Evidence map›Paper›PMID 27358468›Full record

ArticleJournal of clinical microbiology2016

Evaluation of Elecsys Syphilis Assay for Routine and Blood Screening and Detection of Early Infection.

J Kremastinou, V Polymerou, D Lavranos, A Aranda Arrufat, J Harwood, M J Martínez Lorenzo, K P Ng, L Queiros, I Vereb, M Cusini

Open access · hybridAbstract readEvaluation StudyMulticenter Study
In one paragraph

Article in Journal of clinical microbiology, 2016. 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
1.2field-weighted citation impact, top 21% 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, 9 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

10 authors at 5 institutions in 5 countries.

J KremastinouBiomedicine SA, Athens, Greece.
V PolymerouBiomedicine SA, Athens, Greece.
D LavranosBiomedicine SA, Athens, Greece.
A Aranda ArrufatBanco de Sangre y Tejidos de Aragon, Zaragoza, Spain.
J HarwoodFreeman Hospital, Newcastle, United Kingdom.
M J Martínez LorenzoBanco de Sangre y Tejidos de Aragon, Zaragoza, Spain.
K P NgUniversity of Malaya Medical Center, Kuala Lumpur, Malaysia.
L QueirosBlood and Transplantation Center, Porto, Portugal.
I VerebRegional Hospital, Gävle, Sweden.
M CusiniFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy m.cusini@policlinico.mi.it.
Banc de Sang i Teixits · ESFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITFreeman Hospital · GBGävle Hospital · SEUniversity Malaya Medical Centre · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treponema pallidum infections can have severe complications if not diagnosed and treated at an early stage. Screening and diagnosis of syphilis require assays with high specificity and sensitivity. The Elecsys Syphilis assay is an automated treponemal immunoassay for the detection of antibodies against T. pallidum The performance of this assay was investigated previously in a multicenter study. The current study expands on that evaluation in a variety of diagnostic settings and patient populations, at seven independent laboratories. The samples included routine diagnostic samples, blood donation samples, samples from patients with confirmed HIV infections, samples from living organ or bone marrow donors, and banked samples, including samples previously confirmed as syphilis positive. This study also investigated the seroconversion sensitivity of the assay. With a total of 1,965 syphilis-negative routine diagnostic samples and 5,792 syphilis-negative samples collected from blood donations, the Elecsys Syphilis assay had specificity values of 99.85% and 99.86%, respectively. With 333 samples previously identified as syphilis positive, the sensitivity was 100% regardless of disease stage. The assay also showed 100% sensitivity and specificity with samples from 69 patients coinfected with HIV. The Elecsys Syphilis assay detected infection in the same bleed or earlier, compared with comparator assays, in a set of sequential samples from a patient with primary syphilis. In archived serial blood samples collected from 14 patients with direct diagnoses of primary syphilis, the Elecsys Syphilis assay detected T. pallidum antibodies for 3 patients for whom antibodies were not detected with the Architect Syphilis TP assay, indicating a trend for earlier detection of infection, which may have the potential to shorten the time between infection and reactive screening test results.

Indexed as

Antibodies, BacterialAutomation, LaboratoryEarly DiagnosisHumansImmunoassayMass ScreeningSensitivity and SpecificitySyphilisTreponema pallidumAntibodies, Bacterial

Identifiers

PMID27358468
PMCPMC5005501
OpenAlexW2461807522

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Registered trials

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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.