The laboratory

Clinicore is a high-complexity clinical laboratory in Mandeville, Louisiana, running mass spectrometry, molecular and routine chemistry for ordering clinicians.

What the laboratory was built to do

Most of what a clinical laboratory offers is well served by assays that already exist, and Clinicore uses those where they are good. The laboratory was built for the cases where they are not.

Steroid hormones are the clearest example. They are small molecules of near-identical structure — cortisol and cortisone differ by a single oxidation state, and 21-deoxycortisol, 11-deoxycortisol and corticosterone are isobaric. An antibody raised against one binds the others, so an immunoassay reports the target plus its look-alikes. Measured that way, 17-hydroxyprogesterone has been shown to read two to three and a half times the structurally verified value, with unnecessary follow-up procedures in the majority of patients as a result.

That is a measurement problem, and it has a measurement answer: separate the compounds chromatographically, then confirm each by a mass-to-charge transition specific to that molecule. Methods M1 sets out the evidence.

Two tiers, stated on every page

Clinicore runs FDA-cleared or FDA-approved assays where a good one exists, and laboratory-developed methods where the clinical question demands one — the LC-MS/MS steroid panel, definitive toxicology, and the custom molecular panel.

Every test page on this site states which tier it belongs to, because that is the honest answer to a clinician asking whether a result is comparable with another laboratory’s. For a cleared assay, largely yes. For the LC-MS/MS panel, it is method-specific, which is the point of running it.

A laboratory claiming every assay on its menu is novel would not be describing engineering judgment.

Small volume, by design

The endocrine hormone panel runs on 0.15 mL of serum. Once the volume a method needs drops that far, the collection stops requiring a phlebotomist — and timed collection and at-home collection become practical rather than logistically difficult.

That is what the Tasso capillary device and the Mitra microsample are for, and it is why the laboratory ran a controlled vein-to-capillary comparison rather than assuming equivalence.

Who does what

Novel method design 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 reviewed and approved by the Medical Director before it is used for patient testing.

That separation is deliberate, and most laboratories never articulate it: the designer of a method should not be its sole validator. Independent execution is what makes a validation meaningful rather than self-confirming. See validation and the team.

What we publish that others do not

The limits. Every analyte page states its reportable range or assay cutoff with units, and where that range does not cover the full clinical question, the page says so explicitly.

Dihydrotestosterone is reportable from 10.125 ng/dL — which covers androgen excess, and does not cover suppression monitoring during 5α-reductase inhibitor therapy. Estradiol is fit for postmenopausal assessment where the decision turns on whether it is below about 10 pg/mL, and is not fit for monitoring aromatase-inhibitor suppression. The vitamin D method measures D3, so a patient supplementing with ergocalciferol carries D2 it does not capture.

None of that is required of us. It is published because a limitation a reader finds on their own costs more credibility than one stated up front, and because a clinician deciding whether to send a specimen deserves to know before they send it.

Practicalities

Location800 N Causeway Blvd, Suite 300, Mandeville, LA 70448
Turnaround24–48 hours from arrival at the laboratory
Service areaAll U.S. states except New York and California
CredentialsCLIA, COLA, CAP proficiency testing