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 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 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.

Evaluation of the Serodia Treponema pallidum particle agglutination, the Murex Syphilis ICE and the Enzywell TP tests for serodiagnosis of syphilis

2005 ◽  
Vol 16 (4) ◽  
pp. 294-298 ◽  
Author(s):  
G Aktas ◽  
H Young ◽  
A Moyes ◽  
S Badur
Keyword(s):  
Enzyme Immunoassay ◽  
False Positive ◽  
Treponema Pallidum ◽  
Routine Laboratory ◽  
Rapid Plasma Reagin ◽  
Serum Samples ◽  
Agglutination Assay ◽  
Serodiagnosis Of Syphilis ◽  
Laboratory Protocol ◽  
Particle Agglutination

We evaluated the Treponema pallidum haemagglutination assay (TPHA), a treponemal test, with three other treponemal tests, the Serodia T. pallidum particle agglutination assay, the Murex Syphilis ICE IgG + IgM enzyme immunoassay (EIA) and the Enzywell TP IgG + M EIA (a new rapid EIA) for use in conjunction with the rapid plasma reagin test (RPR), a non-treponemal test, for serodiagnosis of syphilis. In all, 124 serum samples were found reactive with RPR and/or TPHA after testing by the routine laboratory protocol. Twenty-three (18.5%) of them were positive only by RPR test and were evaluated as biologically false-positive, 16 were positive only by the TPHA and 84 by both the RPR and TPHA tests; one sample was non-specific (heterophile reaction) in the TPHA. Agreements of the TPHA with the Serodia TPPA, the Murex Syphilis ICE and the Enzywell TP tests were 96.7%, 100% and 99.1%, respectively. We conclude that each one of the tests, the Serodia TPPA, the Murex Syphilis ICE and the Enzywell TP, is an appropriate substitute for screening for serodiagnosis of syphilis.

scholarly journals Comparison of the Serodia Treponema pallidum Particle Agglutination, Captia Syphilis-G, and SpiroTek Reagin II Tests with Standard Test Techniques for Diagnosis of Syphilis

2000 ◽  
Vol 38 (7) ◽  
pp. 2543-2545 ◽  
Author(s):  
Victoria Pope ◽  
Martha B. Fears ◽  
William E. Morrill ◽  
Arnold Castro ◽  
Susan E. Kikkert
Keyword(s):  
Enzyme Immunoassay ◽  
Screening Test ◽  
Treponema Pallidum ◽  
Standard Test ◽  
Rapid Plasma Reagin ◽  
Serum Samples ◽  
Card Test ◽  
Particle Agglutination

We compared the microhemagglutination assay for Treponema pallidum (MHA-TP), a treponemal test, with two other treponemal tests, the Serodia Treponema pallidum particle agglutination (TP-PA) assay and the Captia Syphilis-G enzyme immunoassay, using 390 clinical serum samples. We also compared two nontreponemal tests, the rapid plasma Reagin (RPR) card test and the SpiroTek Reagin II test. Agreements of the MHA-TP with the TP-PA test and the Syphilis-G test were 97.4 and 97.7%, respectively. There was 89.2% agreement between the RPR and Reagin II tests. The Reagin II test was more apt to be reactive if the treponemal test was also reactive. We conclude that either the Serodia TP-PA test or the Captia Syphilis-G test is an appropriate substitute for the MHA-TP and that the Spirotek Reagin II test could substitute for the RPR test as a screening test.

scholarly journals Investigation of the rapid immunochromatographic test performance in the diagnosis of syphilis; comparison of four serological methods

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Huseyin Agah Terzi ◽  
Ozlem Aydemir ◽  
Engin Karakece ◽  
Huseyin Hatipoglu ◽  
Mehmet Olmez ◽  
...  
Keyword(s):  
Test Performance ◽  
Gold Standard ◽  
Treponema Pallidum ◽  
Rapid Test ◽  
Immunochromatographic Test ◽  
Rapid Plasma Reagin ◽  
Serum Samples ◽  
Hemagglutination Assay ◽  
Predictive Values ◽  
Sensitivity Specificity

