-syphilis treatment, her pupils remained unchanged. Conclusions Adie’s pupil can be caused by neurosyphilis and is one of the most important pupillary changes in early neurosyphilis. Our study further underscore the necessity of syphilis screening in patients with Adie’s pupil due to further treatment consideration.

scholarly journals Diagnostic test accuracy of Xpert MTB/RIF for tuberculous pericarditis: a systematic review and meta-analysis

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 761
Author(s):  
Andrianto Andrianto ◽  
Ni Made Mertaniasih ◽  
Parama Gandi ◽  
Makhyan Jibril Al-Farabi ◽  
Yusuf Azmi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sensitivity And Specificity ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Test Accuracy ◽  
Test Results ◽  
Likelihood Ratios ◽  
Bivariate Model ◽  
Cross Sectional ◽  
Sensitivity Specificity

Introduction: Xpert MTB/RIF is a rapid diagnostic instrument for pulmonary tuberculosis (TB). However, studies reported varied accuracy of Xpert MTB/RIF in detecting Mycobacterium tuberculosis in pericardial effusion. Methods: We performed a systematic review of literature in PubMed, published up to February 1, 2020, according to PRISMA guidelines. We screened cross-sectional studies, observational cohort studies, and randomized control trials that evaluated the accuracy of Xpert MTB/RIF in diagnosing TB pericarditis. Papers with noninterpretable results of sensitivity and specificity, non-English articles, and unpublished studies were excluded. The primary outcomes were the sensitivity and specificity of Xpert MTB/RIF. We conducted a quality assessment using QUADAS-2 to evaluate the quality of the studies. A bivariate model pooled the overall sensitivity, specificity, positive likelihood ratios (PLRs), and negative likelihood ratios (NLRs) of included studies. Results: In total, 581 subjects from nine studies were analyzed in this meta-analysis. Our pooled analysis showed that the overall sensitivity, specificity, PLRs and NLRs of included studies were 0.676 (95% CI: 0.580–0.759), 0.994 (95% CI: 0.919–1.000), 110.11 (95% CI: 7.65–1584.57) and 0.326 (95% CI: 0.246–0.433), respectively. Conclusions: Xpert MTB/RIF had a robust specificity but unsatisfactory sensitivity in diagnosing TB pericarditis. These findings indicated that although positive Xpert MTB/RIF test results might be valuable in swiftly distinguishing the diagnosis of TB pericarditis, negative test results might not be able to rule out TB pericarditis. Registration: PROSPERO CRD42020167480 28/04/2020

scholarly journals Clinical Test Performance of a Rapid Point-of-Care Syphilis Treponemal Antibody Test: A Systematic Review and Meta-analysis

2020 ◽  
Vol 71 (Supplement_1) ◽  
pp. S52-S57
Author(s):  
Claire C Bristow ◽  
Jeffrey D Klausner ◽  
Anthony Tran
Keyword(s):  
Systematic Review ◽  
Sensitivity And Specificity ◽  
Test Performance ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Meta Analysis ◽  
Treponema Pallidum ◽  
Antibody Test ◽  
Health Check ◽  
Clinical Test

Abstract We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, “What is the sensitivity and specificity of the Syphilis Health Check, a rapid qualitative test for the detection of human antibodies to Treponema pallidum.” The Syphilis Health Check is the only rapid syphilis test currently cleared by the Food and Drug Administration (FDA). We conducted a systematic review and a meta-analysis using Bayesian bivariate random-effects and fixed-effect models to create pooled estimates of sensitivity and specificity of the Syphilis Health Check. We identified 5 test evaluations published in the literature and 10 studies submitted to the FDA and for a Clinical Laboratory Improvement Amendments waiver application. The pooled sensitivity (95% CI) from the laboratory evaluations (n = 5) was 98.5% (92.1–100%), while pooled specificity was 95.9% (81.5–100.0%). The pooled sensitivity for prospective studies (n = 10) was 87.7% ( 71.8–97.2%), while pooled specificity was 96.7% (91.9–99.2%). Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8–98.6%). The Syphilis Health Check may provide accurate detection of treponemal antibody.

scholarly journals Detección de Treponema pallidum subespecie pallidum para el diagnóstico de sífilis congénita mediante reacción en cadena de la polimerasa anidada

Biomédica ◽  
2018 ◽  
Vol 38 (1) ◽  
pp. 128 ◽  
Author(s):  
Gladys Pinilla ◽  
Lesly Campos ◽  
Andrea Durán ◽  
Jeannette Navarrete ◽  
Liliana Muñoz
Keyword(s):  
Research Laboratory ◽  
Venereal Disease ◽  
Treponema Pallidum ◽  
Venereal Disease Research Laboratory ◽  
Rapid Plasma Reagin ◽  
Agglutination Assay ◽  
Disease Research ◽  
Particle Agglutination

