The whole thrombin curve, where a clotting time shows nothing.
PT and aPTT stop at the first wisps of fibrin. They read the time to clot, not the engine behind it. Thrombin generation watches the full reaction: the lag before thrombin appears, the peak height, the time to peak, and the endogenous thrombin potential (ETP), the area under the curve — the net amount of thrombin generated once the sample's own inhibitors have acted. It is a global haemostasis assay used in specialist haemostasis laboratories to characterise both bleeding and prothrombotic phenotypes where the screening times sit inside the reference range. Technoclone's Ceveron TGA on the Ceveron t100/s100 analyser — we advise on running it so the curve means what it says.
A single thrombin-generation curve. The lag time is the delay before thrombin appears; the peak is the maximum thrombin concentration; time-to-peak is how long it takes to get there; and the endogenous thrombin potential (ETP) is the area under the whole curve. PT and aPTT would have stopped reading at the foot of the rising edge.
The four reported parameters are the lag time (delay to thrombin onset), the peak thrombin concentration, the time-to-peak, and the ETP (area under the thrombin curve — total thrombin generated). A clotting time captures only the start of the lag phase.
A clotting time tells you when the clot starts; the thrombogram tells you how much thrombin the sample actually generates.
How well it reproduces, what it correlates with, and where it stops.
Thrombin generation is a whole-curve global assay run in specialist coagulation laboratories; the precision below is what makes the curve usable. The named comparators are ST Genesia (Stago), the principal alternative automated TGA platform, and the CAT / Thrombinoscope system, the long-standing research reference. Each is presented on its own merits.
On the Ceveron t100 with the Ceveron TGA RC High trigger, between-run reproducibility runs to 4.2% CV for AUC, 7.4% for peak and 7.1% for lag. That is the precision a global assay needs to be clinically usable.
Between-run CVs from 19 replicate runs of normal control plasma. Manufacturer figures of "CV<5% / ~20 min" [MFR] are quoted separately as a manufacturer-stated claim, not as the peer-reviewed value.
Against DOAC level, across 559 patients (rivaroxaban, apixaban or edoxaban), the curve moves the way you would expect — lag Spearman +0.80, peak −0.72, AUC −0.55 — but the relationship is not tight enough to read a drug concentration off the curve.
For DOAC drug-level monitoring specifically, the evidence does not support routine DOAC monitoring (Meihandoest 2021); as a global haemostasis assay it is used in specialist haemostasis laboratories.
The principal alternative automated TGA platform. ST Genesia shows inter-series CV <7%, and against the CAT reference its peak runs higher by +16.4 ± 13.2% and its ETP by +17.8 ± 11.9% on Bland–Altman. TGA parameters are not numerically interchangeable across platforms.
Comparison is method-fair: ST Genesia is a capable automated platform on its own merits. Because trigger reagents and calibration differ, absolute peak and ETP values are platform-specific — interpret each against its own reference range, not against another instrument's.
The Calibrated Automated Thrombogram (CAT / Thrombinoscope) is the long-standing research reference method for thrombin generation, and the comparator the ST Genesia figures above are measured against. It is the chemistry the automated platforms set out to make routine and reproducible.
CAT is the established research-reference system; the Ceveron and ST Genesia data above describe the precision and agreement of the automated platforms relative to that reference. No instrument here is ranked above another — the read-out depends on trigger, calibration and platform.
The decision the assay changes is the one PT and aPTT cannot reach: characterising a bleeding or prothrombotic phenotype, or a treatment effect, when the screening times are normal. Read it whole, lag, peak, time-to-peak and ETP together, and against the platform's own reference range.
The product, the method, and where judgement sits.
Ceveron TGA is a fluorogenic assay: tissue factor and phospholipid trigger thrombin generation in plasma, and a fluorogenic substrate tracks thrombin activity continuously to build the thrombogram. On the Ceveron t100/s100 the run is automated, calibrated and reported as lag, peak, time-to-peak and ETP.
The products
Ceveron TGA reagents and the Ceveron t100/s100 analyser.
The method that matters
Fix the trigger and calibration, then read the whole curve. Because peak and ETP are platform-specific, the reporting cut-offs and reference ranges must be the analyser's own, never borrowed from another instrument.
What elixir does
We advise on assay set-up, calibration, parameter interpretation and the boundary with DOAC monitoring. Any modelling or computational work we offer is a human-led service, scoped per laboratory, never a product on the shelf.
Where another method or platform is the better answer for your laboratory, we say so.
Every figure, traceable.
- Ceveron t100 + Ceveron TGA RC High between-run CV: AUC 4.2%, peak 7.4%, lag 7.1% (19 replicate runs of normal control plasma) — Meihandoest 2021, Front Cardiovasc Med 8:717939 — PMC8459937.
- DOAC-level Spearman (n=559 patients): lag +0.80, peak −0.72, AUC −0.55 — Meihandoest 2021 — PMC8459937.
- ST Genesia inter-series CV <7%; Bland–Altman vs CAT peak +16.4 ± 13.2%, ETP +17.8 ± 11.9% — Foulon-Pinto 2021, Int J Lab Hematol 43:821 — PMID 33369212.
- Ceveron "CV<5% / ~20 min" [MFR] — manufacturer-stated figure, labelled as such.
- CAT / Thrombinoscope — the research reference method for thrombin generation.
TGA positioning: thrombin generation is a whole-curve global haemostasis assay used in specialist haemostasis laboratories. The evidence does not support routine DOAC monitoring (Meihandoest 2021); that limitation is evidential and applies only to DOAC drug-level monitoring, not to the assay class. TGA parameters are platform-specific — absolute peak and ETP are not interchangeable across instruments. The signature visual is illustrative and schematic, not pooled patient data.
Bringing TGA into the laboratory, or the reagents behind it?
Send a short note about the Ceveron TGA assay, the Ceveron analyser, or the parameter you are trying to interpret. We will reply with how we would approach it, what it would involve, and an honest quote, usually within two working days.