Rapid Point-of-care Testing to Inform Intrapartum Treatment of Group B <i>Streptococcus</i>–Colonized Women in Uganda

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Abstract

Introduction

Maternal Group B Streptococcus (GBS) rectovaginal colonization is an important risk factor for invasive disease in neonates, yet availability of culture-based methods for detection is limited in low-resource settings. We evaluated the diagnostic performance of the HiberGene (HG) GBS loop-mediated isothermal amplification (LAMP) assay for the rapid detection of GBS in rectal/vaginal swabs collected from women in Uganda. This work forms a part of the PROGRESS GBS study.

Methods

In phase 1, 1294 rectal and vaginal swabs were collected from pregnant women and inoculated in enrichment (Lim) broth, which was then tested using the HG GBS LAMP assay ( sip gene target) and culture on chromogenic agar. In phase 2, 166 swabs from nonpregnant women were tested directly (without the enrichment step). For samples with discordant results, an additional method of testing against multiplex real-time polymerase chain reaction assay was used.

Results

Overall, the HG GBS LAMP assay detected more GBS-positive samples (31.3%; 452/1445) than culture-based methods (13.3%; 192/1445). Multiplex polymerase chain reaction–tested results were concordant with LAMP results in 96.3% of cases. The sensitivity and specificity of the LAMP assay, after adjusting for the tiebreaker results of discordant samples, were 94.4% (95% confidence interval, 86.2–99.4) and 99.0% (95% confidence interval, 94.3–100), respectively.

Conclusions

The results of this study demonstrate high sensitivity and specificity of the HG GBS LAMP assay for the detection of GBS rectovaginal colonization in our setting. Given its rapid turnaround time, the HG GBS LAMP assay could appropriately be used to screen women for GBS rectovaginal colonization during labor to enable provision of intrapartum antibiotic prophylaxis.

Abstract

The HiberGene Group B Streptococcus loop-mediated isothermal amplification assay demonstrates high sensitivity and specificity for detection of Group B Streptococcus rectovaginal colonization with rapid turnaround time, suggesting its use during labor to enable provision of intrapartum antibiotic prophylaxis in low-resource settings.

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Most cited references 22

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Advanced cervical dilatation as a predictor for low emergency cesarean delivery: a comparison between migrant and non-migrant Primiparae – secondary analysis in Berlin, Germany

Jürgen Breckenkamp, Eileen Marie Läcke, Wolfgang Henrich … (2019)

Background Cesarean rates are higher in women admitted to labor ward during early stages rather than at later stages of labor. In a study in Germany, crude cesarean rates among Turkish and Lebanese immigrant women were low compared to non-immigrant women. We evaluated whether these immigrant women were admitted during later stages of labor, and if so, whether this explains their lower cesarean rates. Methods We enrolled 1413 nulliparous women with vertex pregnancies, singleton birth, and 37+ week of gestation, excluding elective cesarean deliveries, in three Berlin obstetric hospitals. We applied binary logistic regression to adjust for social and obstetric factors; and standardized coefficients to rank predictors derived from the regression model. Results At the time of admission to labor ward, a smaller proportion of Turkish migrant women was in the active phase of labor (cervical dilation: 4+ cm), compared to women of Lebanese origin and non-immigrant women. Rates of cesarean deliveries were lower in women of Turkish and Lebanese origin (15.8 and 13.9%) than in non-immigrant women (23.9%). In the logistic regression analysis, more advanced cervical dilatation was inversely associated with the outcome cesarean delivery (OR: 0.76, 95%CI: 0.70–0.82). In addition, higher maternal age (OR: 1.06, 95%CI: 1.04–1.09), application of oxytocic agents (OR: 0.55, 95%CI: 0.42–0.72), and obesity (OR: 2.25, 95%CI: 1.51–3.34) were associated with the outcome. Ranking of predictors indicate that cervical dilatation is the most relevant predictor derived from the regression model. Conclusions Advanced cervical dilatation at the time of admission to labor ward does not explain lower emergency cesarean delivery rates in Turkish and Lebanese migrant women, despite the fact that this is the strongest among the predictors for emergency cesarean delivery identified in this study.

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A guide to aid the selection of diagnostic tests

Cara S Kosack, Anne-Laure Page, Paul Klatser (2017)

Abstract In recent years, a wide range of diagnostic tests has become available for use in resource-constrained settings. Accordingly, a huge number of guidelines, performance evaluations and implementation reports have been produced. However, this wealth of information is unstructured and of uneven quality, which has made it difficult for end-users, such as clinics, laboratories and health ministries, to determine which test would be best for improving clinical care and patient outcomes in a specific context. This paper outlines a six-step guide to the selection and implementation of in vitro diagnostic tests based on Médecins Sans Frontières’ practical experience: (i) define the test’s purpose; (ii) review the market; (iii) ascertain regulatory approval; (iv) determine the test’s diagnostic accuracy under ideal conditions; (v) determine the test’s diagnostic accuracy in clinical practice; and (vi) monitor the test’s performance in routine use. Gaps in the information needed to complete these six steps and gaps in regulatory systems are highlighted. Finally, ways of improving the quality of diagnostic tests are suggested, such as establishing a model list of essential diagnostics, establishing a repository of information on the design of diagnostic studies and improving quality control and postmarketing surveillance.

