Accumetrics VerifyNow User manual

User Manual
3985 Sorrento Valley Blvd.
San Diego, California 92121 U.S.A.
Telephone (for US): 1-800-643-1640
Outside US: [phone]
Email address: [e-mail]
Website: www.accumetrics.com

VerifyNow System User Manual Page 2 14340.J
VerifyNow System User Manual
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Copyright © 2006 Accumetrics. All Rights Reserved. US Pat. D 409,758 and others pending.
Document No. 14340.J 2008-07-11

TABLE OF CONTENTS
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Table of Contents
About this Manual......................................................................................................6
Intended Use ..............................................................................................................6
Document Conventions....................................................................................6
1 Introduction ...................................................................................................9
1.1 Platelet Function Testing .....................................................................9
1.1.1 Aspirin Assay ...................................................................... 10
1.1.2 P2Y12 Assay....................................................................... 10
1.1.3 IIb/IIIa Assay .......................................................................11
1.2 Test Procedure .................................................................................. 12
2 Overview of System Components...............................................................13
2.1 Instrument .........................................................................................13
2.1.1 Assay Device Port and Cover..............................................14
2.1.2 Display Screen ....................................................................14
2.1.3 Icon Keys ............................................................................15
2.1.4 Keypad................................................................................15
2.1.5 Power Switch and Indicator .................................................15
2.1.6 Bar Code Scanner...............................................................16
2.1.7 Fan .....................................................................................16
2.1.8 Printer (Accessory).............................................................. 16
2.2 Assay Device..................................................................................... 16
2.2.1 Humidity Indicator ...............................................................17
2.2.2 Spot Code ...........................................................................17
2.3 Sample Collection Tubes ...................................................................18
2.4 Quality Control...................................................................................18
2.4.1 EQC Device and Storage Slot .............................................18
2.4.2 Assay Wet Quality Controls (WQC) ..................................... 19
3 Precautions..................................................................................................21
3.1 Safe Operating Procedures................................................................21
3.1.1 Sample Collection and Handling..........................................21
3.1.2 Instrument Operation...........................................................21
4 Reagent Storage and Handling ...................................................................23
4.1 Storage and Stability..........................................................................23
5 Quality Controls...........................................................................................25
5.1 Electronic Quality Control ..................................................................26
5.2 Wet Quality Control............................................................................29

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5.2.1 Level 1 WQC....................................................................... 29
5.2.2 Level 2 WQC....................................................................... 36
6 Patient Testing.............................................................................................43
6.1 Patient Preparation............................................................................43
6.2 Sample Collection.............................................................................. 43
6.2.1 Peripheral Samples .............................................................43
6.2.2 Indwelling Catheter..............................................................45
6.3 Sample Handling ...............................................................................46
6.4 Performing an Assay..........................................................................47
6.5 Interpreting Assay Results .................................................................54
6.5.1 Aspirin Assay Results..........................................................54
6.5.2 P2Y12 Assay Results ..........................................................54
6.5.3 IIb/IIIa Assay Results...........................................................55
6.6 Shutting down the Instrument ............................................................57
7 Retrieving Test Results and Performance Data ......................................... 59
7.1 Retrieving Patient Test Results..........................................................59
7.1.1 Patient Information Stored by Date/Time ............................. 59
7.1.2 Patient Information Stored by Patient ID .............................. 60
7.1.3 Assay Results Log...............................................................61
7.2 Retrieving Quality Control .................................................................. 62
7.2.1 Electronic Quality Control Results Log................................. 63
7.2.2 Wet Quality Control Results Log..........................................64
7.3 View Instrument Usage Log ...............................................................66
7.3.1 Instrument Usage Log .........................................................66
7.4 View Event Log.................................................................................. 67
7.4.1 Alarm and Error/Attention Log .............................................68
7.5 Transfer Network Data....................................................................... 69
8 Instrument Settings .....................................................................................71
8.1 Adjust Contrast..................................................................................71
8.2 Adjust Backlight.................................................................................72
8.3 Set the Date and Time.......................................................................73
8.4 Set Time Out .....................................................................................74
8.5 Enable Patient ID...............................................................................75
8.6 Set Operator ID and Password ..........................................................77
8.6.1 Operator Authority Log ........................................................78
8.7 Set EQC Frequency...........................................................................79

