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

NCT ID: NCT04703140

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2021-05-04

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.

Detailed Description

All outpatients and hospitalized patients (intensive care unit, internal medicine service and emergency service) will be proposed to participate to the study after assessment of eligibility criteria by the investigator. The investigator will collect a written consent of the patient or from the support person or a familiar if, the patient is not in condition to consent. Patient's participation will be notified in his medical record.

After inclusion of patient, the nurse will collect general and clinical data and 2 nasopharyngeal swabs will be taken. One sample to test the prototype of the RT-LAMP and the second one to carry out the classic RT-PCR. The results will be collected and compared in a second step.

Conditions

COVID-19; SARS-CoV-2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

nasopharyngeal swabs

One patient will have 2 nasopharyngeal for PCR and COVIDISC

Group Type: EXPERIMENTAL

Rapid Diagnostic Test vs PCR

Intervention Type: DIAGNOSTIC_TEST

2 nasopharyngeal swabs taken for PCR and COVIDISC

Interventions

Rapid Diagnostic Test vs PCR

2 nasopharyngeal swabs taken for PCR and COVIDISC

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients undergoing nasopharyngeal SARS CoV2 RT-PCR testing

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROSSI Benjamin, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Robert Ballanger

NGUYEN Lee, MD

Role: PRINCIPAL_INVESTIGATOR

CMC Ambroise Paré

Locations

CHI Robert Ballanger

Aulnay-sous-Bois, , France

Countries

France

Other Identifiers

2020/09

Identifier Type: -

Identifier Source: org_study_id