Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)

It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection.

The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD).

The SRDK0921 system (kit and software) is intended:

• to calculate a score of subclinical rejection in kidney transplant patients
• as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.

Inclusion Criteria:

• Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
• Subjects transplanted from living or deceased donors.
• Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
• Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
• Subjects under standard immunosuppressive treatments.

Exclusion Criteria:

• Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
• Subjects that have stopped immunosuppressive treatments.

Samples and data from patients included in the DIVAT biocollection are the leftover specimens already used in the Proof-Of-Concept study. All those specimens meet the inclusion/exclusion criteria