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Limit of Detection Panels

CUSTOM

Our Limit of Detection (LOD) Panel Development service provides comprehensive support for determining and validating the analytical sensitivity of diagnostic assays. This service includes the design, manufacture, and analytical testing of a custom LOD panel for your chosen diagnostic marker in your preferred matrix, such as clinical matrix, plasma, serum, urine, saliva, or purified biomaterials.

Panel Specifications

The final panel includes a negative control, a low positive sample near the detection limit, and a medium positive sample. Analytical validation is conducted in alignment with CLSI EP17-A2 guidelines to establish the assay’s LoD.

Expert Titration & Design

  • We perform controlled titrations to pinpoint your assay’s LoD range and build your panel around real-world detection thresholds.

CLSI-Compliant Validation

  • Full analytical testing aligned with regulatory standards. Includes replicates for confidence and compliance.

Ready-to-Use & Reliable

  • Each panel is stability-tested and comes with a Certificate of Analysis and analytical validation testing—perfect for regulatory submission, assay verification, or QC.

Take the guesswork out of sensitivity testing.
Partner with us to validate your assay with confidence.

Submit a Request

Matrix
Organism
Testing Format

info@mrndx.com

English (508) 384-0033

Portuguese / Spanish (508) 803-9020

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