AbstractObjectivesTo test the performance of the newly available rapid test for syphilis, we compared it with Treponema pallidum hemagglutination assay (TPHA). Additionally, we investigated the performance of rapid plasma reagin (RPR) and chemiluminescence microparticle immunoassays (CMIA) at our laboratory using TPHA as a gold standard.MethodsThe serum samples of 595 patients with the pre-diagnosis of syphilis were studied by four serological methods. The sensitivity, specificity, and predictive values of RPR, CMIA, and syphilis rapid test were assessed by utilizing TPHA as a gold standard for the diagnosis of syphilis.ResultsOf the patients, 6.2% (37/595) had positive RPR, 5.5% (33/595) had positive CMIA, 5.5% (33/595) had a positive rapid immunochromatographic method and 5% (30/595) had positive TPHA. When TPHA results were taken as the reference, the sensitivity of the rapid test for syphilis was 100%, the specificity was 99.5%, PPV was 90.9%, and NPV was 100.0%.ConclusionsIt was observed that the rapid test for syphilis used in the study was quite successful, its cost was appropriate, and the test was very fast and easy to apply. At the same time, the agreement between syphilis rapid test and TPHA was found to be excellent.

scholarly journals Developing RT-LAMP Assays for Detection of SARS-CoV-2 in Saliva

2021 ◽  
Author(s):  
Xin Huang ◽  
Gongyu Tang ◽  
Nahed Ismail ◽  
Xiaowei Wang
Keyword(s):  
Sensitivity And Specificity ◽  
Gold Standard ◽  
Reliable Method ◽  
Rapid Test ◽  
Rna Isolation ◽  
Current Crisis ◽  
Design Algorithm ◽  
Assay Performance ◽  
Total Agreement ◽  
S Genes

The coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has killed millions of people worldwide. The current crisis has created an unprecedented demand for rapid test of SARS-CoV-2 infection. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a fast and convenient method to amplify and identify the transcripts of a targeted pathogen. However, the sensitivity and specificity of RT-LAMP were generally regarded as inferior when compared with the gold standard RT-qPCR. To address this issue, we combined bioinformatic and experimental analyses to improve the assay performance for COVID-19 diagnosis. First, we developed an improved algorithm to design LAMP primers targeting the nucleocapsid (N), membrane (M), and spike (S) genes of SARS-CoV-2. Next, we rigorously validated these new assays for their efficacy and specificity. Further, we demonstrated that multiplexed RT-LAMP assays could directly detect as low as a few copies of SARS-CoV-2 RNA in saliva, without the need of RNA isolation. Importantly, further testing using saliva samples from COVID-19 patients indicated that the new RT-LAMP assays were in total agreement in sensitivity and specificity with standard RT-qPCR. In summary, our new LAMP primer design algorithm along with the validated assays provide a fast and reliable method for the diagnosis of COVID-19 cases.

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.

scholarly journals Evaluation of the Bio-Rad BioPlex 2200 Syphilis Multiplex Flow Immunoassay for the Detection of IgM- and IgG-Class Antitreponemal Antibodies

2010 ◽  
Vol 17 (6) ◽  
pp. 966-968 ◽  
Author(s):  
E. Gomez ◽  
D. J. Jespersen ◽  
J. A. Harring ◽  
M. J. Binnicker
Keyword(s):  
Specific Antibody ◽  
Treponema Pallidum ◽  
Random Access ◽  
Laboratory Diagnosis ◽  
Multiplex Assay ◽  
Rapid Plasma Reagin ◽  
Antibody Testing ◽  
Serologic Response ◽  
Antibody Absorption ◽  
Particle Agglutination

ABSTRACT The laboratory diagnosis of syphilis is based primarily upon serologic findings. Historically, serologic testing for syphilis has relied on assays such as rapid plasma reagin, fluorescent treponemal antibody absorption, Treponema pallidum particle agglutination (TP-PA), and more recently, enzyme immunoassay (EIA). In this study, we evaluated the performance of a novel multiplex flow immunoassay (BioPlex 2200 Syphilis; Bio-Rad Laboratories, Hercules, CA) for the detection of antitreponemal IgG- and IgM-class antibodies. Serum specimens (n = 1,008) submitted for routine treponema-specific antibody testing by syphilis IgM and IgG EIA (Trep-Chek; Phoenix-Biotech, Mississauga, Ontario, Canada) were also analyzed by the BioPlex Syphilis multiplex assay. Specimens showing discordant results were repeat tested, with further discrepancies being arbitrated by TP-PA. Compared directly to the results of EIA, the BioPlex IgG assay demonstrated 98.7% (77/78) sensitivity and 99.4% (916/930) specificity. Compared to the Trep-Chek IgM EIA, the BioPlex IgM assay showed 80% (4/5) sensitivity and 97.9% (652/666) specificity. These results indicate that the BioPlex Syphilis multiplex assay shows similar serological agreement with EIA while allowing for a fully automated random-access platform that provides faster (1.7 h for 100 samples versus 4.5 h by EIA) and higher-throughput (800 samples per 9 h versus 200 samples by EIA) analysis of the syphilis serologic response.

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