Detection of SARS-CoV-2 (COVID-19) by SERS Spectroscopy Combined With Artificial Intelligence (Kaïssa Covid)

Detection of SARS-CoV-2 by SERS Spectroscopy

SARS-CoV-2 infection was identified as responsible for several cases of pneumonia and acute respiratory distress syndromes described in Wuhan, Hubei Province, China in December 2019. A global epidemic has spread since and the Director General of the World Health Organization (WHO) declared in March 2020 the state of a global pandemic.

As the spread of the virus accelerates, several countries are implementing containment strategies to stem the epidemic.

The context of an influx of patients and congestion in healthcare establishments requires rapid and reliable diagnostic solutions for SARS-CoV-2 infection in order to enable patients to be properly referred. These solutions will represent fundamental tools in the management of new epidemic waves, both in terms of health and economics.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19

Detailed Description

Spectroscopy is the discipline of studying the interactions between light and matter, in order to perform analyzes unmatched in terms of the speed of data acquisition. Depending on the spectral ranges used by the sensors, it is possible to carry out molecular (molecular and vibrational spectroscopy) or elementary (atomic spectroscopy) analyzes.

As part of this project, GreenTropism has selected Surface Enhanced Raman Scattering (SERS) technology as a spectral technique. The scientific literature reports several cases of use of SERS technology for virus analysis, under variable conditions: variable viral loads, after amplification, use of substrates enriched in antigens.

The SERS allows an analysis of a sample deposited on a substrate on average (from fifteen seconds to 10 minutes depending on the devices and the presence of complementary imaging). Already proven for the identification of viruses on strains pathogenic for humans and animals, its deployment is slowed down by the complexity of the data to be processed.

These spectra acquisition technologies require the joint use of statistical tools and multivariate analyzes to allow sample discrimination (classification) and / or quantification. Until recently, the capacity and performance of statistical tools were limited by the available computational capacities. The lifting of this technological lock allowed the advent and democratization of Artificial Intelligence (AI) techniques theorized in the 1960s and applied today.

GreenTropism's Kaïssa, AI tool, in addition to processing big data, has been designed and trained specifically for processing spectral data and automating all of the algorithmic chains needed to go from spectrum support to its interpretation, and the presentation of the final answer.

The analysis of chemometric data, for the purpose of classification, implements several types of algorithms that Kaïssa uses, combining them automatically to obtain the best possible analyzes of these data. These algorithms are divided into two large groups: mathematical preprocessing and classification models.

The combination of photonic technologies (here SERS) and AI allows real-time analyzes of multiple substrates, without a priori knowledge of the user on the sample and without prior expertise. These characteristics make it a valuable tool for diagnosing SARS-CoV-2 infection in the context of Point Of Care.

In a work carried out between the months of March and June 2020, several models showed, on test databases not integrated in the learning, performance of discrimination between positive and negative patients for SARS-CoV-2 according to RT-PCR equivalent to Youden indices of 0.6 to 0.92. On the other hand, these models have highlighted a variability in the use of samples which results in a drop in performance during tests on statistically independent databases requiring additional spectral acquisitions, leading today to the presentation of this report project.

• Study Type: Observational
• Enrollment (Actual): 712

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient presenting to the GhPSJ for a consultation or hospitalization and for whom a PCR test for SARS-CoV-2 is prescribed as part of his care

Description

Inclusion Criteria:

• Patient aged ≥ 18 years
• Patient presenting to the GhPSJ for a consultation or hospitalization and for whom a PCR test for SARS-CoV-2 is prescribed as part of his care
• French-speaking patient.

Exclusion Criteria:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection
• Patient objecting to the use of their data for this research.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the performance in terms of sensitivity and specificity of the technique by spectral analysis combined with artificial intelligence for the SARS-CoV-2 virus versus to the reference technique by RT-qPCR	Detection of the SARS-CoV-2 virus with the technique by spectral analysis combined with artificial intelligence and with the reference technique by RT-qPCR (Xpert Xpress SARS-CoV-2 or Simplexa™ COVID-19 Direct assay)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the detection limit of the technique by spectral analysis combined with artificial intelligence	Detection limit of the technique by spectral analysis combined with artificial intelligence compared to the CTs of RT-qPCR (Xpert Xpress SARS-CoV-2 or Simplexa™ COVID-19 Direct assay)	Day 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: artificial intelligence
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Kaïssa Covid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No