Establishing the clinical utility of integrated quasistatic acoustic tweezing thromboelastometry for blood coagulation analysis.

BACKGROUND: Rapid and accurate coagulation analysis is essential for managing critical care and surgical patients, patients with coagulation disorders, and patients with cardiovascular disease on anticoagulant therapy. Traditional assays often require large sample volumes, posing iatrogenic risks in vulnerable populations, including pediatric and elderly patients. Integrated quasistatic acoustic tweezing thromboelastometry (i-QATT) offers a comprehensive, noncontact assessment of coagulation using a 4- to 6-μL drop of blood that minimizes diagnostic errors associated with sample-container surface interactions.

OBJECTIVES: This study aims to assess the preliminary clinical utility of the i-QATT technique.

METHODS: Using blood samples from healthy volunteers and liver transplant patients, as well as control plasmas, we established the reference ranges for i-QATT coagulation parameters and validated them across several abnormal conditions, including single-factor deficiencies, abnormal fibrinogen levels, unfractionated heparin anticoagulation, and coagulopathy.

RESULTS: i-QATT identified coagulation abnormalities within 3 to 8 minutes. Its parameters showed strong correlations with gold-standard assay data, for example, activated partial thromboplastin time (r ≥ 0.81), international normalized ratio (r ≥ 0.74), thromboelastography (TEG) citrated kaolin channel parameters (R, K, α, and maximum width of TEG tracing [MA]; r ≥ 0.65), citrated rapid TEG (MA; r = 0.64), and TEG citrated functional fibrinogen (MA; r ≥ 0.64). i-QATT data demonstrated a near-linear response to unfractionated heparin concentrations spanning the prophylactic and therapeutic ranges (0-1 IU/mL; R2 = 0.98), and the anticoagulation reversal by heparinase was reliably detected. i-QATT accurately assessed the functional level of fibrinogen and platelet activity in normal and abnormal blood samples.

CONCLUSIONS: This study positions i-QATT as a highly sensitive, rapid, and ultra-low-volume alternative to conventional coagulation assays, with strong potential to transform point-of-care diagnostics across a wide range of clinical settings.