Evidence map›Paper›PMID 32376729›Full record

ArticleSexually transmitted infections2020

Development of a novel magnetic particle-based agglutination immunoassay for anticardiolipin antibody detection in syphilis.

Mayur R Shukla, John W Deutsch, Lara E Pereira, Ellen N Kersh, Yetunde F Fakile

Open access · bronzeAbstract read
In one paragraph

Article in Sexually transmitted infections, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Mayur R ShuklaDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA iun9@cdc.gov.ORCID 0000-0003-4378-6288
John W DeutschOak Ridge Institute for Science and Education, Oak Ridge, Tennessee, USA.
Lara E PereiraDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Ellen N KershDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Yetunde F FakileDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Centers for Disease Control and Prevention · USOak Ridge Associated Universities · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesSerological tests of non-treponemal and treponemal types are the most frequently used for syphilis diagnosis. Treponemal tests are available in wide variety of assay formats; however, limited advances have been made for the improvement of conventional non-treponemal tests. The objective of this work was to develop a novel non-treponemal magnetic particle-based agglutination assay (NT-MAA) and evaluate its feasibility for syphilis testing.

methodsCardiolipin was modified and coupled to magnetic microbeads. Serum diluted in phosphate-buffered saline was mixed with cardiolipin-coupled beads and incubated in a round bottom microplate for 90-120 min followed by visual inspection. A panel of reported syphilis (n=127) and non-reactive (n=244) specimens was prepared to evaluate the NT-MAA performance in comparison to conventional rapid plasma reagin (RPR).

resultsThe non-treponemal NT-MAA and RPR showed sensitivity of 90.6% and 88.2% and specificity of 96.7% and 100%, respectively. The treponemal TP-PA and EIA yielded sensitivity of 100% and 99.2%, respectively, and 100% specificity by both assays. The per cent agreement between NT-MAA and RPR was 97% (kappa=0.931, 95% CI 0.891 to 0.971). Analytical sensitivity determined with IgM anticardiolipin antibody (ACA) was 2.6 µg/mL for both NT-MAA and RPR, while IgG ACA yielded 0.9 µg/mL and 1.7 µg/mL for NT-MAA and RPR, respectively. Qualitative results of intra-assay and interassay reproducibility revealed 100% consistency for NT-MAA.

conclusionPreliminary evaluation of the novel NT-MAA validated proof of concept using laboratory-characterised syphilis sera and demonstrated performance comparable to RPR. Further validation of NT-MAA using additional specimens with better clinical staging may broaden the scope of developed test for syphilis diagnosis.

Indexed as

Agglutination TestsAntibodies, AnticardiolipinCase-Control StudiesChromatography, AffinityFeasibility StudiesHumansImmunoassayImmunoglobulin GImmunoglobulin MMagnetsSensitivity and SpecificitySyphilisAntibodies, AnticardiolipinImmunoglobulin GImmunoglobulin Mantibodiesdiagnosticsimmunologysyphilistesting

Identifiers

PMID32376729
PMCPMC7476289
OpenAlexW3022805908

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.