Clinical trial NCT04703140: COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs for the Detection of COVID-19
Official title: Evaluation of the Performance of COVIDISC Rapid Test for Diagnosis of SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
SARS-CoV-2
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Comparaison of the performance of the diagnostic performance (sensitivity, sensibility) of RT-LAMP test using the RT-PCR test as a reference.
timeFrame: Day 0
Secondary outcomes:
measure: Compare the diagnostic performances of RT-LAMP to clinical diagnosis.
timeFrame: Day 0
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: CHI Robert Ballanger
Study officials:
affiliation: Hopital Robert Ballanger
name: ROSSI Benjamin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CMC Ambroise Paré
name: NGUYEN Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: