evaluation of rapid diagnostic solutions, serological and molecular tests for covid-19

Conditions: SARS-CoV 2; COVID-19

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)

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.

Eligibility 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