An immunofiltration device for the simultaneous detection of non-treponemal and treponemal antibodies in patients with syphilis

Castro, Arnold R.; Mody, Himanshu; Parab, Shraddha; Patel, Mauli; Kikkert, Susan E.; Park, M M; Ballard, Ronald C.

doi:10.1136/sti.2010.042937

Cited by 19 publications

(21 citation statements)

References 14 publications

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“…About 33% (11/33) of papers reported on conflicts of interest, with each having at least one conflict of interest. In four articles [16]–[18], the authors evaluated the diagnostic test they had manufactured themselves or contributed to its manufacturing. The role of conflict of interest as a predictor of diagnostic performance could not be explored.…”

Section: Resultsmentioning

confidence: 99%

Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis

et al. 2013

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BackgroundRapid and point-of-care (POC) tests for syphilis are an invaluable screening tool, yet inadequate evaluation of their diagnostic accuracy against best reference standards limits their widespread global uptake. To fill this gap, a systematic review and meta-analysis was conducted to evaluate the sensitivity and specificity of rapid and POC tests in blood and serum samples against Treponema pallidum (TP) specific reference standards.MethodsFive electronic databases (1980–2012) were searched, data was extracted from 33 articles, and Bayesian hierarchical models were fit.ResultsIn serum samples, against a TP specific reference standard point estimates with 95% credible intervals (CrI) for the sensitivities of popular tests were: i) Determine, 90.04% (80.45, 95.21), ii) SD Bioline, 87.06% (75.67, 94.50), iii) VisiTect, 85.13% (72.83, 92.57), and iv) Syphicheck, 74.48% (56.85, 88.44), while specificities were: i) Syphicheck, 99.14% (96.37, 100), ii) Visitect, 96.45% (91.92, 99.29), iii) SD Bioline, 95.85% (89.89, 99.53), and iv) Determine, 94.15% (89.26, 97.66). In whole blood samples, sensitivities were: i) Determine, 86.32% (77.26, 91.70), ii) SD Bioline, 84.50% (78.81, 92.61), iii) Syphicheck, 74.47% (63.94, 82.13), and iv) VisiTect, 74.26% (53.62, 83.68), while specificities were: i) Syphicheck, 99.58% (98.91, 99.96), ii) VisiTect, 99.43% (98.22, 99.98), iii) SD Bioline, 97.95%(92.54, 99.33), and iv) Determine, 95.85% (92.42, 97.74).ConclusionsRapid and POC treponemal tests reported sensitivity and specificity estimates comparable to laboratory-based treponemal tests. In resource limited settings, where access to screening is limited and where risk of patients lost to follow up is high, the introduction of these tests has already been shown to improve access to screening and treatment to prevent stillbirths and neonatal mortality due to congenital syphilis. Based on the evidence, it is concluded that rapid and POC tests are useful in resource limited settings with poor access to laboratories or screening for syphilis.

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Section: Resultsmentioning

confidence: 99%

Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis

et al. 2013

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“…Although syphilis can easily be diagnosed with traditional and modern tests (44)(45)(46) and effectively treated with penicillin (47), the continuing high global prevalence of this infection is a strong argument for the need to deepen our knowledge of syphilis pathogenesis. Such research efforts will allow syphilis investigators to understand what mechanisms make T. pallidum such a successful pathogen able to invade virtually every bodily organ, including the placenta, and persist for the lifetime of the infected host, in spite of a robust immune response (48).…”

Section: Discussionmentioning

confidence: 99%

Transcription of TP0126, Treponema pallidum Putative OmpW Homolog, Is Regulated by the Length of a Homopolymeric Guanosine Repeat

Giacani

Brandt

et al. 2015

Infect Immun

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An effective mechanism for introduction of phenotypic diversity within a bacterial population exploits changes in the length of repetitive DNA elements located within gene promoters. This phenomenon, known as phase variation, causes rapid activation or silencing of gene expression and fosters bacterial adaptation to new or changing environments. Phase variation often occurs in surface-exposed proteins, and in Treponema pallidum subsp. pallidum, the syphilis agent, it was reported to affect transcription of three putative outer membrane protein (OMP)-encoding genes. When the T. pallidum subsp. pallidum Nichols strain genome was initially annotated, the TP0126 open reading frame was predicted to include a poly(G) tract and did not appear to have a predicted signal sequence that might suggest the possibility of its being an OMP. Here we show that the initial annotation was incorrect, that this poly(G) is instead located within the TP0126 promoter, and that it varies in length in vivo during experimental syphilis. Additionally, we show that TP0126 transcription is affected by changes in the poly(G) length consistent with regulation by phase variation. In silico analysis of the TP0126 open reading frame based on the experimentally identified transcriptional start site shortens this hypothetical protein by 69 amino acids, reveals a predicted cleavable signal peptide, and suggests structural homology with the OmpW family of porins. Circular dichroism of recombinant TP0126 supports structural homology to OmpW. Together with the evidence that TP0126 is fully conserved among T. pallidum subspecies and strains, these data suggest an important role for TP0126 in T. pallidum biology and syphilis pathogenesis.

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“…Although a POC test that detects both treponemal and nontreponemal antibodies has been developed, the detector conjugate needed refrigeration. 7 The test used in the present study can be performed with whole blood; it was developed to simultaneously detect both treponemal and nontreponemal antibodies; the device is stable at room temperature and does not require refrigeration. This study demonstrated that the sensitivity and specificity of the test are as good as the standard diagnostic tests for syphilis.…”

Section: The Diagnosis Of Sexually Transmitted Infections Including mentioning

confidence: 99%

Evaluation of an Immunochromatographic Point-of-Care Test for the Simultaneous Detection of Nontreponemal and Treponemal Antibodies in Patients With Syphilis

Castro¹,

Lopes²,

Pereira³

2014

Sexually Transmitted Diseases

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We described the evaluation of the Syphilis Screening & Confirm Assay for the simultaneous detection of nontreponemal and treponemal antibodies. A total of 248 samples were evaluated. The sensitivity of the tests was 98.8%, 99.5% and 98.9%, while specificity was 94.7%, 88.9% and 93.2%, respectively, as compared with the rapid plasma reagin, Treponema pallidum hemagglutination assay, and fluorescent treponemal antibody absorption tests.

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An immunofiltration device for the simultaneous detection of non-treponemal and treponemal antibodies in patients with syphilis

Abstract: These results indicate that the dual treponemal and non-treponemal assay could be used as a screen and confirmatory test for the serological diagnosis of syphilis in remote or resource-poor settings where there is a need to provide counselling and treatment at the initial consultation.

Cited by 19 publications

References 14 publications

Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis

Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis

Transcription of TP0126, Treponema pallidum Putative OmpW Homolog, Is Regulated by the Length of a Homopolymeric Guanosine Repeat

Evaluation of an Immunochromatographic Point-of-Care Test for the Simultaneous Detection of Nontreponemal and Treponemal Antibodies in Patients With Syphilis

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