Coag-Sense

Coag-Sense Connected Coagulation Lab Meter

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Procurement/Cost

Cost can range from $570 - $900.00, depending on the vendor.

Clinical Indication

Patients on warfarin therapy requiring regular INR checks, depending on the vendor.

Evidence Base

  • The aim of this study was to determine if the Coagsense point-of-care (POC) instrument provides more reliable INR measurements than Coagucheck XS POC in comparison to the Stago laboratory instrument in different disease states. Patients were invited to study if they had an of INR 2.0 to 5.0 and had a medical history of antiphospholipid syndrome, hypercoagulable disorder, autoimmune condition, peripheral vascular disease, mechanical heart valve, atrial fibrillation, or deep vein thrombosis/pulmonary embolism/cerebrovascular accident history. Seventy-seven patients were enrolled. Coagsense correlated well (92% of INRs within 20% of Stago, 64% of INRs within 0.2 of Stago, overall INR bias of 0.1 or 4%). Six patients had greater than 20% POC INR bias, which could have resulted in 4 warfarin dosing errors. The average Coagucheck XS INR bias (0.46-1.3 INR) increased with each 0.5 increase in laboratory INR, whereas Coagsense bias remained stable (0.1-0.25) as INR increased up to 4.3. Two patients correlated well on Coagucheck XS but not Coagsense. 

    Arline K, Rodriguez C, Sanchez K. Reliability of Point-Of-Care International Normalized Ratio Measurements in Various Patient Populations. Point of Care. 2020; 19(1):12-18.

Quality Control

FDA 510(k) clearance.

Technical Aspects/Integration

  • Portable meter that mechanically detects clot formation to measure INR with Bluetooth and WiFi connectivity, enabling INR value transmission to clinical team
  • WiFi and Bluetooth connectivity options send results to EHR systems, testing service providers, printers or POCT data management systems such as TELCOR or RALS

 

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