ANALYTICAL TESTING SERVICES

Explore our Analytics page to see how MRN Analytics brings precision and reliability to every stage of your diagnostic kit evaluation. From platform compatibility to in-depth assay performance metrics, this section outlines the rigorous, data-driven approach we take to ensure your product meets the highest standards of accuracy and consistency.

MRN Analytics specializes in the verification and validation testing of your diagnostic kit. This can be done on one of our many testing platforms, which span instruments ranging from point-of-care rapid test readers to automated platforms for serology and molecular testing.

As your testing partner, we are committed to delivering accurate and consistent results across a wide range of diagnostic platforms to evaluate your device. Some of these protocols include multiple stability programs, assay precision, interfering substances, Hook-effect, in-silico analysis, LOD determinations, and other assays to meet the claims of your diagnostic device.

ANALYTICAL SERVICES

REGISTRATIONS

MRN Diagnostics proudly holds multiple registrations, permits, and licenses to run our business at the highest level of Quality and compliance. MRN Diagnostics continually strives to achieve the highest level of customer service and compliance in our industry.

ISO 13485:2016
FDA Blood Establishment
FDA Registered Manufacturer
CDC Import Permits
CLIA Waived
Clinical Laboratory Licensed (COVID-19)
USDA Permit to transfer in the US

TESTING PLATFORMS

We screen and qualify materials for a variety of projects for both internal and client-requested projects using a variety of different testing platforms and assays. Platforms we currently utilize include:

Abbott Architect i2000SR
Ortho VITROS® ECiQ
Cepheid® GeneXpert
Abbott Alinity I

UNTRAINED-USER LABS

An important branch of our department includes testing for clinical studies and collections, as well as point-of-care studies where our employees may act as untrained users for newly developed assays.

VALIDATION TESTING

In concert with our manufacturing division, we perform validation testing on many controls manufactured here at MRN Diagnostics which can include studies like use life, shelf life, precision, and freeze/thaw cycling to challenge the controls we develop and ensure their continued performance for our clients and customers.MRN Analytics' testing capabilities include, but are not limited to, testing of rapids, ELISAs, colorimetric assays, and bacterial limit-of-detection studies.