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

COVID-19 Clinical Trial

— COVIDISC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04703140
• Other study ID #: 2020/09
• Status: Terminated
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: May 4, 2021

Study information

• Verified date: June 2022
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 192
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Diagnostic Test:
• Rapid Diagnostic Test vs PCR
2 nasopharyngeal swabs taken for PCR and COVIDISC

Locations

Country	Name	City	State
France	CHI Robert Ballanger	Aulnay-sous-Bois

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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