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

Not Applicable

Terminated

• Conditions: COVID-19; SARS-CoV-2
• Interventions: Diagnostic Test: Rapid Diagnostic Test vs PCR

• Registration Number: NCT04703140
• Lead Sponsor: CMC Ambroise Paré

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.

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Study Start: 2021-01-27
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nasopharyngeal swabs	Rapid Diagnostic Test vs PCR	One patient will have 2 nasopharyngeal for PCR and COVIDISC

Primary Outcome Measures

Name	Time	Method
Comparaison of the performance of the diagnostic performance (sensitivity, sensibility) of RT-LAMP test using the RT-PCR test as a reference.	Day 0	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

Secondary Outcome Measures

Name	Time	Method
Compare the diagnostic performances of RT-LAMP to clinical diagnosis.	Day 0	The result of RT-LAMP test versus clinical evaluation defined by the clinical symptoms of the patients at the time of nasopharyngeal swab.

Trial Locations

Locations (1)

CHI Robert Ballanger; 🇫🇷 Aulnay-sous-Bois, France