Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19

NCT ID: NCT04405492

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2021-03-25

Brief Summary

Prospective study for clinical performance evaluation of COVID-19 diagnostic tests: detection of anti-SARS-CoV-2 antibodies by RDTs or ELISA (manual or automated), rapid diagnostic tests based on antigen detection, molecular or proteomic testing of SARS-CoV-2 (sensitivity, specificity, predictive values)

Detailed Description

Since initially reported in Wuhan, China, in late December 2019, the outbreak of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has spread globally, stressing many health systems especially intensive care unit (ICU) capacities thus resulting in high mortality. On 16 March 2020, WHO Director-General called on all countries to ramp up their testing programs as the best way to slow the advance of the coronavirus pandemic. Although the current gold standard for COVID-19 diagnosis remains real time reverse transcription-polymerase chain reaction (rRT-PCR), this technique has many shortcomings such as low sensitivity on nasopharyngeal swabs (70%). Multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices. Before these tests can be recommended, they must be validated in the appropriate populations and settings.

Funded by French Defense Innovation Agency (AID), ERap-CoV is a prospective clinical study which aims to assess clinical performances of serological and antigenic assays for the diagnosis of SARS-CoV-2 infection, in comparison with current diagnostic tests on the market (immunological, proteomic, molecular). The ERap-CoV research will extend the clinical validation of the first NG-Test IgM-IgG COVID-19 point-of-care immunodiagnostic test (NG Biotech), which has shown excellent biological performance, compatible with the recommendations of the Haute Autorité de Santé (HAS) for serological assays (sensitivity> 90% and specificity> 98%, 15 days after symptoms) (1). Finally, AID funding will be used to develop 100% French-made serological and antigenic RDTs in less than a year.

Conditions

SARS-CoV 2; COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Population 1 : Patients

Hospitalized patients, positive or suspected of SARS-CoV-2 infection

Group Type: EXPERIMENTAL

Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.

Intervention Type: DEVICE

After inclusion, demographic and medical data will be collected. Evaluated point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Clinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different clinical samples retrieved from the biobank.

For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.

Population 2 : Hospital caregivers exposed to SARS-CoV-2

Longitudinal study of a hospital caregiver cohort

Group Type: EXPERIMENTAL

Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.

Intervention Type: DEVICE

After inclusion, demographic and medical data will be collected. Point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken (D0). A follow-up at D15, M1, M3, M6, M9 will be done. At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit.

Cinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different samples retrieved from the biobank.

For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.

Population 3 : Lay users

Suitability of rapid test in view of its intended purpose for self-testing

Group Type: EXPERIMENTAL

Capillary and salivary sampling

Intervention Type: DEVICE

Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.

Interventions

Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.

After inclusion, demographic and medical data will be collected. Evaluated point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Clinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different clinical samples retrieved from the biobank.

For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.

Intervention Type: DEVICE

Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.

After inclusion, demographic and medical data will be collected. Point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken (D0). A follow-up at D15, M1, M3, M6, M9 will be done. At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit.

Cinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different samples retrieved from the biobank.

For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.

Intervention Type: DEVICE

Capillary and salivary sampling

Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

Common criteria for the 3 populations:

• Person subject to a justice protection measure

Population 1 (Patients):

• Refusal to participate by the patient / support person or close friend
• Patient not speaking French and not accompanied by a translator
• Patient under guardianship or curatorship
• Person under AME (State medical aid)

Population 2 (Caregivers):

• Refusal to participate

Population 3 (lay users):

• Refusal to participate
• Person not speaking French and not accompanied by a translator
• Person under AME (State medical aid)
• Person out of state to consent, under guardianship or curatorship
• Pregnant and lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Thierry Naas

Role: CONTACT

thierry.naas@aphp.fr

+33145212986

Anne-Marie Roque-Afonso

Role: CONTACT

anne-marie.roque@aphp.fr

+33145593720

Other Identifiers

APHP200556

Identifier Type: -

Identifier Source: org_study_id