Evidence map›Paper›PMID 26818677›Full record

ArticleJournal of clinical microbiology2016

Development and Validation of a Highly Accurate Quantitative Real-Time PCR Assay for Diagnosis of Bacterial Vaginosis.

David W Hilbert, William L Smith, Sean G Chadwick, Geoffrey Toner, Eli Mordechai, Martin E Adelson, Tina J Aguin, Jack D Sobel, Scott E Gygax

Erratum issuedOpen access · bronzeAbstract readEvaluation 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. An erratum has been issued. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
8.4field-weighted citation impact, top 2% 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

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

  1. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  2. Trial
  3. Trial
  4. Probiotics in addition to metronidazole for treatment Trichomonas vaginalis in the presence of BV: a randomized, placebo-controlled, double-blind study.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Prevalence and clinical correlates ofFrontiers in cellular and infection microbiology · 2024
    Article
  11. Article
  12. Molecular Testing for the Diagnosis of Bacterial Vaginosis.International journal of molecular sciences · 2023
    Review
  13. State of the Art for Diagnosis of Bacterial Vaginosis.Journal of clinical microbiology · 2023
    Review
  14. Article
  15. Bacterial Vaginosis and Post-Operative Pelvic Infections.Healthcare (Basel, Switzerland) · 2023
    Review
  16. Article
  17. Observational
  18. Article
  19. Log (Bioengineered · 2022
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

David W HilbertFemeris Women's Health Research Center, Medical Diagnostic Laboratories, a member of Genesis Biotechnology group, Hamilton, New Jersey, USA dhilbert@femeris.com sgygax@femeris.com.
William L SmithFemeris Women's Health Research Center, Medical Diagnostic Laboratories, a member of Genesis Biotechnology group, Hamilton, New Jersey, USA.
Sean G ChadwickFemeris Women's Health Research Center, Medical Diagnostic Laboratories, a member of Genesis Biotechnology group, Hamilton, New Jersey, USA.
Geoffrey TonerFemeris Women's Health Research Center, Medical Diagnostic Laboratories, a member of Genesis Biotechnology group, Hamilton, New Jersey, USA.
Eli MordechaiFemeris Women's Health Research Center, Medical Diagnostic Laboratories, a member of Genesis Biotechnology group, Hamilton, New Jersey, USA.
Martin E AdelsonFemeris Women's Health Research Center, Medical Diagnostic Laboratories, a member of Genesis Biotechnology group, Hamilton, New Jersey, USA.
Tina J AguinDepartment of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan, USA.
Jack D SobelDivision of Infectious Diseases, Wayne State University School of Medicine, Detroit, Michigan, USA.
Scott E GygaxFemeris Women's Health Research Center, Medical Diagnostic Laboratories, a member of Genesis Biotechnology group, Hamilton, New Jersey, USA dhilbert@femeris.com sgygax@femeris.com.
Wayne State University · USMedical Diagnostic Laboratories (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bacterial vaginosis (BV) is the most common gynecological infection in the United States. Diagnosis based on Amsel's criteria can be challenging and can be aided by laboratory-based testing. A standard method for diagnosis in research studies is enumeration of bacterial morphotypes of a Gram-stained vaginal smear (i.e., Nugent scoring). However, this technique is subjective, requires specialized training, and is not widely available. Therefore, a highly accurate molecular assay for the diagnosis of BV would be of great utility. We analyzed 385 vaginal specimens collected prospectively from subjects who were evaluated for BV by clinical signs and Nugent scoring. We analyzed quantitative real-time PCR (qPCR) assays on DNA extracted from these specimens to quantify nine organisms associated with vaginal health or disease:Gardnerella vaginalis,Atopobium vaginae, BV-associated bacteria 2 (BVAB2, an uncultured member of the orderClostridiales),Megasphaeraphylotype 1 or 2,Lactobacillus iners,Lactobacillus crispatus,Lactobacillus gasseri, andLactobacillus jensenii We generated a logistic regression model that identifiedG. vaginalis,A. vaginae, andMegasphaeraphylotypes 1 and 2 as the organisms for which quantification provided the most accurate diagnosis of symptomatic BV, as defined by Amsel's criteria and Nugent scoring, with 92% sensitivity, 95% specificity, 94% positive predictive value, and 94% negative predictive value. The inclusion ofLactobacillusspp. did not contribute sufficiently to the quantitative model for symptomatic BV detection. This molecular assay is a highly accurate laboratory tool to assist in the diagnosis of symptomatic BV.

Indexed as

AdolescentAdultAnimalsFemaleHumansLongitudinal StudiesMicrobiological TechniquesMiddle AgedMolecular Diagnostic TechniquesReal-Time Polymerase Chain ReactionSensitivity and SpecificityUnited StatesVaginosis, BacterialYoung Adult

Identifiers

PMID26818677
PMCPMC4809904
OpenAlexW2288499863

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.