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8.8 Enable Printer....................................................................................80
8.9 Enable Network .................................................................................81
9 Cleaning and Maintenance ..........................................................................83
9.1 Use the Cleaning Device ...................................................................83
9.2 Clean Exterior Surfaces .....................................................................86
9.3 Replace the Fan Filter ....................................................................... 87
10 Troubleshooting ..........................................................................................89
10.1 Messages ..........................................................................................91
10.2 Attention, Error and Alarm Messages................................................ 93
10.3 Alarm Messages .............................................................................. 101
10.4 EQC Diagnostic Messages .............................................................. 102
11 Appendix .................................................................................................... 105
11.1 Technical Specifications .................................................................. 105
11.2 Explanation of Symbols ................................................................... 106
11.3 System Components........................................................................ 106
11.3.1 Spare Parts and Accessories............................................. 107
11.4 Glossary .......................................................................................... 108
11.5 Software Icons................................................................................. 116
11.6 Instrument Software – Assay and QC ..............................................119
11.7 Instrument Software – Settings and Logs ......................................... 120
11.8 VerifyNow Instrument Cleaning and Maintenance Schedule............. 121
11.9 Compliance with CLIA Control Requirements ................................... 123
11.9.1 Description of the VerifyNow System Control Measures..... 123
12 References ................................................................................................. 129
13 Index........................................................................................................... 131
Customer Support ................................................................................................. 135
Technical Support and Service .................................................................... 135
Ordering ...................................................................................................... 135

ABOUT THIS MANUAL
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About this Manual
This user manual is the place to begin if you are not familiar with the VerifyNow
Instrument. It includes information on the Aspirin, P2Y12, and IIb/IIIa assays. For
help with use of this instrument, please contact your laboratory supervisor or your
Accumetrics customer support representative.
Intended Use
The VerifyNow System is intended for use with human whole blood and VerifyNow
Assay Devices. The VerifyNow System should be operated by health care
professionals trained on use of the system and in accordance with institution policies
and procedures. An Accumetrics representative will assist your institution in the
installation of the system and training of operators.
Document Conventions
Several notations will be used consistently throughout this manual that require your
attention.
NOTE: A note is supplementary information or a recommendation for optimizing
performance.
CAUTION: A caution indicates a potential hazard that could cause
minor personal injury, and/or damage to equipment.
WARNING: A warning indicates a potential hazard that could cause
serious personal injury, and/or damage to equipment.
WARNING: This symbol indicates a potential biological hazard.

ABOUT THIS MANUAL
VerifyNow System User Manual Page 7 14340.J

INTRODUCTION - 1
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1 Introduction
Before you begin to use the VerifyNow System, it is appropriate to review the purpose of the test.
1.1 Platelet Function Testing
In general, platelet function testing measures the activity of platelets. Therapies that inhibit platelet
function have been used extensively to prevent the clinical complications of atherothrombosis.
Three classes of potent anti-platelet agents, including acetylsalicylic acid (aspirin), P2Y12
inhibitors (e.g. thienopyridines), and glycoprotein (GP) IIb/IIIa inhibitors, have been developed.
One method detects platelet activity by measuring in vitro platelet aggregation in a blood sample
exposed to specific agonists. This includes inhibition of platelet activity in response to anti-platelet
therapies. The VerifyNow system is a whole blood, point-of-care assay, which measures platelet-
induced aggregation as an increase in light transmittance. It consists of a turbidimetric-based
optical detection instrument, single-use assay devices, and associated quality controls ( Figure
1-1 ).
Figure 1-1 VerifyNow System
There are three types of VerifyNow assays: Aspirin, P2Y12, and IIb/IIIa (specifically for monitoring
of abciximab or eptifibatide). Each assay device contains a lyophilized preparation of human
fibrinogen coated beads and a platelet agonist. The platelet agonist varies by assay type. Each
assay is based upon the ability of GP IIb/IIIa receptors on activated platelets to bind to fibrinogen-
coated beads. When the activated platelets are exposed to the fibrinogen-coated beads,
agglutination occurs in proportion to the number of available platelet receptors. The instrument is
designed to measure this agglutination as an increase in light transmittance. The following sections
describe the mechanism of action for the three assays. Refer to Chapter 2, Overview of System
Components for more information on the instrument and consumables.
It should be noted that GP IIb/IIIa inhibitors such as abciximab (ReoPro®), eptifibatide (Integrilin®)
and tirofiban (Aggrastat®) interfere with the VerifyNow® Aspirin and P2Y12 assays. Patients who
have been treated with Glycoprotein IIb/IIIa inhibitor drugs should not be tested with the
VerifyNow® Aspirin or P2Y12 assays until platelet function has recovered. This time period is
approximately 14 days after discontinuation of drug administration for abciximab (ReoPro®) and up
to 48 hours for eptifibatide (Integrilin®) and tirofiban (Aggrastat®). The platelet function recovery
time varies among individuals and is longer for patients with renal dysfunction. Results obtained
from patients tested prior to platelet function recovery may be inconsistent and unreliable.
The following sections describe the mechanism of action for the three assays. Refer to Chapter 2,
Overview of System Components for more information on the instrument and consumables.

