ITC VerifyNow System Platelet Reactivity Test User Manual

Page 85

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Page 81

14439.C 03/2013

Appendix - 11

VerifyNow System User Manual |

USA

Term

Description

Inhibitor,

glycoprotein

(GP) IIb/IIIa

GP IIb/IIIa inhibitors block platelet aggregation by preventing fibrinogen and other

adhesion molecules (vWF) from binding to the IIb/IIIa integrin on platelets.

Integrilin

Eptifibatide (trade name Integrilin

®

) 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.

iso-TRAP

Thrombin receptor activating peptide (iso-TRAP), a synthetic peptide, serves as a

surrogate for thrombin and activates the platelet through the PAR-1 receptor in the

and IIb/IIIa Test.

Keypad

The keypad contains 13 labeled keys located directly below the display screen.

The “0” through “9” keys are used to enter operator and patient identification

numbers, change the time and the date, and make selections from menu options.

Level 1

Wet quality control Level 1 is formulated at a clinically relevant level and is

representative of a sample with platelet inhibition. During Level 1 WQC, diluent is

used to verify continued performance by checking that actual results are within a

standard range. See also wet quality control.

Level 2

WQC Level 2 is formulated at a clinically relevant level, and is representative of

a sample with no platelet inhibition. During Level 2 WQC, a pink pellet is added

to the diluent to verify continued performance, by checking that actual results are

within a standard range. See also wet quality control.

Log

A running record of activity by the instrument. There are separate logs organized

by patient results, QC results, and error events.

Mask

The optical element parameter reported during electronic quality control

diagnostics. See electronic quality control.

Mode

The instrument supports two modes, depending on whether the instrument is

running a test or QC test.

Operator

identification

A feature that assigns a number and matching password number to each operator.

When enabled, identification is required to use the instrument.

P1

The maximum pressure level parameter reported during electronic quality control

diagnostics. See electronic quality control.

P2Y12 reaction

units

PRU. PRU reports the amount of ADP-mediated aggregation specific to the platelet

P2Y12 receptor, and is calculated as a function of the rate and extent of platelet

aggregation in the ADP channel.

P2Y12 receptor

The P2Y12 receptor is a G protein-coupled P2 receptor on the surface of the

platelet. Adenosine diphosphate (ADP) secreted from activated platelets results in

the further amplification by activating additional platelets in circulation via the P2Y1

and P2Y12 receptors.

PAR-1 receptor

PAR-1 is one of four protease-activated receptors (PAR) located on the surface of

platelets. Thrombin activates PAR-1 by cleavage of part of its extracellular domain.

Thrombin receptor activating peptide (iso-TRAP), a synthetic peptide, serves as a

surrogate for thrombin and activates the platelet through the PAR-1 receptor in the

PRUTest, P2Y12 and IIb/IIIa tests.

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