Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine (CEB Covid-19)

CerbaXpert

Status

Not yet enrolling

Conditions

SARS CoV 2 Infection

Treatments

Diagnostic Test: RIPH2

Study type

Interventional

Funder types

Other

Identifiers

NCT06144333

2022-A02195-38

Details and patient eligibility

About

Patients infected with SARS-CoV-2 can present with a wide range of manifestations clinical conditions, ranging from no symptoms to serious or chronic illness. The current gold standard test for the diagnosis of COVID-19 is based on a molecular test of reverse transcription polymerase chain reaction (RT-PCR), aimed at detecting the RNA of the virus in respiratory samples such as nasopharyngeal swabs or aspirates bronchial, other methods such as antigen tests and serological detection tests IgM and IgG in response to COVID-19 viral infection, can be used for the purposes of screening in the general population.

In this context of variety of existing tests, it is important to monitor the biological parameters related to COVID-19 pathology by tracking the accuracy, specificity and sensitivity of these tests in current clinical practice.

This research is a collection of additional biological samples with minimal impact on the intake usual care of the patients concerned, for the monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus, in terms of sensitivity, specificity, positive and negative predictive values, for the implementation of indicators quality monitoring of these kits.

Enrollment

7,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient over 18 years old
Patient coming for a biological analysis as part of the care for prevention, screening or monitoring of the pathogen target
Patient able to understand the information note and give a free and informed consent, on paper or digital media
Clinical patients:
- Control cases (all comers or ambulatory)
- Known positive for the pathology concerned
- Patient hospitalized for the pathology concerned
Pregnant or breastfeeding patient
Dialysis patient

Exclusion criteria

Patient already included in a research protocol
Patient having received medication or treatment experimental or investigational during the last four weeks before collection
Patient subject to a legal protection measure
Patient affiliated with state medical aid (AME)
Patient not affiliated to the compulsory Social Security system
Refusal or inability to provide signed informed consent
According to the investigator, the patient is not eligible for inclusion in the study