INTRODUCTION - 1
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1.1.1 Aspirin Assay
Acetylsalicylic acid (aspirin) has a significant antiplatelet effect by blocking the production
of thromboxane A2. A potent platelet agonist, thromboxane A2 is released by activated
platelets and acts to cause vasoconstriction and amplify platelet recruitment by binding to
thromboxane receptors on the surface of circulating platelets. In an activated platelet,
arachidonic acid is converted by cyclo-oxygenase (COX-1) to prostaglandin G 2 (PGG 2 )
and PGH 2 and then to thromboxane A2. Aspirin affects platelet function by irreversibly
inhibiting the cyclo-oxygenase (COX) activity of prostaglandin (PG) H-synthase, which in
turn blocks the metabolism of arachidonic acid to thromboxane A2 (TXA2). The primary
pharmacological effect of aspirin on platelets is to decrease the activation of the GP
IIb/IIIa receptor and activation of other platelets.
VerifyNow Aspirin assay is a qualitative test to aid in the detection of platelet dysfunction
due to aspirin ingestion in whole blood for the point-of-care or laboratory setting. The
assay incorporates the agonist arachidonic acid to activate platelets, and it measures
platelet function based upon the ability of activated platelets to bind to fibrinogen.
Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of
activated platelet GP IIb/IIIa receptors. If aspirin has produced the expected antiplatelet
effect, such aggregation will be reduced. The VerifyNow Aspirin assay reports the extent
of platelet aggregation as aspirin reaction units (ARUs). Given an ARU range of 350-700,
ARU values less than 550 are consistent with aspirin-induced inhibition of platelet
function, whereas values greater than or equal to 550 ARUs are not consistent with
aspirin-induced inhibition.
NOTE: The Aspirin assay is not for use in patients with underlying congenital
platelet abnormalities, patients with non-aspirin induced acquired platelet
abnormalities or in patients receiving non-aspirin anti-platelet agents. Refer to the
VerifyNow Aspirin package insert for information to be considered for patients
receiving NSAIDS. The Aspirin assay may be used in patients treated with
selective COX-2 inhibitors, e.g. celecoxib (Celebrex
®
).
1.1.2 P2Y12 Assay
P2Y12 inhibitors (e.g. thienopyridines) are a class of therapy that has significant
antiplatelet effect by inhibiting adenosine diphosphate (ADP)-mediated platelet activation.
Platelet activation by ADP plays a key role in the development of arterial thrombosis.
When secreted by activated platelets from storage granules, the ADP activates additional
platelets in circulation through two G protein-coupled P2 receptors, P2Y1 and P2Y12.
P2Y12 inhibitors irreversibly inhibit ADP binding to the P2Y12 receptor on the platelet
surface. By blocking this receptor, these agents interfere with additional platelet
activation, degranulation, and - by inhibiting the modification of the glycoprotein IIb/IIIa
receptor— aggregation.
The VerifyNow P2Y12 assay is a whole blood assay used in the laboratory or point of care
setting to measure P2Y12 receptor blockade. The assay incorporates the agonist ADP to
activate platelets. The VerifyNow P2Y12 assay also uses PGE1 to increase intraplatelet

