Hemochron™ Signature Elite

Hemochron Signature Elite is a portable whole blood haemostasis monitoring system, designed for point-of-care testing. From the cardiovascular operating room (CVOR) to the cardiac catheterisation laboratory, haemostasis monitoring depends on fast, accurate and reproducible results — and this system delivers them through easy-to-use, easy-to-transport cartridge-based technology.

For critical patient management decisions, the system performs the activated clotting time (ACT+), the low-range activated clotting time (ACT-LR), the prothrombin time (PT/INR) and the activated partial thromboplastin time (APTT), directly at the patient’s bedside. A single system, with a broad test menu, standardises haemostasis testing across multiple clinical departments, maximising efficiency and compliance.

Fast, simple, standardised

• Fast — actionable results in approximately 4 minutes for ACT+, up to 2 times faster than other systems, thanks to RapidCount technology with real-time measurement.
• Simple — cartridge-based technology, with internal and automatic electronic quality control (EQC), and small dimensions for easy portability.
• Standardised — a single system with a broad test menu for POC haemostasis in various clinical contexts.

RapidCount technology and true end-point detection

Hemochron Signature Elite produces an ACT result in less time than traditional systems, through real-time measurement — which can speed up the initiation of the procedure. ACT+ testing allows a faster baseline result, beneficial for anticoagulated patients moving from the catheterisation laboratory to the CVOR.

The optical-mechanical method detects the true clot formation end-point, covering both primary and secondary haemostasis. The ACT+ and ACT-LR tests provide a “maximally activated” clotting time, which: supports current clinical practice guidelines, is less affected by hypothermia and artefacts, shortens the testing time and eliminates variability induced by haemodilution.

Safety, compliance and traceability

• Integrated barcode scanner — eliminates transcription errors and ensures an audit trail; scans cartridge and QC lot information, patient identification (PID) and operator identification (OID).
• Internal and automatic electronic quality control (EQC), with 2 levels.
• Lockouts for QC, cartridge and control expiry, plus operator tracking and lockout based on certification.
• Configuration Manager — ensures the appropriate test type is used in each department.

Test menu

Cartridge	Clinical use	Sample	Measurement range
ACT+	Moderate–high heparin (1–6 U/mL); cardiac surgery / CPB	Whole blood	68–1005 sec
ACT-LR	Low–moderate heparin (up to 2.5 U/mL); cardiac catheterisation, ECLS	Whole blood	65–400 sec
PT/INR	Monitoring of vitamin K antagonists (e.g. warfarin)	Whole blood (venous or capillary)	0.8–10 INR
Citrate PT	PT on citrated samples, testable up to 2 hours after collection	Citrated whole blood	0.8–10 INR
APTT	Monitoring of low-dose heparin (up to 1.5 U/mL)	Whole blood	50–345 WBS
Citrate APTT	APTT on citrated samples, testable up to 1 hour after collection	Citrated whole blood	50–345 WBS

PT/INR and APTT testing does not require sample preparation or centrifugation, and the analysis takes under 2 minutes — ideal for the fast flow of the Emergency Department.

Clinical applications

The system is used in a wide range of contexts: the operating room, the cardiac catheterisation laboratory, the Emergency Department (ED), the “stat” laboratory, radiology, interventional neuroradiology, Intensive Care (ICU), the electrophysiology laboratory and the anticoagulation clinic.

Technical specifications

Technology	Optical-mechanical, with clot end-point detection
Dimensions (L × W × H)	19 × 9.4 × 5 cm
Weight	0.53 kg
Test precision	≤10% CV for whole blood samples
Sample type	Fresh or citrated whole blood
Sample volume used	~15 µL (1–2 drop fill, 35–50 µL)
Data storage	Up to 600 patient samples and QC results
Battery	Rechargeable lithium-ion
Operating environment	15–30 °C, 20–85% RH (non-condensing)
EQC	2 levels of internal electronic control, automatic or manual
Calibration	Factory calibrated; requires no additional calibration by the user