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Infant Group B Streptococcal Disease Incidence and Serotypes Worldwide: Systematic Review and Meta-analyses

Lola Madrid, Anna C Seale, Maya Kohli-Lynch … (2017)

Abstract Background Group B Streptococcus (GBS) remains a leading cause of neonatal sepsis in high-income contexts, despite declines due to intrapartum antibiotic prophylaxis (IAP). Recent evidence suggests higher incidence in Africa, where IAP is rare. We investigated the global incidence of infant invasive GBS disease and the associated serotypes, updating previous estimates. Methods We conducted systematic literature reviews (PubMed/Medline, Embase, Latin American and Caribbean Health Sciences Literature [LILACS], World Health Organization Library Information System [WHOLIS], and Scopus) and sought unpublished data regarding invasive GBS disease in infants aged 0–89 days. We conducted random-effects meta-analyses of incidence, case fatality risk (CFR), and serotype prevalence. Results We identified 135 studies with data on incidence (n = 90), CFR (n = 64), or serotype (n = 45). The pooled incidence of invasive GBS disease in infants was 0.49 per 1000 live births (95% confidence interval [CI], .43–.56), and was highest in Africa (1.12) and lowest in Asia (0.30). Early-onset disease incidence was 0.41 (95% CI, .36–.47); late-onset disease incidence was 0.26 (95% CI, .21–.30). CFR was 8.4% (95% CI, 6.6%–10.2%). Serotype III (61.5%) dominated, with 97% of cases caused by serotypes Ia, Ib, II, III, and V. Conclusions The incidence of infant GBS disease remains high in some regions, particularly Africa. We likely underestimated incidence in some contexts, due to limitations in case ascertainment and specimen collection and processing. Burden in Asia requires further investigation.

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Author and article information

Contributors

Juliet Nsimire Sendagala

Melanie Etti:

ORCID: https://orcid.org/0000-0002-3265-635X

Rose Azuba

Joseph Peacock:

ORCID: https://orcid.org/0000-0002-8767-7377

Kirsty Le Doare:

ORCID: https://orcid.org/0000-0002-5104-085X

Journal

Journal ID (nlm-ta): Open Forum Infect Dis

Journal ID (iso-abbrev): Open Forum Infect Dis

Journal ID (publisher-id): ofid

Title: Open Forum Infectious Diseases

Publisher: Oxford University Press (US )

ISSN (Electronic): 2328-8957

Publication date Collection: December 2024

Publication date (Electronic): 10 March 2025

Publication date PMC-release: 10 March 2025

Volume: 11

Issue: Suppl 3 , Neonatal and Young Infant Infection in Uganda: The PROGRESS Study

Pages: S182-S186

Affiliations

Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit , Entebbe, Uganda

Institute for Infection and Immunity, St George's, University of London , London, UK

Makerere University—Johns Hopkins University (MUJHU) Research Collaboration , Kampala, Uganda

Department of Livestock and Industrial Resources, Makerere University College of Veterinary Medicine, Animal Resources and Biosecurity , Kampala, Uganda

Institute for Infection and Immunity, St George's, University of London , London, UK

Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit , Entebbe, Uganda

Institute for Infection and Immunity, St George's, University of London , London, UK

Makerere University—Johns Hopkins University (MUJHU) Research Collaboration , Kampala, Uganda

Author notes

Kirsty Le Doare denotes senior authorship.

Correspondence: Melanie Etti, MBChB, MA, MPH, Institute for Infection and Immunity, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK ( melanie.etti@ 123456doctors.org.uk ); Joseph Peacock, MSc, BSc, Institute for Infection and Immunity, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK ( jpeacock@ 123456sgul.ac.uk ).

Potential conflicts of interest . K.L.D. received funding from Pfizer and MinervaX for research at the Institute for Infection and Immunity at St George's, University of London, for work that is unrelated to this manuscript. She has received no personal funds. All other authors reported no conflicts of interest.

Author information

Melanie Etti https://orcid.org/0000-0002-3265-635X

Joseph Peacock https://orcid.org/0000-0002-8767-7377

Kirsty Le Doare https://orcid.org/0000-0002-5104-085X

Article

Publisher ID: ofae605

DOI: 10.1093/ofid/ofae605

PMC ID: 11891131

SO-VID: 6b5d414a-a430-4042-9d90-e771e4678d88

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 11 December 2023

Date: 30 September 2024

Date accepted : 10 October 2024

Page count

Pages: 5

Funding

Funded by: Bill and Melinda Gates Foundation, DOI 10.13039/100000865;

Award ID: OPP1189053

Rapid Point-of-care Testing to Inform Intrapartum Treatment of Group B Streptococcus–Colonized Women in Uganda

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Introduction

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Most cited references 22

Advanced cervical dilatation as a predictor for low emergency cesarean delivery: a comparison between migrant and non-migrant Primiparae – secondary analysis in Berlin, Germany

A guide to aid the selection of diagnostic tests

Infant Group B Streptococcal Disease Incidence and Serotypes Worldwide: Systematic Review and Meta-analyses

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