Diagnostic Performance of the ID Now™ COVID-19 Screening Test Versus Simplexa™ COVID-19 Direct Assay

NCT04785898 | Completed

• 1 other identifier: COVID-IDNow
• Study Type: interventional
• Target: 1,265
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), first appeared in China, and then spread around the world. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei province, China. Very quickly, a new coronavirus was isolated from a sample of a patient's lower respiratory tract and the entire virus genome was sequenced. This new coronavirus, named SARS-CoV-2 for its genetic homology with SARS-CoV, has shown worldwide spread. Thus, on January 30, 2020, the World Health Organization (WHO) announced the COVID-19 epidemic as a threat to public health at the international level, then, in March 2020, the global situation degenerated into a pandemic. Johns Hopkins University has reported more than 7,600,000 cases of infections and more than 427,000 deaths as of June 13, 20203. Due to the rapid progression of the COVID-19 pandemic and the limited capacity of molecular laboratory tests, the concept of delocalized molecular tests appears to be relevant. Indeed, the urgent need to increase testing for COVID-19 has been clearly identified as an essential part of the strategy to combat the coronavirus worldwide. In fact, COVID-19 represents a major public health problem currently causing a rapidly increasing number of infections and significant morbidity and mortality worldwide. As of July 1, 2020, more than 10 million people worldwide have been infected with SARS-CoV-211. As of August 25, 2020, this tally is 23,741,562 cases of contamination and 813,820 deaths following Johns Hopkins University.

Conditions

Covid19

Keywords

Covid19; SARS-CoV2; Diagnosis performance

Outcome Measures

Primary Outcomes (1)

• Evaluate the diagnostic performance of the ID Now ™ COVID-19 test carried out by nurses in an emergency department in comparison with the reference PCR test: Simplexa ™ COVID-19 Direct

  Sensitivity of the ID Now ™ COVID-19 Test Compared to the Simplexa ™ COVID-19 Direct Assay

  Day 1

Study Arms (1)

Screening patients COVID-19 test

OTHER

As part of the patient's management, two nasopharyngeal swabs will be taken from the same nostril: * The first swab will be sent to the microbiology laboratory for analysis with the Simplexa ™ COVID-19 Direct assay so as not to impact the patient's diagnostic result. * The second swab taken as part of the research will be analyzed with the ID NowTM COVID-19 test located in the UAS by one of the nurses trained and authorized to use it. The choice to perform the ID Now ™ COVID-19 test in the emergency room and not in the laboratory is based on the supplier's instructions. Indeed, the nasopharyngeal swab is intended to be analyzed directly and not to be transported in a container which could hinder the quality of the sample. The discomfort or pain felt by the patient during the first sample can possibly influence the quality of the second. This could induce a bias. To minimize this bias, staff will be specifically trained in sampling.

Diagnostic Test: ID Now™ COVID-19 Screening Test

Interventions

ID Now™ COVID-19 Screening Test DIAGNOSTIC_TEST

Patients, meeting the eligibility criteria, are selected consecutively in the emergency room. The investigating doctor delivers the written information note, answers the patient's questions and obtains his free, informed and express consent. The patient has sufficient time to reflect to make the decision to participate in the study. His oral, free, informed and express consent will be traced in the computerized medical file on the day of its inclusion in the "COVID-IDNow" protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol.

Screening patients COVID-19 test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged ≥ 18 years
• Patient presenting to the emergency room of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient
• French-speaking patient
• Patient affiliated with social security or, failing that, with another health insurance system
• Patient capable of giving free, informed and express consent.

You may not qualify if:

• Pregnant or breastfeeding patient.
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• NguyenVan JC, Gerlier C, Pilmis B, Mizrahi A, Pean de Ponfilly G, Khaterchi A, Enouf V, Ganansia O, Le Monnier A. Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department. J Clin Virol. 2021 Dec;145:105021. doi: 10.1016/j.jcv.2021.105021. Epub 2021 Oct 30.

  PMID: 34768231 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Claude NGUYEN, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a diagnostic cohort study.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: November 9, 2020
• Primary Completion: December 22, 2020
• Study Completion: May 9, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

FR (1)