ITC VerifyNow System Platelet Reactivity Test User Manual

Page 87

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Page 83

14439.C 03/2013

Appendix - 11

VerifyNow System User Manual |

USA

Term

Description

Pouch

The white test device package.

Power indicator

When power is on, a green LED indicator on the lower left corner of the keypad

remains illuminated.

PRU

See P2Y12 reaction units.

ReoPro

Abciximab (trade name ReoPro

®

) is a platelet aggregation inhibitor mainly used

during and after coronary artery procedures like angioplasty to prevent thrombus

(blood clot) formation within the coronary artery. Its mechanism of action is

inhibition of the glycoprotein IIb/IIIa complex.

Sample well

A test device has of a sample well. The instrument automatically draws whole

blood into the test device from a sample collection tube in the sample well.

Staging well

Each test device has a staging well. The instrument heats the blood in the staging

well (except for the Aspirin test, which is heated in the mixing well).

Spot code

The spot code consists of printed black circles on the test device. It provides

information about the test device to determine which test is being performed and

the test device lot number.

Thienopyridine

Thienopyridines are a class of therapy that has significant antiplatelet effect

by inhibiting adenosine diphosphate (ADP)-mediated platelet activation.

Thienopyridines irreversibly inhibit ADP binding to the P2Y12 receptor on the

platelet surface. Clopidogrel (trade name Plavix

®

- clopidogrel bisulfate) and

prasugrel (trade name Effient

®

) is a thienopyridine.

Thromboxane

A2

A potent platelet agonist, thromboxane A2 is released by activated platelets and

acts to cause vasoconstriction and amplify the platelet recruitment by binding to

thromboxane receptors on the surface of circulating platelets.

TRAP

See iso-TRAP.

V1

The maximum vacuum level parameter reported during electronic quality control

diagnostics. See electronic quality control.

V2

The maximum leak rate parameter reported during electronic quality control

diagnostics. See electronic quality control.

VerifyNow

A platelet function test developed by Accumetrics. The VerifyNow system is a

whole blood, point-of-care test, which consists of a turbidimetric-based optical

detection instrument, single-use test devices, and associated quality controls.

Wet quality

control

WQC measures two levels of turbidimetric signal that verify the dynamic range of

the instrument. It verifies continued performance by checking that actual results

are within a standard range.

WQC

See wet quality control.

WQC kit

A kit of 6 wet quality controls (for Level 1 or 2 WQC). Controls are formulated at

clinically relevant levels, and are individually packaged in tubes (Level 1 and 2)

and vials (Level 2).

11.5

Software Icons

The icons represent actions and prompt the operator during the activities to configure the instrument,

test patient samples, perform quality control, and troubleshoot. The following is a complete list of all

screen icons and what each symbol represents:

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