Laboratory diagnosis of syphilis with automated immunoassays

Marangoni, Antonella; Moroni, Alessandra; Accardo, Silvia; Cevenini, Roberto

doi:10.1002/jcla.20268

Cited by 46 publications

(32 citation statements)

References 31 publications

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“…Of 334 patients who had reactive CMIA results and nonreactive RPR results, 197 (59%) had reactive TP-PA results ( Table 1). The high percentage of false positives obtained by the CMIA was shown in previous studies (3,4). False-positive results were also obtained in the RPR test.…”

supporting

confidence: 58%

Validation of Reverse Sequence Screening for Syphilis

et al. 2012

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supporting

confidence: 58%

Validation of Reverse Sequence Screening for Syphilis

et al. 2012

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“…In particular, it is noteworthy that 37 of these samples were from healthy blood donors, already evaluated in a previous study (11), and 12 samples were from healthy pregnant women, whereas the remaining 51 were from elderly patients (over 75 years of age) hospitalized for different disorders. Taking into account that consecutive samples drawn from the same patients, in the absence of therapy, gave positive results only by CMIA and not by other tests, it follows that CMIA reactivity was consistent with two different hypotheses: false-positive results or syphilis infections in the remote past in previously treated elderly patients.…”

Section: Methodsmentioning

confidence: 99%

“…However, since positivity with respect to treponemal tests lasts a lifetime, they cannot be useful in followup. Treponemal tests include the serum fluorescent treponemal antibody absorption test (FTA-ABS), T. pallidum hemagglutination (TPHA) test, enzyme immunoassay (EIA), and Western blot (WB) assay; both EIA and WB tests can be based on either wholecell lysate (7)(8)(9)(10)(11) or recombinant (12)(13)(14)(15)(16) treponemal antigens. Recently, chemiluminescent immunoassays set up with recombinant antigens have been evaluated (17,18).…”

mentioning

confidence: 99%

Evaluation of the BioPlex 2200 Syphilis System as a First-Line Method of Reverse-Sequence Screening for Syphilis Diagnosis

Marangoni

Nardini

Foschi

et al. 2013

Clin. Vaccine Immunol.

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Despite recent technological advances, the diagnosis of syphilis remains a challenging enterprise. Actually, most high-volume laboratories have adopted the "reverse algorithm" due several factors, including the potential to automate testing. Recently, immunoassays processed on random-access systems have been proposed as screening tests. The purpose of this study was to evaluate diagnostic performances of BioPlex 2200 Syphilis IgG and BioPlex 2200 Syphilis IgM, tests based on Multiplex Flow technology, in comparison with the performance of Architect Syphilis TP, a chemiluminescent immunoassay for the detection of IgG and/or IgM anti-Treponema pallidum antibodies. A retrospective study was performed with a panel of 100 blood donor sera, a panel of 350 clinical and laboratory-characterized syphilitic sera, and 170 samples obtained from subjects with potentially interfering conditions. Moreover, 200 unselected samples submitted to the Microbiology Laboratory of St. Orsola Hospital in Bologna for routine screening for syphilis were evaluated. As confirmatory tests, T. pallidum hemagglutination and Western blot assays were used. Considering the IgG Western blot (WB) assay to be the gold standard method, BioPlex 2200 Syphilis IgG specificity was far higher than Architect Syphilis TP specificity (89.7% versus 78.4%, respectively), whereas the sensitivity was 100% for both automated methods. Compared to the IgM WB assay, BioPlex 2200 Syphilis IgM performed with a specificity of 94.9%, whereas the sensitivity was 84.8%. Considering the excellent ease of use and automation, the high sample throughput and its valuable analytical performances, BioPlex Syphilis 2200 IgG could represent a suitable choice for high-volume laboratories. BioPlex Syphilis 2200 IgM could be considered a good addition to IgG testing for uncovering active infections.

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“…At this threshold two samples out of 53 were WB indeterminate with single TpN17 reactivity, yet they were TPHA positive. It is tempting to speculate that these samples are truepositives since TpN17 has been reported to be highly specific, and causing antibody responses at all stages of infection (8,10,16). The results of this study also showed clustering of the s/co ratios of the TpN17-only positive samples in close proximity to true-positives.…”

Section: Discussionmentioning

confidence: 53%

Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay

Akçakanat

Özbek

Doğan

et al. 2018

J Basic Clin Health Sci

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Purpose: The use of Architect Syphilis TP (CMIA) in the blood bank raised the number of syphilis positive samples requiring confirmation. The aim of this study is to determine a sample-to-cutoff (s/co) ratio for CMIA predicting ≥95% of true-positive samples to reduce these samples.Methods: CMIA reactive samples (n=177) were evaluated by Western blot (WB) as the reference standard, as well as by Treponema pallidum hemagglutination (TPHA) and Rapid Plasma Reagin (RPR) tests. The s/co ratio predicting ≥95% of true-positive samples was defined as the threshold leaving ≥95% of WB confirmed samples greater than the particular value. The performances of TPHA and RPR tests were also evaluated with respect to s/co ratios of CMIA positive samples. Results:The s/co ratio 15.17 predicted a true-positive result for ≥95% of samples tested (95% confidence interval: 85.9-99.3) and reduced the number of samples requiring confirmation by 29.9%. Higher s/co ratios were correlated with the increasing number of bands on WB strips (p<0.0001, R=0.906). For the samples with s/co ratios between 3 and 15.17, the agreement of TPHA and WB test results were 90%. The lowest s/co ratio where TPHA was positive, was 3.1. Although RPR predicted >95% of positive samples with s/co ratios ≥15, its sensitivity was 47.7%. Conclusion:Higher s/co ratios can be used to define true-positivity and may indicate an active infection. TPHA may replace WB to confirm samples with s/co ratios between 3 and 15. RPR should not be used as a screening test in blood banks as it could miss almost half of the truepositive samples.

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Laboratory diagnosis of syphilis with automated immunoassays

Cited by 46 publications

References 31 publications

Validation of Reverse Sequence Screening for Syphilis

Validation of Reverse Sequence Screening for Syphilis

Evaluation of the BioPlex 2200 Syphilis System as a First-Line Method of Reverse-Sequence Screening for Syphilis Diagnosis

Determination of a Sample-to-Cutoff Ratio to Predict True-Positivity in Blood Donor Samples Screened for Syphilis by a Chemiluminescent Immunoassay

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