The device is said to detect changes in vaginal bacteria and the resultant immune responses in pregnant women that could lead to a premature birth.
“We've known for some time that the vaginal microbiome can contribute to the risk of preterm birth, but now we have developed a device which in just a few minutes can report both the microbiome composition and inflammatory status of a sample collected during pregnancy," explains Imperial’s Dr David MacIntyre.
"This is the first rapid testing device of its kind and could be readily transferred to use in a clinical setting.
“This information could be used by doctors and patients to monitor risk of preterm birth but also to help optimise treatments, such as more selective use of antibiotics," adds Dr MacIntyre, Reader in Reproductive Systems Medicine, Institute of Reproductive & Developmental Biology Department of Metabolism, Digestion and Reproduction at the university.
This device uses direct-on-swab metabolic profiling by Desorption Electrospray Ionization Mass Spectrometry (DESI-MS), to analyse chemicals in a clinical swab to firstly identify vaginal bacteria.
By integrating metataxonomics and immune profiling data from samples, specific metabolome signatures can be used to predict both the composition of the vaginal microbiome and host inflammatory status.
The two-minute test developed by the March of Dimes Prematurity Research Center at Imperial was found to be just as effective as 'gold standard' chemical profiling tests such as Liquid Chromatography-Mass Spectrometry assays.
These tests require detailed sample preparation and extraction making them more time consuming (up to eight hours per assay), costly and difficult to introduce into routine bedside testing.
“An unhealthy microbiome is an important cause of preterm birth that, currently, we have no way of diagnosing or treating,” says Professor Phillip Bennett, from the Department of Metabolism, Digestion and Reproduction at Imperial College London.
“The introduction of this test into research studies, and into clinical practice should have a dramatic effect on our ability to prevent these preterm births and could have wider applications in other areas such as miscarriage and prevention of cervical cancer."
The team think the device may have broader applications to areas of women's health where the vaginal microbiome plays a role.
This includes bacterial vaginosis, HIV and HPV infection, cervical dysplasia, IVF failure and miscarriage.
The researchers now want to register the device and gain European regulatory approval with a view to make it available in North America.
They add that a miniature version of the device is now in the works that can be used more widely in clinics and would allow for bedside testing.
The Industry Club
In more Imperial-related news the University is behind a new initiative that looks to bring microbiome-based innovation to the forefront of investment from government, venture capitalists and industry.
Dubbed the Industry Club and launched by Imperial’s Microbiome Network, the enterprise involves over 70 medicine, engineering, and natural science investigators from the university with the aim of boosting research resources and exchange ideas.
The Club also looks to develop, standardisation and application of microbiome-based technologies as well as foster company participation that could include sponsored research and studentships, joint-funding proposals, workforce training and staff recruitment.
It is hoped that looking ahead, Industry Club members will agree to standards with regulators and involve the community on the possibilities of microbiome science.
"The idea behind the inception of the Microbiome Network is to scaffold interdisciplinary research and foster knowledge exchange," says Professor Marc-Emmanuel Dumas, Founding Director of the Microbiome Network and Chair in Systems Medicine.
Source: Nature communications
Published online: doi.org/10.1038/s41467-021-26215-w
“Direct on-swab metabolic profiling of vaginal microbiome host interactions during pregnancy and preterm birth.”
Authors: Pamela Pruski et al.