Table 2.
Diagnostic accuracy of Hemochron™ Signature Elite POCT for edoxaban
| Treatment threshold | Ideal cut-off | Specificity, % | Sensitivity, % | MP, % | LR | PPV, % | NPV, % |
|---|---|---|---|---|---|---|---|
| ≤30 ng/mL | lab-basedcalibratedanti-Xa activity ≤ 30 ng/mL | 100.0(91.7–100) | 94.0(82.5–98.4) | 0.0 | – | 100(90.6–100) | 94.7(84.5–98.6) |
| HC-INR ≤ 1.5 | 98.6(91.2–99.9) | 98.0(88.0–99.9) | 1.4 | 68.6(9.8–480.4) | 98.0(88.0–99.9) | 98.6(91.2–100) | |
| HC-ACT+ ≤ 115 s | 97.1(89.1–99.5) | 59.2(44.3–72.7) | 2.9 | 20.7(5.2–82.8) | 93.5(77.2–98.9) | 77.3(66.9–85.2) | |
| HC-ACT-LR ≤ 105 s | 97.1(89.1–99.5) | 38.3(24.9–53.6) | 2.3 | 13.4(3.3–55.1) | 90.0(66.9–98.2) | 70.1(59.8–78.8) | |
| HC-aPTT ≤ 68 s | 95.7(87.0–98.9) | 50.0(35.4–64.6) | 4.3 | 11.5(3.7–36.0) | 88.9(69.7–97.1) | 73.3(62.8–81.9) | |
| ≤50 ng/mL | lab-basedcalibratedanti-Xa activity ≤ 50 ng/mL | 100(90.6–100) | 89.5(77.8–95.6) | 0.0 | – | 100(91.3–100) | 88.7(76.3–95.3) |
| HC-INR ≤ 2.1 | 96.8(88.0–99.4) | 96.5(86.8–99.4) | 3.2 | 30.4(7.8–119.0) | 96.5(86.8–99.4) | 96.8(88.0–99.4) | |
| HC-ACT+ ≤ 120 s | 95.2(85.8–98.8) | 57.1(43.2–70.0) | 4.8 | 12.0(3.9–37.1) | 91.4(75.8–97.8) | 71.4(60.4–80.5) | |
| HC-ACT-LR ≤ 110 s | 95.2(85.8–98.8) | 48.1(34.5–62.0) | 4.8 | 10.1(3.2–31.6) | 89.7(71.5–97.3) | 68.2(57.3–77.5) | |
| HC-aPTT ≤ 68 s | 95.2(85.8–98.8) | 44.4(31.2–58.5) | 4.8 | 9.3(3.0–29.3) | 88.9(69.7–97.1) | 66.7(55.9–76.0) |
HC-INR, HC-ACT+, HC-ACT-LR, HC-aPTT = Hemochron™ Signature Elite point-of-care test system-based international normalized ratio, activated clotting time, and activated partial thromboplastin time; MP Misprediction percentage; LR Likelihood ratio; PPV Positive predictive value; NPV Negative predictive value. 95%-confidence intervals are reported in brackets wherever applicable