Clinical trials

As part of the CE marking of a hepatitis B diagnostic kit, the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR (RE 2017/746). Cerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients with hepatitis B virus and whose viral load is positive. This prospective collection will be carried out in 3 laboratories of the Cerba Healthcare group.

As part of the CE marking of a hepatitis C diagnostic kit, the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR (RE 2017/746). Cerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients suffering from the virus hepatitis C and whose viral load is positive. This prospective collection will be carried out in 4 laboratories of the Cerba Healthcare group.

The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population . Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies.

The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy.

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.

Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population