Case studies
Some successful collaborations to show you our expertises
Clinical Chemistry
Validation of 26-parameters of immunoassay system to obtain CE Marking for a Top10 IVD company
- Provision of 25,000+ retrospectively collected samples over the entire concentration range
- Analytical performance: Linearity, precision, reproducibility…
- Clinical performance: Method comparison against the Cerba Standard-of-Care
Respiratory, Infectious Diseases
Validation of respiratory panel (SARS-Cov-2, Influenza, RSV) for a Korean company
- Retrospectively and prospectively collected positive and negative nasopharyngeal swab samples
- Clinical performance evaluation by method comparison against Gene Xpert and BioFire® FilmArray® RP2.1+ Panel
Metabolic Diseases
- Logitudinal prospective collection of NASH and non-NASH confirmed patients with FIB-4 and NFS scores
- Matched pairs of serum and whole blood samples
Tropical fever, Infectious Diseases
Validation of a tropical fever disease panel (dengue, malaria, leptospirosis etc) and the molecular PoC instrument
- Prospectively collected positive and negative matched pair serum and plasma samples from the same donor
- Clinical performance evaluation by method comparison against the BioFire® FilmArray® Global fever Panel
Gastrointestinal Infectious diseases
Clinical validation of new GI panel with fresh stool samples in Africa (Ivory Coast) for an US company
- Prospectively collected 1,000+ fresh stool samples
- Matched pairs: raw stool and stool in carry blair
- Clinical performance evaluation by method comparison against the BioFire® FilmArray® GI Panel
Hemostasis
Long-term partnership with a French IVD manufacturer for the validation of a new platform for hemostasis
- Analytical performance: Linearity, precision, repeatability, reproducibility…
- Clinical performance: Method comparison against the Standard-of-Care
Usability Study
Sommative evaluation of new HLA-B27 and FII typing assays to ensure the correct use understanding of the information by the users
- Carrying out tests according to the IFU by qualified and trained technicians
- Resulst analysis, interview and questionary by clinical pathologists
Genetics
Validation of cfDNA Platform NIPT for CE Marking.
- Prospective low interventional study to collect 912 T13, T18 and T21 samples from pregnant women
- Usability study in French medical biology laboratories and hospitals
- Clinical performance of instrument and software
We have been collaborating with Cerba Laboratory for the past six years on Clinical Performance Evaluation Studies for our Blood Virus Infectious Disease Program. During this period, our partnership has consistently been successful. We would like to express our gratitude for their commitment and professionalism in our collaboration.
The team at Cerba has regularly demonstrated a high level of professionalism, adhering to protocols and ensuring that our studies run smoothly. Their contribution has been key to the success of our projects.