Evidence map›Paper›PMID 19131273›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2009

Serologic detection of herpes simplex virus type 2 antibodies among pregnant women using a point-of-care test from Focus Diagnostics.

Bridget Leyland, Margaret R Kennedy, Yolanda H Wimberly, Bruce J Levine, Thomas L Cherpes

Abstract readComparative StudyEvaluation Study
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2009. 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
–field-weighted citation impact
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.

  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.

Bridget LeylandMagee-Womens Research Institute, Pittsburgh, PA 15213, USA.
Margaret R Kennedy
Yolanda H Wimberly
Bruce J Levine
Thomas L Cherpes

Funding

HSV-2 shedding: role of hormonal contraception and BVK23AI064396 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CHERPES, THOMAS L. · 2005 to 2009
$633k
NIAID NIH HHS K23 AI064396
6 · The paper itself

Abstract

backgroundSerologic assays that identify herpes simplex type 2 (HSV-2) type-specific antibodies have been commercially available for more than a decade. Greater acceptance of these tests is hindered by uncertainty regarding their performance in real-world clinical settings.

objectivesThe primary objective was to compare the test characteristics of the Focus HerpeSelect Express Assay (EA) versus the Focus HerpeSelect enzyme linked immunoassay (ELISA) for detection of HSV-2 type-specific antibodies among pregnant women enrolled from 3 geographic sites with varying prevalences of HSV-2 infection. A second objective was to evaluate the performance of a HSV-2 testing strategy in which EA screens and ELISA confirms HSV-2 serodiagnosis. STUDY

designWe enrolled 399 pregnant women from Atlanta, GA, Moorestown, NJ, and Pittsburgh, PA into this cross-sectional investigation. Capillary whole blood was obtained from study participants, and evaluated for the presence of type-specific HSV-2 antibodies using the EA. Serum samples were also obtained from all study participants for subsequent identification of HSV-2 type-specific antibodies using both ELISA and the Focus Immunoblot assays.

resultsWe observed 96.2% agreement between results obtained with EA and ELISA. Overall, when compared to ELISA results, the sensitivity of EA for detection of HSV-2 type-specific antibodies was 94.2% and the specificity was 97.1%. Using Immunoblot results as our standard for performance calculations, the positive predictive value (PPV) of HSV-2 serodiagnosis increased from 91.7% to 98.2% when ELISA was used to confirm EA testing.

conclusionsEA provides similar results to ELISA for the identification of HSV-2 type-specific antibodies among pregnant women. As use of the point-of-care (POC) EA in conjunction with confirmatory ELISA testing improves the PPV of HSV-2 serodiagnosis compared to the use of EA or ELISA testing alone, validation of this diagnostic algorithm in other at-risk populations may be warranted.

Indexed as

Point-of-Care SystemsAdolescentAdultAntibodies, ViralFemaleGeorgiaHerpes GenitalisHerpesvirus 2, HumanHumansMiddle AgedNew JerseyPennsylvaniaPredictive Value of TestsPregnancyPregnancy Complications, InfectiousSensitivity and SpecificityAntibodies, Viral

Identifiers

PMID19131273
PMCPMC2716794

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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.