INTRODUCTION - 1
VerifyNow System User Manual Page 11 14340.J
cAMP and reduce the contribution of the P2Y1 receptor on activation. This makes the
assay more specific for the effects of ADP on the P2Y12 receptor. It measures platelet
function based upon the ability of activated platelets to bind to fibrinogen. Fibrinogen-
coated microparticles aggregate in whole blood in proportion to the number of activated
platelet GP IIb/IIIa receptors; and if the P2Y12 inhibitor has produced the expected
antiplatelet effect, such aggregation will be reduced. The VerifyNow P2Y12 assay reports
the extent of platelet aggregation in P2Y12 reaction units (PRU) and percent inhibition.
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. Percent inhibition (%) is the percent change from baseline aggregation,
and is calculated from the PRU result and a base result. The base result is an
independent measurement based on the rate and extent of platelet aggregation from the
thrombin receptors, specifically the PAR-1 and PAR-4 receptors. To activate platelets, the
base channel incorporates the thrombin receptors’ activating peptide, (iso-TRAP) and
PAR-4 activating peptide (PAR-4 AP) for the PAR-1 and PAR-4 channels respectively.
High percent inhibition values are reported if the drug has produced the expected
antiplatelet effect.
NOTE: Refer to the VerifyNow P2Y12 package insert for information to be
considered for patients receiving anti-platelet agents.
1.1.3 IIb/IIIa Assay
The final common pathway to platelet aggregation involves binding of fibrinogen to the
glycoprotein (GP) receptor complex IIb/IIIa. The GP IIb/IIIa inhibitors block platelet
aggregation by preventing fibrinogen and other adhesion molecules (vWF) from binding to
the IIb/IIIa integrin on platelets. This in turn, interferes with the transformation of the
glycoprotein IIb/IIIa receptor complex, platelet activation, and eventual formation of a
stable platelet aggregate at the site of vascular wall injury.
The VerifyNow IIb/IIIa assay is a semi-quantitative, whole blood platelet function assay
used to measure GP IIb/IIIa receptor blockade in patients treated with abciximab or
eptifibatide. The assay incorporates the agonist thrombin receptor activating peptide (iso-
TRAP) to activate platelets, and it measures platelet function based upon the ability of
activated platelets to bind to fibrinogen. A synthetic peptide, iso-TRAP, serves as a
surrogate for thrombin and activates the platelet through the PAR-1 receptor. Fibrinogen-
coated beads aggregate in whole blood in proportion to the number of unblocked platelet
GP IIb/IIIa receptors. If IIb/IIIa inhibitors have produced the expected antiplatelet effect,
such aggregation will be reduced. The VerifyNow IIb/IIIa assay reports the extent of
platelet aggregation in platelet aggregation units (PAUs). Typically, a baseline sample can
be drawn prior to GP IIb/IIIa inhibitor administration, and the PAU result can be used as a
baseline reading for determining percent inhibition (when compared to a PAU result for a
sample drawn shortly after administering the agent). High percent inhibition values are
reported if the agent has produced the expected antiplatelet effect.
NOTE: The IIb/IIIa assay can detect platelet inhibition by tirofiban (Aggrastat
®
),
another intravenous GP IIb/IIIa inhibitor; therefore VerifyNow IIb/IIIa assay results
for these patients should be interpreted with care. A sample taken prior to

INTRODUCTION - 1
VerifyNow System User Manual Page 12 14340.J
abciximab or eptifibitide administration cannot be used to establish a “baseline” or
uninhibited result if a GP IIb/IIIa inhibitor was administered within the past 10 days.
1.2 Test Procedure
The VerifyNow system has been developed to provide a simple, accurate and reliable
means to measure platelet aggregation. This section provides an overview of the test
procedure.
Whole blood is collected from an indwelling catheter or from a peripheral site into a
vacuum collection tube. The tube is gently inverted five times and stored at room
temperature until use (up to 4 hrs, depending on the assay type). Refer to Chapter 6,
Patient Testing for more information on sample collection.
At the start of the test, the assay device is inserted into the instrument, and the sample
collection tube is gently inverted again several times and placed on the assay device,
requiring no cap removal, specimen preparation, or pipetting step. The instrument
automatically draws the sample from the vacuum collection tube into the assay device,
and proceeds with the analysis of the sample. The used device and tube are removed and
discarded. There is no blood handling required by the user. Results are reported within 2-
5 minutes, depending on the assay.
Refer to Chapter 5, Quality Controls and Chapter 6, Patient Testing for more information
on operating the instrument.

