Performance comparison of the PFA-200 and Anysis-200: Assessment of bleeding risk screening in cardiology patients

Abstract

BACKGROUND: Assessment of platelet function is important in the management of patients who are subject to operation as well as at potential risk of hemorrhagic complications. OBJECTIVE: This study aimed to evaluate a new platelet assays (Anysis-Epinephrine, Anysis-ADP) and to compare them with PFA-200 in cardiology visiting patients and inpatients. METHODS: Citrated blood samples were collected from 184 patients for ADP test and 163 patients for EPI test, who visited Korea University Guro Hospital with written consent. The PFA-200 assay gives a test result the closure time (CT) until the blood flow rate decreases to 10% of the initial value, whereas Anysis-200 assay does a blood flow migration distance (MD) until blood flow completely stops. According to the results of PFA closure time (CT), the tested samples were classified as either negative control or positive group. The measurements were simultaneously conducted with two devices and compared. RESULTS: The sensitivity and specificity of Anysis-200 C/EPI kit in comparison to PFA-200 C/EPI kit was 87.5% and 85.7%, respectively. Regarding C/ADP kit, the sensitivity and specificity of Anysis-200 was 96.9% and 87.5%, respectively. In addition, the sums of sensitivity and specificity are greater than 150% for both of EPI and ADP. Also, it was found that likelihood ratio and odd ratio for each assay provide useful additional information. Since the Cohen’s kappa coefficients value between the two devices was relatively high, the equivalence between the two devices was confirmed. CONCLUSIONS: Anysis-200, a novel platelet function analyzer has showed excellent agreements with PFA-200 with high agreement rates and precision. Anysis-200 assay would be useful in assessing bleeding risk management as well as abnormal platelet reactivity at point of care.