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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Performance of COVIDISC Rapid Test for Diagnosis of SARS-CoV-2

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: Rapid Diagnostic Test vs PCR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nasopharyngeal swabs<br>One patient will have 2 nasopharyngeal for PCR and COVIDISC | Diagnostic Test: Rapid Diagnostic Test vs PCR<br>* 2 nasopharyngeal swabs taken for PCR and COVIDISC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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