Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19
- Conditions
- SARS-CoV 2COVID-19
- Interventions
- Device: Capillary and salivary samplingDevice: Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.
- Registration Number
- NCT04405492
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1210
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Population 3 : Lay users Capillary and salivary sampling Suitability of rapid test in view of its intended purpose for self-testing Population 1 : Patients Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Hospitalized patients, positive or suspected of SARS-CoV-2 infection Population 2 : Hospital caregivers exposed to SARS-CoV-2 Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Longitudinal study of a hospital caregiver cohort
- Primary Outcome Measures
Name Time Method Clinical performance of several diagnostic tests : tests based either on detection of the virus SARS-CoV-2 or detection of human antibodies generated in response to infection Total duration of the study is 10 months * Tests based on detection of the virus SARS-CoV-2 (antigenic rapid tests, molecular tests, proteomic tests): sensibility and specificity compared to RT-PCR (Ct) in salivary samples and nasopharyngeal swabs from patients and cargivers included in the study
* Tests based on detection of human antibodies generated in response to infection (rapid immunodiagnostic tests, ELISA): sensibility and specificity compared to RT-PCR (Ct) and ELISA (antibody titer) in blood or serum from patients and cargivers included in the study
- Secondary Outcome Measures
Name Time Method Description of the incidence of infection among hospital caregivers, time to seroconversion according to clinical form, medium-term antibody persistence Caregivers will be included in the study for 9 months. After inclusion (Day 0), follow-up visits at Day 15, 1 Month, 3 Months, 6 Months, 9 Months 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.
Sensitivity and specificity of antigenic rapid tests, molecular tests, proteomic tests according to the sample used (salivary samples or nasopharyngeal swabs) and according to the duration of the symptoms Total duration of the study is 10 months Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded.
Sensitivity and specificity of immunological, antigenic, molecular and proteomic tests according to symptom duration, stage of the disease: asymptomatic, ambulatory, hospitalized, ventilated Total duration of the study is 10 months Hospitalized patients, positive or suspected of SARS-CoV-2 infection are included in the study. Medical data related to COVID-19 infection will be recorded.
Caregivers will be asked information about their health status related to a possible COVID-19 infection: symptoms if any, symptoms duration, severity.Sensitivity and specificity of immunodiagnostic tests according to the sample used (serum and capillary blood) and according to the duration of the symptoms Total duration of the study is 10 months Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded.
Suitability of rapid tests in view of its intended purpose for self-testing 4 months 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.