How a method becomes reportable
Clinicore operates in compliance with CLIA as a high-complexity clinical laboratory, CLIA ID 19D2139173, is accredited by COLA, and participates in College of American Pathologists proficiency testing — externally supplied, blinded, and graded by a third party.
Every method the laboratory runs is validated before it is used for patient testing, and reviewed and approved by the Medical Director before a single result is reported.
What validation establishes
A validation answers three questions: does the method measure what it claims to measure, does it do so accurately across the range it will report, and does it keep doing so.
Clinicore answers them the same way on every platform, using three kinds of material:
| Platform | Patient material | Fortified material | External reference |
|---|---|---|---|
| LC-MS/MS steroids | Paired donor specimens, venous and capillary | Certified reference materials in stripped serum, eight calibrator levels | CAP proficiency testing |
| Definitive toxicology | Patient specimens | Stripped serum spiked at known concentrations | CAP proficiency testing |
| Molecular qPCR | Extracted samples | Synthetic DNA, whole organism pools, purified genomic DNA | Characterised commercial controls, and an exclusivity panel of near neighbours |
The principle is the same across all three. Patient specimens demonstrate real-world performance. Fortified material establishes accuracy against known values across the full measuring range — patient specimens never arrive with a known truth value, and fortified material does. External programs provide blinded third-party verification.
Where a method has no proficiency testing program available, the laboratory verifies its accuracy by other means on a defined schedule, as CLIA requires.
Who validates a method
Novel method design at Clinicore is done by the founder. Validation of those methods is executed by laboratory staff rather than by the person who designed them, and every method is approved by the Medical Director before patient testing begins.
That separation is deliberate. The designer of a method should not be its sole validator — independent execution is what makes a validation meaningful rather than self-confirming.
Reportable limits
The limits published on each test page are not the instrument’s detection floor. Each is set at a concentration the method reproduces reliably under production conditions, at full daily throughput. Sensitivity studies demonstrate performance below these limits; the laboratory publishes the concentration it can deliver every day rather than the one it achieved once.
Every analyte’s reportable range or assay cutoff is published on its own page in the test catalog.