Evidence map›Paper›PMID 25385043›Full record

ArticleJournal of clinical laboratory analysis2015

Evaluation of a Rapid Immunochromatographic Treponemal Antibody Test Comparing the Treponema Pallidum Particle Agglutination Assay.

Jong-Han Lee, Chae Seung Lim, Min-Geol Lee, Hyon-Suk Kim

Open access · greenAbstract readComparative Study
In one paragraph

Article in Journal of clinical laboratory analysis, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.3field-weighted citation impact, top 39% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

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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

4 authors at 2 institutions in 1 country.

Jong-Han LeeDepartment of Laboratory Medicine, Korea University College of Medicine, Seoul, Korea.
Chae Seung LimDepartment of Laboratory Medicine, Korea University College of Medicine, Seoul, Korea.
Min-Geol LeeDepartment of Dermatology, Yonsei University College of Medicine, Seoul, Korea.
Hyon-Suk KimDepartment of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea.
Korea University · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn addition to conventional tests, several methods for detection of treponema-specific antibodies in clinical settings have been recently introduced. We aim to comparatively evaluate a rapid immunochromatographic test (ICT) for Treponema pallidum specific antibody (SD Bioline Syphilis 3.0) and the T. pallidum particle agglutination (TPPA) assay.

methodsIn all, 132 serum samples from 78 syphilis patients and 54 syphilis-negative controls were analyzed. SD Bioline Syphilis 3.0 test (Standard Diagnostic, Inc., Yongin, Korea) was evaluated and compared to Serodia TPPA assay (Fujirebio, Inc., Tokyo, Japan). All discrepant results between the two assays were repeatedly tested and evaluated by the fluorescent treponemal antibody-absorption (FTA-ABS) assay. Test reproducibility and 95% limit of detection of SD Bioline Syphilis 3.0 were determined across three different lots for seven consecutive days in triplicate. Interference due to autoantibodies and pregnancy was also tested.

resultsPercent agreement between SD Bioline Syphilis 3.0 and TPPA assays was 99.2%. Sensitivity and specificity were 100%, respectively. In TPPA assay, test-to-test, day-to-day, and lot-to-lot variations were not identified until 1:320 titer (eightfold dilutions). There was no interference due to the presence of antinuclear antibodies or samples or pregnancy.

conclusionsPercent agreement of SD Syphilis 3.0 and TPPA was very good. Sensitivity and specificity were appropriate for T. pallidum antibody detection. Thus, a rapid ICT could be suitable for syphilis antibody detection.

Indexed as

Antibodies, BacterialCase-Control StudiesChromatography, AffinityHumansLimit of DetectionMaleMiddle AgedReproducibility of ResultsSyphilisSyphilis SerodiagnosisTreponema pallidumAntibodies, Bacterialagreementrapid immunochromatographic testSyphilisTreponema pallidum particle agglutination (TPPA)

Identifiers

PMID25385043
PMCPMC6807139
OpenAlexW1928102697

What OpenQuestion holds

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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.