COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs for the Detection of COVID-19

NCT04703140 | Terminated

• 1 other identifier: 2020/09
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The Covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. Moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (RT-PCR) on a nasopharyngeal sample taken by swab. This technique is expensive (54€) and its production time is several hours. Alternative methods are in progress, including, rapid diagnostic tests. The MEMS microfluids and nanostructures (MMN) laboratory, in partnership with the Institut Chimie Biologie Innovation (CBI) (Paris, 75005), have developed a portable test "COVIDISC", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (RT-LAMP). The "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic RT-PCR (sensitivity of 7 copies per μl, specificity 100%). The objective of this study is to validate the in vitro diagnostic medical device, COVIDISC, with the standard nasopharyngeal RT-PCR test.

Conditions

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Comparaison of the performance of the diagnostic performance (sensitivity, sensibility) of RT-LAMP test using the RT-PCR test as a reference.

  Calculate sensitivity, Specificity, Positive predictive value, Negative predictive value, Positive and negative likelihood report COVIDISC fast, antigenic test compared to RT-PCR Covid-19 reference test conducted in the laboratory

  Day 0

Secondary Outcomes (1)

• Compare the diagnostic performances of RT-LAMP to clinical diagnosis.

  Day 0

Study Arms (1)

nasopharyngeal swabs

EXPERIMENTAL

One patient will have 2 nasopharyngeal for PCR and COVIDISC

Diagnostic Test: Rapid Diagnostic Test vs PCR

Interventions

Rapid Diagnostic Test vs PCR DIAGNOSTIC_TEST

2 nasopharyngeal swabs taken for PCR and COVIDISC

nasopharyngeal swabs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing nasopharyngeal SARS CoV2 RT-PCR testing

You may not qualify if:

• \< 18 years old
• Having signed a written informed consent form,
• Affiliation to the social security system.

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CHI Robert Ballanger

Aulnay-sous-Bois, France

Location

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

• ROSSI Benjamin, MD

  Hopital Robert Ballanger

  PRINCIPAL INVESTIGATOR

• NGUYEN Lee, MD

  CMC Ambroise Paré

  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

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 11, 2021
• Study Start: January 27, 2021
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)