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

Lee, Kyung-Hoon; Park, Hyewon; Roh, Eun Youn; Shin, Sue; Park, Kyoung Un; Park, Myoung Hee; Song, Eun Young

doi:10.1155/2013/269347

Cited by 14 publications

(14 citation statements)

References 14 publications

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“…In recent years, automated assays to detect TP antibodies and reverse algorithm to detect clinical syphilis have been frequently used (10). However, overtreatment following false-positive test results is known to occur.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Six Automated Treponema-Specific Antibody Assays

et al. 2016

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bSix different Treponema (TP)-specific immunoassays were compared to the fluorescent treponemal antibody absorption (FTA-ABS) test. A total of 615 samples were tested. The overall percent agreement, analytical sensitivity, and analytical specificity of each assay compared to the FTA-ABS test were as follows: Architect Syphilis TP, 99.2%, 96.8%, and 100%; Cobas Syphilis, 99.8%, 99.4%, and 100%; ADVIA Centaur Syphilis, 99.8%, 99.4%, and 100%; HISCL Anti-TP assay kit, 99.7%, 98.7%, and 100%; Immunoticles Auto3 TP, 99.0%, 97.5%, and 99.6%; Mediace TPLA, 98.0%, 98.1%, and 98.0%. All results that were discrepant between the TP-specific assays were associated with samples from noninfectious cases (11 immunoassay false positives and 7 from previous syphilis cases). Our study demonstrated that TP-specific immunoassays generally showed high sensitivities, specificities, and percentages of agreement compared to FTA-ABS, with rare cases of false-positive or false-negative results. Therefore, most TPspecific immunoassays are acceptable for use in screening for syphilis. However, it is important to perform a thorough review of a patient's clinical and treatment history for interpreting the results of syphilis serology. Syphilis is commonly diagnosed on the basis of the results of a combination of serological tests to detect Treponema (TP) antibodies and non-TP antibodies (1). A traditional screening algorithm for syphilis that began with a non-TP assay failed to detect 3% of syphilis cases, in a previous study (2). Recently, a reversescreening algorithm with an automated TP-specific assay has been recommended by the European Centers for Disease Control and Prevention (ECDC) (3). CDC continues to recommend the traditional algorithm and yet also recognizes the recent trend of the widespread use of the reverse algorithm and recommends extra TP tests to resolve discordant results (4). The reverse algorithm has been found to show superior diagnostic performance, with sensitivities ranging from 99.38% to 99.85%, specificities from 99.98% to 100%, and accuracies from 99.93% to 99.96% compared with a 24.2% missed-diagnosis rate and 75.81% sensitivity of the traditional algorithm (5).Various automated TP-specific immunoassays have been developed that use either whole cells or antigens, such as 15TpN, 17TpN, and 47TpN, derived from the Nichols strain of Treponema pallidum, to detect IgG, IgM, or total immunoglobulins (1). Initially, enzyme immunoassays (EIAs) were commonly used to detect TP-specific antibodies (5, 6). However, the use of chemiluminescence immunoassays (CLIAs) to detect TP-specific IgG and IgM antibodies has been gradually increasing (6, 7). Additionally, quantitative TP-specific immunoassays using turbidimetry, based on a latex agglutination method, have been widely used in Asia. However, comparative analyses of the performances of these various methods are lacking.The aim of this study was to evaluate the performances of 6 commonly used TP-specific immunoassays, including CLIAs and turbidimetry assays, in comparison w...