Introducción. La sífilis es una enfermedad producida por Treponema pallidum subespecie pallidum cuya incidencia mundial es de 12 millones de casos por año, aproximadamente; de estos, más de dos millones se presentan en mujeres gestantes, siendo la sífilis congénita la complicación más grave de esta infección en el embarazo.Objetivo. Detectar la presencia de T. pallidum subespecie pallidum en muestras clínicas para el diagnóstico de sífilis congénita mediante reacción en cadena de la polimerasa (PCR) anidada y determinar su concordancia con las pruebas serológicas.Materiales y métodos. Mediante PCR convencional y anidada, se amplificaron tres genes diana (polA, 16S ADNr y TpN47) y se confirmaron los productos de amplificación de los genes TpN47 y polA por secuenciación. Las pruebas serológicas empleadas fueron la VDRL (Venereal Disease Research Laboratory), la de reagina plasmática rápida (Rapid Plasma Reagin, RPR) y la de aglutinación de partículas para Treponema pallidum (Treponema pallidum Particle Agglutination Assay, TPPA).Resultados. La sensibilidad para la PCR convencional fue de 52 pg y, para la PCR anidada, de 0,52 pg. La especificidad con los iniciadores TpN47 y polA fue de 100 %; los resultados de la secuenciación mostraron una identidad de 97 % con T. pallidum. En 70 % de las muestras, los resultados de las pruebas serológicas y la PCR anidada concordaron.Conclusión. El gen TpN47 resultó ser el mejor blanco molecular para la identificación de T. pallidum. La PCR anidada se presenta como una alternativa de diagnóstico molecular promisoria para el diagnóstico de sífilis congénita.

scholarly journals Characterization of Treponema pallidum Particle Agglutination Assay-Negative Sera following Screening by Treponemal Total Antibody Enzyme Immunoassays

2010 ◽  
Vol 17 (11) ◽  
pp. 1718-1722 ◽  
Author(s):  
P. A. C. Maple ◽  
D. Ratcliffe ◽  
E. Smit
Keyword(s):  
Venereal Disease ◽  
Treponema Pallidum ◽  
Hiv Positive ◽  
Immunoblot Assay ◽  
Agglutination Assay ◽  
Disease Research ◽  
Confirmatory Assay ◽  
Particle Agglutination

ABSTRACT Following a laboratory audit, a significant number of Treponema pallidum particle agglutination assay (TPPA)-negative sera were identified when TPPA was used as a confirmatory assay of syphilis enzyme immunoassay (EIA) screening-reactive sera (SSRS). Sera giving such discrepant results were further characterized to assess their significance. A panel of 226 sera was tested by the Abbott Murex ICE Syphilis EIA and then by the Newmarket Syphilis EIA II. TPPA testing was performed on 223 sera. Further testing by the Venereal Disease Research Laboratory (VDRL) test, the Mercia Syphilis IgM EIA, the fluorescent treponemal antibody (FTA-ABS) assay, and INNO-LIA immunoblotting was undertaken in discrepant cases. One hundred eighty-seven of 223 (83.8%) SSRS were TPPA reactive, while 26 (11.6%) sera which were reactive in both the ICE and Newmarket EIAs were nonreactive by TPPA. The majority (68%) of the TPPA-discrepant sera were from HIV-positive patients and did not represent early acute cases, based on previous or follow-up samples, which were available for 22/26 samples. FTA-ABS testing was performed on 24 of these sera; 14 (58.3%) were FTA-ABS positive, and 10 (41.7%) were FTA-ABS negative. Twenty-one of these 26 sera were tested by INNO-LIA, and an additional 4 FTA-ABS-negative samples were positive. In this study, significant numbers (18/26) of SSRS- and TPPA-negative sera were shown by further FTA-ABS and LIA (line immunoblot assay) testing to be positive. The reason why certain sera are negative by TPPA but reactive by treponemal EIA and other syphilis confirmatory assays is not clear, and these initial findings should be further explored.

Evaluation of two automated chemiluminescence immunoassays, the LIAISON Treponema Screen and the ARCHITECT Syphilis TP, and the Treponema pallidum particle agglutination test for laboratory diagnosis of syphilis

2011 ◽  
Vol 49 (8) ◽  
Author(s):  
Nele Wellinghausen ◽  
Hanna Dietenberger
Keyword(s):  
Prospective Study ◽  
Pregnant Women ◽  
Sensitivity And Specificity ◽  
Screening Test ◽  
Treponema Pallidum ◽  
Laboratory Diagnosis ◽  
Agglutination Test ◽  
Diagnostic Laboratory ◽  
Diagnostic Sensitivity And Specificity ◽  
Particle Agglutination

AbstractAutomatedWe evaluated the LIAISON Treponema Screen (LIA) and the ARCHITECT Syphilis TP (ARCH) in comparison to theIn the prospective study, the sensitivity and specificity of LIA, ARCH, and TPPA were 100% (18/18), 100% (17/17), and 100% (18/18), and 100% (558/558), 99.8% (552/553), and 99.6% (556/558), respectively. In pregnant women, the specificity of LIA and ARCH was 100% (317/317) and of TPPA 99.7% (316/317). One sample from a child with assumed exposure to maternal antitreponemal antibodies was omitted from analysis. LIA, ARCH, and TPPA were also positive in all investigated sera from patients with known syphilis.Both automated CLIA demonstrated excellent diagnostic sensitivity and specificity when evaluated as a screening test for syphilis under routine conditions of a diagnostic laboratory. Thus, these may be used independently as an alternative to the manual TPPA screen.

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