Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19 (ERap-COV)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: COVID-19; SARS-CoV 2

Treatments: Device: Capillary and salivary sampling; Device: Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.

Study type: Interventional

Funder types: Other

Identifiers

NCT04405492

APHP200556

Details and patient eligibility

About

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)

Full 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.

Enrollment: 1,210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Common criteria for the 3 populations :

• Persons over 18 years of age
• Beneficiary or person entitled to a social security scheme

Population 1 (Patients) :

• Patients presenting for hospital admission on suspicion of SARS-Cov-2 infection based on the WHO definition and local guidelines
• Patient or relative/trusted person who has been informed about the study and has given informed consent.

Population 2 (Caregivers) :

• Caregivers exposed to COVID-19 in the course of their duties in the clinical departments of the Bicêtre and Paul Brousse hospitals.
• Caregiver who gave informed consent.

Population 3 (Lay Users) :

• Clients presenting themselves in one of the volunteer dispensary pharmacies located in the Île-de-France region, who will be called "lay users".
• Presentation on a study site

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,210 participants in 3 patient groups

Population 1 : Patients

Experimental group

Description:

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

Treatment:

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

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

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

Experimental group

Description:

Longitudinal study of a hospital caregiver cohort

Treatment:

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

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

Population 3 : Lay users

Experimental group

Description:

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

Treatment:

Device: Capillary and salivary sampling