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Section: Discussionmentioning

confidence: 99%

Comparison of Six Automated Treponema-Specific Antibody Assays

et al. 2016

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“…However, old, previously treated infections will also be detected in this initial screening, which can result in excess of testing in high prevalent populations, and high specificity of the treponemal screening test is crucial to avoid false‐positive samples, resulting in low positive predictive values in low prevalent populations. Several validations of the different algorithms have been performed, indicating that the reverse sequence algorithms are preferable where automation is possible, and it will then provide a more sensitive screening and also reduced manual procedures and hence reduce labour costs …”

Section: Discussionmentioning

confidence: 99%

“…Several validations of the different algorithms have been performed, indicating that the reverse sequence algorithms are Evaluation of serological assays for syphilis diagnosis preferable where automation is possible, and it will then provide a more sensitive screening and also reduced manual procedures and hence reduce labour costs. 22,23 In this study, we evaluated six treponemal antibody assays, which can be used in the reverse sequence algorithm. For large scale use, the automated immunoassays and the microplate enzyme immunoassays are suitable for first screening, whilst the TP-PA particle agglutination is more adaptive to be used as a second, confirmatory treponemal assay.…”

Section: Discussionmentioning

confidence: 99%

Analytical evaluation of nine serological assays for diagnosis of syphilis

Malm

Andersson

Fredlund

et al. 2015

Acad Dermatol Venereol

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In resourced settings, where the reverse sequence algorithm is preferred for screening, an automated treponemal immunoassay for initial screening subsequently followed by the TrepSure test or TP-PA assay as a second treponemal assay appear highly effective. Finally, a quantitative highly sensitive non-treponemal assay, e.g. the Macro-Vue RPR Card test, could then be used as a supplementary test to evaluate activity of the syphilis infection.

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“…Among our study samples, 41.6 % was found negative by TP.PA. Other studies conducted in the Republic of Korea and Israel, also using Architect Syphilis TP as the screening test, showed TP.PAnegative rates of 12.7 and 28.3 % among CLIA-positive/ RPR-negative samples [8,14]. The higher rate of TP.PA-negative sera in our study samples can be explained by the fact that only sera with a low Architect Syphilis TP value were included.…”

Section: Discussionmentioning

confidence: 44%

Evaluation of different confirmatory algorithms using seven treponemal tests on Architect Syphilis TP-positive/RPR-negative sera

Jonckheere

Berth

Esbroeck

et al. 2015

Eur J Clin Microbiol Infect Dis

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The Architect Syphilis TP is considered to be a suitable screening test due to its high sensitivity and full automation. According to the International Union against Sexually Transmitted Infections (IUSTI) 2014 guidelines, however, positive screening tests need confirmation with Treponema pallidum particle agglutination (TP.PA). Among Architect-positive results, samples with a negative non-treponemal test present the major diagnostic challenge. In this multicenter study, we investigated if other, preferable less labor-intensive treponemal tests could replace TP.PA. A total of 178 rapid plasma reagin (RPR)-negative sera with an Architect value between 1 and 15 S/CO were prospectively selected in three centers. These sera were analyzed with TP.PA and six alternative treponemal tests: three immunoblots and three tests on random-access analyzers. The diagnostic performance of the treponemal tests differed substantially, with the overall agreement between the six alternative tests ranging from 44.6 to 82.0%. Based on TP.PA as the gold standard, the INNO-LIA IgG blot, the BioPlex 2200 IgG, and the Syphilis TPA showed a high sensitivity, while the EUROLINE-WB IgG blot, recomLine Treponema IgG blot, and the Chorus Syphilis screen showed a high specificity. However, an Architect cut-off of 5.6 S/CO can serve as an alternative for these confirmatory treponemal tests in case of an RPR-negative result. Treponemal tests show poor agreement in this challenging group of Architect-positive/RPR-negative sera. The most optimal algorithm is obtained by assigning sera with an Architect value >5.6 S/CO as true-positives and sera with a value between 1 and 5.6 S/CO as undetermined, requiring further testing with TP.PA.

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

Cited by 14 publications

References 14 publications

Comparison of Six Automated Treponema-Specific Antibody Assays

Comparison of Six Automated Treponema-Specific Antibody Assays

Analytical evaluation of nine serological assays for diagnosis of syphilis

Evaluation of different confirmatory algorithms using seven treponemal tests on Architect Syphilis TP-positive/RPR-negative sera

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