Feasibility and Analytic Performance of TestNPass (IVDMD) for CoViD-19 Diagnosis on Saliva Sample

NCT04654442 | Completed

• 2 other identifiers: 38RC20.3782020-A03087-32
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

COVID19 pandemic and SARS-CoV-2 rapid progression worldwide are already historical landmarks of the 21st century owing to the magnitude of the event and the collective response that populations have adopted to face such threat. This menace has imposed an unprecedented reactivity to promptly deliver answers in various fields and specifically in termes of diagnostic capabilities. The very first tests to be used were based on PCR reactions and on deep nasopharyngeal sampling. But this has shown to be insufficient to prevent contaminations and limit the progression of the disease. This approach requires important infrastructure thus limiting the extent to which it can be delivered. Moreover, nasopharyngeal swab is highly intrusive and therefore is not suitable for repeated testing of asymptomatic patients in surveillance programs. Actual need is based on new tests offering new capabilities both in terms of wide range availability, ease of use and reduced time-to-result duration. Such tests, affordable and that can be performed outside the lab would ultimately relief pressure on healthcare workers and laboratory facilities as well as help test massively wide range of populations thus limiting viral dissemination Such innovating test device has been developped by the start-up "Grapheal" and the present study will ultimately demonstrate the feasibility of COVID-19 diagnostic using this test.

Conditions

Covid19; SARS-CoV-2

Keywords

saliva; IVDMD (in vitro diagnosis medical device)

Outcome Measures

Primary Outcomes (1)

• Feasibility of TestNPass IVDMD for CoViD19 diagnosis on saliva samples.

  Electric signal obtained in TestNPass Graphene Biosensor for samples collected from known COVID19 positive patients.

  DAY0 (single visit study, day of COVID19 diagnosis)

Secondary Outcomes (5)

• TestNPass IVDMD swiftness

  DAY0 (single visit study, day of COVID19 diagnosis)

• TestNPass IVDMD ease of use

  DAY0 (single visit study, day of COVID19 diagnosis)

• Analytics performance (sensibility) of TestNPass IVDMD

  DAY0 (single visit study, day of COVID19 diagnosis)

• Analytics performance (specificity) of TestNPass IVDMD

  DAY0 (single visit study, day of COVID19 diagnosis)

• Correlation of TestNPass electric signal intensity with RT-PCR Cycle threshold

  DAY0 (single visit study, day of COVID19 diagnosis)

Study Arms (2)

Cases

30 cases will be recruited : Patient diagnosed by RT-PCR for a COVID19 at Grenoble University Hospital

Diagnostic Test: TestNPass

Controls

30 controls will be recruited : Patient suspected for a COVID-19 but negative by RT-PCR for a COVID19 at Grenoble University Hospital

Diagnostic Test: TestNPass

Interventions

TestNPass DIAGNOSTIC_TEST

Patients will undergo saliva sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient suspected of a COVID19

You may qualify if:

• Men or Women over 18 years old
• suspect of COVID19 and consulting for a diagnosis at Grenoble University Hospital.
• Duly informed and not opposed to participation at GraphealNPass' study
• Affiliated to french social security.

You may not qualify if:

• Patients protected by law (minors, pregnant or breastfeeding woman, patient under guardianship or deprived of his/her liberty or hospitalized without his/her consent)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Grapheal: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

Related Publications (5)

• Brengel-Pesce K, Morand P, Schmuck A, Bourgeat MJ, Buisson M, Bargues G, Bouzid M, Seigneurin JM. Routine use of real-time quantitative PCR for laboratory diagnosis of Epstein-Barr virus infections. J Med Virol. 2002 Mar;66(3):360-9. doi: 10.1002/jmv.2153.

  PMID: 11793388 BACKGROUND

• Danis K, Epaulard O, Benet T, Gaymard A, Campoy S, Botelho-Nevers E, Bouscambert-Duchamp M, Spaccaferri G, Ader F, Mailles A, Boudalaa Z, Tolsma V, Berra J, Vaux S, Forestier E, Landelle C, Fougere E, Thabuis A, Berthelot P, Veil R, Levy-Bruhl D, Chidiac C, Lina B, Coignard B, Saura C; Investigation Team. Cluster of Coronavirus Disease 2019 (COVID-19) in the French Alps, February 2020. Clin Infect Dis. 2020 Jul 28;71(15):825-832. doi: 10.1093/cid/ciaa424.

  PMID: 32277759 BACKGROUND

• Le Marechal M, Morand P, Epaulard O, Nemoz B. COVID-19 in clinical practice: A narrative synthesis. Med Mal Infect. 2020 Nov;50(8):639-647. doi: 10.1016/j.medmal.2020.09.012. Epub 2020 Sep 29.

  PMID: 33007400 BACKGROUND

• Seo G, Lee G, Kim MJ, Baek SH, Choi M, Ku KB, Lee CS, Jun S, Park D, Kim HG, Kim SJ, Lee JO, Kim BT, Park EC, Kim SI. Rapid Detection of COVID-19 Causative Virus (SARS-CoV-2) in Human Nasopharyngeal Swab Specimens Using Field-Effect Transistor-Based Biosensor. ACS Nano. 2020 Apr 28;14(4):5135-5142. doi: 10.1021/acsnano.0c02823. Epub 2020 Apr 20.

  PMID: 32293168 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

Related Links

• Dipankar, K., Bouchiat, V., Marty, L., \& Bendiab, N. (2016). Method of forming a graphene device (Patent No. WO2016142400A1).
• Santé Publique France. (2020). Coronavirus : chiffres clés et évolution de la COVID-19 en France.
• Bouchiat, V. (2020). Instruction for Use of the SARS-Cov-2 Diagnostic test kit / TestNPass / GRAPHEAL.
• Conseil Scientifique. (2020). Avis n°9 du Conseil scientifique COVID-19.
• WHO. (2020a). Coronavirus Disease (COVID-19) Dashboard.
• WHO. (2020b). WHO Media Briefing on COVID-19 - 16 March 2020.
• WHO SOLIDARITY trial consortium. (2020). Repurposed antiviral drugs for COVID-19 -interim WHO SOLIDARITY trial results WHO. MedRxiv.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva Nasopharyngeal swab

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Benjamin Némoz, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 4, 2020
• Study Start: March 4, 2021
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

FR (1)