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)
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.
Device: 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.
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.
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.
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
Thierry Naas
+33145212986
thierry.naas@aphp.fr
Anne-Marie Roque-Afonso
+33145593720
anne-marie.roque@aphp.fr