Evaluation of LIAISON Treponema Screen, a Novel Recombinant Antigen-Based Chemiluminescence Immunoassay for Laboratory Diagnosis of Syphilis

Marangoni, Antonella; Sambri, Vittorio; Accardo, Silvia; Cavrini, Francesca; D’Antuono, Antonietta; Moroni, Alessandra; Storni, Elisa; Cevenini, Roberto

doi:10.1128/cdli.12.10.1231-1234.2005

Cited by 64 publications

(50 citation statements)

References 19 publications

(17 reference statements)

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“…Several different immunoassays set up with whole-cell lysate (12)(13)(14)(15) or recombinant T. pallidum antigens (16)(17)(18)(19)(20)(21)(22) are described in the literature.…”

Section: Discussionmentioning

confidence: 99%

“…Treponemal tests include the serum fluorescent treponemal antibody absorption test, the T. pallidum hemagglutination test (TPHA) (Radim, Pomezia, Italy), the enzyme-linked immunoassay (ELISA), and the Western Blot (WB) assay; both ELISA and WB tests can be based on either whole-cell lysate (12)(13)(14)(15) or recombinant (16)(17)(18)(19)(20) treponemal antigens. More recently, chemiluminescent immunoassays set up with recombinant antigens have been evaluated (21,22). The purpose of this study was to evaluate the diagnostic performances of Enzygnost Syphilis (Dade Behring, Marburg, Germany) in comparison with ARCHITECT Syphilis TP (Abbott Japan Co., Tokyo, Japan).…”

Section: Introductionmentioning

confidence: 99%

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Laboratory diagnosis of syphilis with automated immunoassays

Marangoni

Moroni

Accardo

et al. 2009

Clinical Laboratory Analysis

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The serological detection of specific antibodies to Treponema pallidum is of particular importance in the diagnosis of syphilis. The purpose of this study was to evaluate diagnostic performances of automated immunoassays in comparison with T. pallidum hemagglutination test (TPHA) and Western Blot (WB). The retrospective study was performed with different panels of sera: 244 clinical and serological characterized syphilitic sera and 203 potentially interfering samples. All the sera were tested by Enzygnost Syphilis, ARCHITECT Syphilis TP, TPHA, and homemade WB.The diagnostic performances of the two assays were very similar: both Enzygnost Syphilis and ARCHITECT Syphilis TP performed with a sensitivity of 99.2%, whereas the specificity was 98.5 and 98.4%, respectively. Considering the suitability for automation, both immunoassays may represent a good choice as a screening test. However, the use of a confirmatory test, such as TPHA or WB, remains a must in order to avoid false-positive results.

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“…Several different immunoassays set up with whole-cell lysate (12)(13)(14)(15) or recombinant T. pallidum antigens (16)(17)(18)(19)(20)(21)(22) are described in the literature.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Laboratory diagnosis of syphilis with automated immunoassays

Marangoni

Moroni

Accardo

et al. 2009

Clinical Laboratory Analysis

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“…Specificity was 99.9% for all treponemal tests. From 96 sera obtained from patient suffering from potentially cross-reactive conditions, no serum gave a positive result by LIAISON (Marangoni et al, 2005). However, another study for evaluation of LIAISON test found lower sensitivity of 94.1% (48/51), in primary and secondary syphilis (Knight et al, 2007).…”

Section: Immunochemoluminescence Assay (Cia) and Multiplex Flow Immunmentioning

confidence: 99%

Laboratorial Diagnosis of Syphilis

Sato¹

2011

Syphilis - Recognition, Description and Diagnosis

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“…The sensitivities of these commercial assays ranged from 23 to 77%, compared to 44% for VDRL (15). Marangoni et al reported CLIA and EIA sensitivities of 100 and 57%, respectively, for primary syphilis (11). With regard to secondary, latent, and late syphilis, most studies show superior sensitivity of treponemal immunoassays over nontreponemal assays.…”

mentioning

confidence: 99%

“…Among primary cases, the sensitivities of nine EIAs ranged from 93 to 98%, while the sensitivity of one kit was 88%. Marangoni et al evaluated the performance of commercial CLIA and EIA kits (11). Among 54 cases of untreated syphilis, the sensitivities of CLIA, EIA, and RPR were 100, 94, and 96%, respectively.…”

mentioning

confidence: 99%

Point-Counterpoint: It Is Time To Use Treponema-Specific Antibody Screening Tests for Diagnosis of Syphilis

Loeffelholz

Binnicker

2012

J Clin Microbiol

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Assays that detect treponema-specific antibodies, which are either automated or can be done as point-of-care tests, have been developed, some of which are FDA approved. These assays have the advantage of being easily performed and demonstrate high sensitivity, both key features of an infectious disease screening test. As a result, many high-volume clinical laboratories have begun to offer a reverse syphilis testing algorithm where a treponema-specific test is used for screening, followed by a nontreponemal test (i.e., rapid plasma reagin [RPR]) to assess disease activity and treatment status. Concerns about physicians being able to understand and apply this new testing algorithm have been expressed (8). In this point-counterpoint, Michael Loeffelholz of the University of Texas Medical Branch at Galveston explains why his laboratory has adopted this reverse algorithmic approach. Matthew Binnicker of the Mayo Clinic, Rochester, MN, explains why the reverse algorithm may not be suitable for all clinical laboratories and every clinical situation. POINT Several expert committees and organizations now either recommend or include the option for the use of treponemaspecific assays to screen for syphilis. In this approach, a reactive treponemal screening assay is followed by a quantitative nontreponemal assay to diagnose active disease and to monitor response to treatment (i.e., the "reverse algorithm"). This algorithm also consists of a second and different treponemal assay that is used either to confirm all reactive screening results or only to resolve discordant screening and nontreponemal assay results (Fig. 1). The Association of Public Health Laboratories (http://www .aphl.org/aphlprograms/infectious/std/Documents/Laboratory GuidelinesTreponemapallidumMeetingReport.pdf, last accessed 11 September 2011), the United Kingdom Health Protection Agency (6), and the International Union Against Sexually Transmitted Infections (7) all endorse or encourage the use of a reverse algorithm that begins with a treponemal immunoassay. The United States Centers for Disease Control and Prevention (CDC) continues to recommend the traditional algorithm (3). However, in that report, the CDC acknowledges the use of treponemal immunoassays as screening assays and provides recommendations for laboratories that choose this reverse algorithm approach.The traditional approach to the diagnosis of syphilis begins with a nontreponemal assay, either the venereal disease research laboratory (VDRL) test or, more commonly, the RPR test that detect anticardiolipin antibodies (Fig. 1). Since these antibodies are not specific for syphilis, reactive nontreponemal assay results must be confirmed with an assay that detects antibodies produced against T. pallidum. Traditional treponemal assays used in this algorithm are fluorescent treponemal antibody absorption (FTA-ABS), microhemagglutination for T. pallidum, T. pallidum hemagglutination (TPHA), and TPPA. In 1975, Veldkamp and Visser described for the first time the use of a laboratory-developed enzyme ...

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Evaluation of LIAISON Treponema Screen, a Novel Recombinant Antigen-Based Chemiluminescence Immunoassay for Laboratory Diagnosis of Syphilis

Cited by 64 publications

References 19 publications

Laboratory diagnosis of syphilis with automated immunoassays

Laboratory diagnosis of syphilis with automated immunoassays

Laboratorial Diagnosis of Syphilis

Point-Counterpoint: It Is Time To Use Treponema-Specific Antibody Screening Tests for Diagnosis of Syphilis

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