Validation of Reverse Sequence Screening for Syphilis

Lipinsky, Dafna; Schreiber, Licita; Kopel, Vered; Shainberg, Bracha

doi:10.1128/jcm.06286-11

Cited by 28 publications

(22 citation statements)

References 2 publications

(2 reference statements)

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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: Discussioncontrasting

confidence: 52%

“…Among CLIA-positive results, samples with a negative nontreponemal test present the major diagnostic challenge, as the test result can be caused by (i) previous syphilis infection with persistence of treponemal antibodies but seroreversion of nontreponemal antibodies, (ii) early primary syphilis in a person who has yet to develop non-treponemal antibodies, or (iii) a false-positive treponemal test result. Although the Architect Syphilis TP assay has a very high sensitivity, which even allows the detection of early primary syphilis, the assay is somewhat less specific and, therefore, prone to produce false-positive results, especially in borderline positive samples with results close to the cut-off [5,7,8]. In accordance with the International Union against Sexually Transmitted Infections (IUSTI) 2014 European guidelines, all positive screening tests need confirmation testing using another treponemal test of a different type [e.g., Treponema pallidum particle agglutination (TP.PA) or Treponema pallidum hemagglutination assay if CLIA is used for screening] [9].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussioncontrasting

confidence: 52%

Section: Introductionmentioning

confidence: 99%

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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“…However, in high-risk populations, screening with a TT can result in a high rate of positive results due to previously treated infections, leading to increased clinician workload needed to review cases and determine appropriate management. Some guidelines recommend further evaluation of reactive TT with a quantitative NTT and, if results of the latter are nonreactive, a second (different) TT to help resolve the discordant results 143,247,248 . The European Centre for Disease Prevention and Control uses a variation of this approach: a reactive TT immunoassay is followed by a second (different) TT of any kind (that is, not followed by an NTT) 249 .…”

Section: Figurementioning

confidence: 99%

Syphilis

Peeling

Mabey

Kamb

et al. 2017

Nat Rev Dis Primers

484

387

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Treponema pallidum subspecies pallidum (T. pallidum) causes syphilis via sexual exposure or vertical transmission during pregnancy. T. pallidum is renowned for its invasiveness and immune-evasiveness; its clinical manifestations result from local inflammatory responses to replicating spirochetes and often imitate those of other diseases. The spirochete has a long latent period during which patients have no signs or symptoms, but can remain infectious. Despite the availability of simple diagnostic tests and the effectiveness of treatment with a single dose of long-acting penicillin, syphilis is re-emerging as a global public health problem, particularly among men who have sex with men (MSM) in high-income and middle-income countries. Syphilis also causes several hundred thousand stillbirths and neonatal deaths every year in developing nations. Although several low-income countries have achieved WHO targets for the elimination of congenital syphilis, an alarming increase of syphilis in HIV-infected MSM serves as a strong reminder of the tenacity of T. pallidum as a pathogen. Strong advocacy and community involvement is needed to ensure that syphilis is given high priority on the global health agenda. More investment in research is needed on the interaction between HIV and syphilis in MSM, as well as into improved diagnostics, a better test of cure, intensified public health measures and, ultimately, a vaccine.

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“…13, 14 However, current literature has demonstrated that the reverse algorithm can be both highly specific and sensitive, with sensitivities surpassing that of the traditional algorithm. [15][16][17] The reverse algorithm is effective in detecting an initial syphilis infection, but because treponemal antibodies typically remain positive for life, immunologic assessment of reinfection is challenging.…”

mentioning

confidence: 99%

Prevalence of Traditional and Reverse-Algorithm Syphilis Screening in Laboratory Practice: A Survey of Participants in the College of American Pathologists Syphilis Serology Proficiency Testing Program

Rhoads

Genzen

Bashleben

et al. 2016

Archives of Pathology &Amp; Laboratory Medicine

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Context.—Syphilis serology screening in laboratory practice is evolving. Traditionally, the syphilis screening algorithm begins with a nontreponemal immunoassay, which is manually performed by a laboratory technologist. In contrast, the reverse algorithm begins with a treponemal immunoassay, which can be automated. The Centers for Disease Control and Prevention has recognized both approaches, but little is known about the current state of laboratory practice, which could impact test utilization and interpretation. Objective.—To assess the current state of laboratory practice for syphilis serologic screening. Design.—In August 2015, a voluntary questionnaire was sent to the 2360 laboratories that subscribe to the College of American Pathologists syphilis serology proficiency survey. Results.—Of the laboratories surveyed, 98% (2316 of 2360) returned the questionnaire, and about 83% (1911 of 2316) responded to at least some questions. Twenty-eight percent (378 of 1364) reported revision of their syphilis screening algorithm within the past 2 years, and 9% (170 of 1905) of laboratories anticipated changing their screening algorithm in the coming year. Sixty-three percent (1205 of 1911) reported using the traditional algorithm, 16% (304 of 1911) reported using the reverse algorithm, and 2.5% (47 of 1911) reported using both algorithms, whereas 9% (169 of 1911) reported not performing a reflex confirmation test. Of those performing the reverse algorithm, 74% (282 of 380) implemented a new testing platform when introducing the new algorithm. Conclusion.—The majority of laboratories still perform the traditional algorithm, but a significant minority have implemented the reverse-screening algorithm. Although the nontreponemal immunologic response typically wanes after cure and becomes undetectable, treponemal immunoassays typically remain positive for life, and it is important for laboratorians and clinicians to consider these assay differences when implementing, using, and interpreting serologic syphilis screening algorithms.

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Validation of Reverse Sequence Screening for Syphilis

Cited by 28 publications

References 2 publications

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

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

Syphilis

Prevalence of Traditional and Reverse-Algorithm Syphilis Screening in Laboratory Practice: A Survey of Participants in the College of American Pathologists Syphilis Serology Proficiency Testing Program

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