OVERVIEW OF SYSTEM COMPONENTS - 2
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2 Overview of S stem Components
The VerifyNow System consists of an instrument, disposable assay devices, sample
collection tubes, and quality control materials. This section provides a brief overview
of each component of the system, beginning with the instrument.
2.1 Instrument
The VerifyNow instrument provides the platform for an automated assay. It receives
an assay device and sample collection tube inserted into the assay device port.
Then, it automatically draws the blood sample into the assay device and proceeds
with the analysis of the sample. An operator specifies an automated activity and
retrieves test results using the display screen, keypad, and icon keys (Figure 2-1).
Figure 2-1 Instrument
Display Screen
Icon Keys
Keypad
Power Indicator
Assay Device Port
Cover
EQC Device
Storage Bay
Fan
Barcode Scanner

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2.1.1 Assay Device Port and Cover
The assay device port holds a VerifyNow assay device during the test. When seated
in the port, the assay device is aligned with optical detection components to measure
the agglutination of the sample using light transmittance through wells in the assay
device. When closed, the assay device port cover blocks ambient light in the room
from interfering with the test.
The assay device port is also equipped with a spot code scanner that scans
information on the assay device to determine which assay is being performed and
the assay device lot number.
2.1.2 Display Screen
All messages and instructions for the operator display on the screen. The display
screen provides information about each step in the test, the assay type, mode, as
well as the current date and time. Figure 2-2 highlights the common features of the
software screens.
Figure 2-2 Display Screen
Feature Description
Icons Icons are used to navigate through the steps in a test. Icons
display along the right side of the display screen and correspond
to an adjacent icon key. Selecting an icon key displays another
screen or directs the instrument to perform an action. Refer to the
Appendix for a description of each icon.
Prompt Most automated activities involve several steps and associated
screens. Instructions on what to do at the next step are provided
in the center of the display screen. In Figure 2-2, the image
prompts the operator to insert the sample collection tube.
Icon
Assay Type
Date and Time
Mode
Prompt

OVERVIEW OF SYSTEM COMPONENTS - 2
VerifyNow System User Manual Page 15 14340.J
Feature Description
Mode The software supports two different modes, depending on whether
the instrument is performing a quality test (QC mode) or
processing a patient sample (assay mode). In Figure 2-2, a
patient bed indicates an assay mode.
Assay Type Displays the quality control or sample test being performed
(Aspirin, P2Y12, or IIb/IIIa).
Date and Time Displays the current date and time.
NOTE: The instrument goes into “stand-by” mode when not in use for more than
five minutes. In stand-by mode, the screen will be blank and the green LED
indicator on the keypad will be illuminated. Pressing any key will return the
instrument to the VerifyNow instrument Main Menu. See section 9.4 to adjust this
setting.
2.1.3 Icon Keys
The four icon keys directly to the right of the display screen correspond to the
different icons displaying on the screen. Selecting an icon key displays another
screen or directs the instrument to perform an action.
2.1.4 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. They can
also be used to perform numeric entries. The right (→
→→
→) and left (←
←←
←) arrow keys move
the cursor as needed and work as toggle switches within certain screens. The Tab
key is used to move the cursor from field to field within certain screens.
2.1.5 Power Switch and Indicator
The power switch is located on the back of the instrument (“I” designates on, “O”
designates off). When the instrument is initially powered on, a series of internal
diagnostics occurs, which takes approximately 30 seconds. When power is on, a
green LED indicator on the lower left corner of the keypad remains illuminated.

OVERVIEW OF SYSTEM COMPONENTS - 2
VerifyNow System User Manual Page 16 14340.J
Figure 2-3 Power Switch
2.1.6 Bar Code Scanner
The bar code scanner is located on the left side of the instrument (Figure 2-4). When
activated, it illuminates a bar code light so that the bar code on the white assay
pouch can be presented by the user to be scanned, decodes the bar code, and
transmits the information to the instrument software. The instrument software
identifies the assay device expiration date and lot information. See section 6.4,
Procedure number 10 for additional information.
Figure 2-4 Bar Code Scanner and Fan
2.1.7 Fan
The instrument is equipped with an exterior fan vent next to the bar code scanner to
cool the internal electronic components. Avoid placing equipment adjacent to the fan
that obstructs airflow. Periodic cleaning of the fan filter may be performed to avoid
overheating of the instrument. See section 9.3 for fan filter replacement instructions.
2.1.8 Printer (Accessory)
The printer is an optional accessory to the instrument. The printer enables an
operator to print assay results, QC results, and instrument usage statistics. See
section 8.8 for instructions on enabling the printer.
2.2 Assa Device
The VerifyNow System uses disposable assay devices to conduct the test. There are
three types of assay devices relating to the appropriate platelet function test: Aspirin,
P2Y12, and GP IIb/IIIa inhibitors (specifically for monitoring abciximab or
Bar Code Scanner
Fan
Power Switch
Fuse Printer and Network
Connections

