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Point-of-Care Testing Evaluated for Early Coagulopathy Diagnosis

By LabMedica International staff writers
Posted on 09 Jun 2021
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Image: The CoaguChek Pro II Coagulation Meter and CoaguChek PT Test Strips (Photo courtesy of Roche Diagnostics)
Image: The CoaguChek Pro II Coagulation Meter and CoaguChek PT Test Strips (Photo courtesy of Roche Diagnostics)
Hemorrhage and coagulopathy are particularly relevant complications and are often connected to injuries, surgical interventions, serious diseases, anticoagulant medication or pregnancy/delivery. Acute bleeding requires fast and targeted therapy and therefore, knowledge of the patient's potential to form a clot is crucial.

Treating bleeding complications, rapid hemostatic optimization (interventional, surgical, mechanical or medication) and targeted therapy are therapeutic goals and are therefore equivalent to those of coagulopathy treatment. The earlier a coagulopathy is diagnosed, the earlier a targeted therapy can be initiated. The international normalized ratio (INR) value is of particular importance for the diagnosis and therapy of coagulopathy.

Intensive Care Physicians at the University Hospital Frankfurt (Frankfurt, Germany) and their colleagues included in a study, one group that included hemorrhagic patients from the department of obstetrics (obstetric group = OG), and another group comprising patients admitted to the emergency department (emergency group = EG). The primary outcome measure was the difference between two INR results of one blood sample determined by point-of-care testing (POCT) and standard laboratory testing (SL).

After blood sampling, a drop of blood was applied immediately to the test stripe of the POCT device, CoaguChek Pro II (Roche Diagnostics GmbH, Mannheim, Germany). The CoaguChek Pro II is a portable device requiring an 8-μl sample volume. It measures the international normalized ratio (INR) based on an electrochemical reaction. Samples for SL analysis were sent to the central laboratory via a pneumatic dispatch system (EG) or personal-based transport (OG) for automated analysis with an ACL TOP 700 Hemostasis testing System, (Werfen GmbH, Munich, Germany) in combination with PT Re Combiplastin 2G reagents.

The team reported that INR results between POCT and SLA showed a high and significant correlation. POCT results were reported significantly more quickly (EG: 1.1 versus 39.6 minutes; OG: 2.0 versus 75 minutes) and required less time for analysis (EG: 0.3 versus 24.0 minutes; OG: 0.5 versus 45.0 minutes) compared to SLA. The time for transportation with the pneumatic tube was significantly shorter (8.0 versus 18.5 minutes) than with the personal-based transport system. The estimated blood loss was between 800 mL and 1300 mL.

The authors concluded that strip-based test systems may be suitable methods for the emergency diagnosis of hemorrhagic patients because their measurement results are available significantly more quickly and seem to support the use of point-of-care INR-devices to rule out pathological INR-values in bleeding patients. The test strip-based methods can be used as diagnostic elements in hemotherapy algorithms to implement fast and targeted hemotherapy that can positively impact the clinical outcomes of patients. The study was published on May 23, 2021 in the journal Practical Laboratory Medicine.

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