Abstract
BACKGROUND: Rapid and accurate coagulation analysis is essential for managing critical care and surgical patients, patients with coagulation disorders, and cardiovascular patients on anticoagulant therapy. Traditional assays often require large sample volumes, posing iatrogenic risks in vulnerable populations, including pediatric and elderly patients. Integrated quasi-static acoustic tweezing thromboelastometry (i-QATTTM) offers a comprehensive, non-contact assessment of coagulation using a 4-6 microliter 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-QATTTM technique.
METHODS: Using blood samples from healthy volunteers and liver transplant patients as well as control plasmas, we established the reference ranges for i-QATTTM coagulation parameters and validated them across several abnormal conditions, including single-factor deficiencies, abnormal fibrinogen levels, unfractionated heparin (UFH) anticoagulation, and coagulopathy.
RESULTS: i-QATTTM identified coagulation abnormalities within 3-8 minutes. Its parameters showed strong correlations with gold-standard assay data, e.g., aPTT (r ≥ 0.81), INR (r ≥ 0.74), TEG CK channel parameters (R, K, α, MA; r ≥ 0.65), TEG CRT (MA, r = 0.64), and TEG CFF (MA, r ≥ 0.64). i-QATTTM data demonstrated a near-linear response to UFH concentrations spanning the prophylactic and therapeutic ranges (0-1 IU/mL, R2 = 0.98), and the anticoagulation reversal by heparinase was reliably detected. i-QATTTM accurately assessed the functional level of fibrinogen and platelet activity in normal and abnormal blood samples.
CONCLUSIONS: This study positions i-QATTTM 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.