OVERVIEW OF SYSTEM COMPONENTS - 2
VerifyNow System User Manual Page 17 14340.J
eptifibatide). Assay devices are individually sealed in foil pouches and may be used
until the expiration date printed on each kit box and on the foil pouch.
Each single-use assay device consists of a sample well, staging well, and four
detection wells (Figure 2-5). The instrument automatically draws whole blood into the
assay device from a sample collection tube in the sample well. It then heats the
blood to 37°C for a period of time specific to each assay, and proceeds with the
analysis of the blood in the detection wells.
Figure 2-5 Assay Device
The detection wells of an assay device contain a lyophilized preparation of human
fibrinogen-coated beads and platelet agonist. Fibrinogen-coated beads bind to
available platelet receptors in the blood sample. When the activated platelets are
exposed to the fibrinogen-coated beads, agglutination occurs in proportion to the
number of available platelet receptors. The instrument measures this agglutination as
an increase in light transmittance through the detection wells.
2.2.1 Humidity Indicator
Each assay device contains a humidity indicator and is labeled with a unique spot
code. If the assay device has degraded due to prolonged exposure to room air, a
color change of the humidity indicator will be observed. If the humidity indicator is
pink on both sides, the assay device should be discarded.
2.2.2 Spot Code
Each assay device is labeled with a spot code. Upon insertion of the assay device
into the assay device port, the instrument automatically scans the spot code and
determines which assay is being performed, whether the particular lot has been used
previously, and if the lot expiration date has been reached.
Finger Grip
Spot
Code
Staging
Well
Sample or
WQC Tube
Detection
Wells
Humidity
Indicator
Sheath
Needle
Sample Well

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Assay devices are calibrated at the factory. No additional calibration is required by
the user. Information about calibration and the device expiration date is contained in
the bar code on the pouch of each assay device. The bar code must be scanned
whenever a new lot of assay devices is to be used.
NOTE: Handle assay devices as biohazardous material. Dispose of them in an
appropriate manner.
2.3 Sample Collection Tubes
The VerifyNow System uses whole blood collected in a partial-fill vacuum tube.
During the test, the tube is inserted onto the needle in the sample well of the assay
device - requiring no cap removal, specimen preparation, or pipetting step. There are
several types of sample collection tubes recommended for use with the system
(Table 2-1).
Table 2-1 Sample Collection Tubes
Collection Tube Description Assay
Greiner Bio-One Vacuette tube
(Greiner #454321)
Partial fill, 2 mL,
3.2% sodium
citrate. Blue top
Aspirin, P2Y12,
IIb/IIIa (only for use with ReoPro –
abciximab )
Greiner Bio-One Vacuette tube
(Greiner #454082)
Partial fill, 3 mL
lithium heparin.
Green top
IIb/IIIa - for use with Integrilin
( eptifibatide ) or ReoPro ( abciximab )
Greiner Bio-One Vacuette tube
(Greiner #454237)
Partial fill, 2 mL
lithium heparin.
Green top
IIb/IIIa - for use with Integrilin
( eptifibatide ) or ReoPro ( abciximab )
NOTE: The use of sample collection tubes other than those listed may adversely
affect assay results.
2.4 Qualit Control
Accumetrics rigorously tests each VerifyNow System to ensure it meets performance
standards. In addition, the system supports several types of quality controls to verify
continued performance during use.
2.4.1 EQC Device and Storage Slot
The Electronic Quality Control (EQC) is the primary quality control mechanism for the
VerifyNow instrument. It consists of a re-usable device that is inserted by the
operator into the assay port and is used to perform a comprehensive testing routine
that confirms instrument performance.

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VerifyNow System User Manual Page 19 14340.J
Figure 2-6 EQC Device
When not in use, the EQC device is kept in a storage bay on the right side of the
instrument.
NOTE: If the EQC device is lost or damaged, the instrument will be inoperable.
2.4.2 Assay Wet Quality Controls (WQC)
Assay Wet Quality Controls consist of an optically absorbent solution and a pellet
(Figure 2-7). When used in lieu of a patient sample during a test, it verifies continued
performance. Controls are formulated at clinically relevant levels, and are individually
packaged in tubes (Level 1 and 2) and vials (Level 2). They may be used until the
expiration date printed on each kit box and on the container label when stored at the
temperature indicated on the box.
Figure 2-7 Wet Quality Controls
Refer to Chapter 5, Quality Controls for more information on quality control tests and
detailed descriptions of the procedures.