Evidence map›Paper›PMID 32517670›Full record

ArticleBMC pregnancy and childbirth2020

Development and analytical validation of real-time PCR for the detection of Streptococcus agalactiae in pregnant women.

Daniel F Escobar, Diego A Diaz-Dinamarca, Carlos F Hernández, Daniel A Soto, Ricardo A Manzo, Pedro I Alarcón, Camila H Pinto, Diego N Bastias, Carolayn N Oberg-Bravo, Robert Rojas and 3 more

Abstract read
In one paragraph

Article in BMC pregnancy and childbirth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

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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

13 authors.

Daniel F EscobarSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Diego A Diaz-DinamarcaSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Carlos F HernándezSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Daniel A SotoSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Ricardo A ManzoSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Pedro I AlarcónSección Bacteriología del Departamento Biomédico, Instituto de Salud Pública de Chile, Santiago, Chile.
Camila H PintoSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Diego N BastiasSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Carolayn N Oberg-BravoSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile.
Robert RojasCentro de Genómica y Bioinformática, Universidad Mayor, Santiago, Chile.
Sebastián E IllanesDepartment of Obstetrics and Gynecology, Faculty of Medicine, Universidad de los Andes, Santiago, Chile.
Alexis M KalergisMillennium Institute on Immunology and Immunotherapy, Departamento de Genética Molecular y Microbiología, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile.
Abel E VasquezSección de Biotecnología, Instituto de Salud Pública de Chile, Santiago, Chile. avasquez@ispch.cl.ORCID http://orcid.org/0000-0001-7346-9043

Funding

Fondo de Fomento al Desarrollo Científico y Tecnológico D10I1202Instituto de Salud publica de Chile isp-2019Millennium Institute of Immunology and Immunotherapy P09/016-F
6 · The paper itself

Abstract

backgroundGroup B Streptococcus (GBS) is the leading cause of invasive neonatal infection. In this study, we aimed to evaluate the analytical validation of qualitative real-time polymerase chain reaction (qPCR) as a means to detect GBS.

methodsGenomic DNA (gDNA) was purified from 12 ATCC bacterial strains, two belonging to GBS and the remainder acting as negative controls. Additionally, gDNA was isolated from 21 strains of GBS from various serotypes (Ia, Ib and II-VIII). All gDNA was used to evaluate the analytical validation of the qPCR method employing a specific Taqman probe. Inclusivity, exclusivity, anticipated reportable range, the limit of detection and robustness were evaluated. The methods used are described in international guidelines and other existing reports. The performance of this qPCR method for detecting GBS was compared to other microbiological methods used with vaginal-rectal samples from pregnant women.

resultsOur qPCR method for detecting GBS was analytically validated. It has a limit of detection of 0.7 GE/μL and 100% analytical specificity. It detects all strains of GBS with the same level of performance as microbiological methods.

conclusionData suggest that this qPCR method performs adequately as a means to detect GBS in vaginal-rectal swabs from pregnant women.

Indexed as

DNA, BacterialFemaleHumansPregnancyPregnancy Complications, InfectiousReal-Time Polymerase Chain ReactionRectumSensitivity and SpecificityStreptococcal InfectionsStreptococcus agalactiaeVaginaDNA, BacterialAnalytical validationBacterial detectionGroup B StreptococcusqPCRSurface immunogenic protein

Identifiers

PMID32517670
PMCPMC7285471

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LicenceCC BY
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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.