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A Novel Point-of-Care Whole Blood Coagulation Assay to Screen for Hemostatic Defects

S. Pourang1, M. Suster1, D. Maji1, S. Butala2, J. Nutt1, L. Nayak1,3, P. Mohseni1, S. Ahuja1,2

1Case Western Reserve University, Cleveland, United States, 2Rainbow Babies & Children's Hospital, Cleveland, United States, 3University Hospitals Cleveland Medical Center, Cleveland, United States

Abstract Number: PB0641

Meeting: ISTH 2020 Congress

Theme: Diagnostics and OMICs » Laboratory Diagnostics

Background: Screening coagulation assays (PT/PTT) have poor sensitivity and specificity for detection of hemostatic defects. We have developed a novel, point-of-care (POC), whole blood assay based on a dielectric microsensor (ClotChip) that provides global coagulation assessment in a miniaturized, portable measurement platform

Aims: To assess the ClotChip sensitivity to detect hemostatic defects

Methods: Patients (n=37) presenting with bleeding symptoms or with abnormal coagulation screening pre-operatively, and undergoing a bleeding disorder work-up, were enrolled. Blood samples were obtained by venipuncture in 3.2% sodium citrate. Coagulation was induced with CaCl2. ClotChip was based on the electronic technique of dielectric spectroscopy (DS) integrated into a disposable microfluidic channel with < 10 µL sample volume. ClotChip curves were calculated as variation in blood permittivity at 1MHz, and time to reach a peak in permittivity (Tpeak) was taken as coagulation time. Sensitivity and specificity of ClotChip were calculated for detection of a hemostatic defect

Results: ClotChip exhibited mean Tpeak of 435 ± 22 sec (mean ± SEM) for patients with clinically normal hemostatic function. Mean Tpeak for patients with a hemostatic dysfunction was 751 ± 159 sec and was significantly prolonged (P=0.002) compared to patients in the normal group. A receiver operator characteristic (ROC) curve (Fig. 1)

[ROC Curve]

was generated to determine the true-positive rate (sensitivity) and false-positive rate (100% – specificity) for ClotChip Tpeak to detect hemostatic dysfunction, and the area under the curve (AUC) for ClotChip Tpeak was 0.88. The sensitivity and specificity of ClotChip Tpeak with a threshold of 540 sec were determined as 78% and 93%, respectively (Table 1)

  Hemostatic Defect Present Hemostatic Defect Absent Total
ClotChip Abnormal 7 (True Positive) 2 (False Positive) 9
ClotChip Normal 2 (False Negative) 26 (True Negative) 28
Total 9 28 37

[Sensitivity and Specificity Results]

Conclusions: Our studies demonstrate a novel, microfluidic, dielectric sensor (ClotChip) was sensitive for detection of hemostatic defects. ClotChip has potential to fulfill an unmet clinical need as a POC tool to triage extensive work-up for bleeding symptoms or abnormal coagulation screening tests

To cite this abstract in AMA style:

Pourang S, Suster M, Maji D, Butala S, Nutt J, Nayak L, Mohseni P, Ahuja S. A Novel Point-of-Care Whole Blood Coagulation Assay to Screen for Hemostatic Defects [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/a-novel-point-of-care-whole-blood-coagulation-assay-to-screen-for-hemostatic-defects/. Accessed October 1, 2023.

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