Download Verigene® System Technical Bulletin

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Document related concepts
no text concepts found
Transcript
®
Verigene RV+
Technical Bulletin
January 2011
Verigene® Respiratory Virus Plus
Nucleic Acid Test (RV+) on the
Verigene® System
Technical Bulletin
For in vitro Diagnostic Use
Page 1 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
SUBJECT
®
This communication is in regard to operation of the Verigene Respiratory Virus Plus Nucleic
Acid Test (RV+). This information is supplemental and clarifies the directions provided in the
®
package inserts for the RV+ and the User’s Manuals for the Verigene Processor SP and
®
Verigene Reader.
TABLE OF CONTENTS
INSTRUMENTS AND REAGENTS REQUIRED FOR RV+ ............................................................ 3
RECEIVING AND STORING THE TEST KIT COMPONENTS ....................................................... 3
MATERIALS NEEDED BUT NOT PROVIDED ............................................................................... 4
SAMPLE COLLECTION, HANDLING, AND STORAGE ................................................................. 4
PREPARING THE WORK AREA FOR TESTING ........................................................................... 4
PREPARING THE RV+ REAGENTS FOR LOADING .................................................................... 5
Preparing the Extraction Tray for Loading ............................................................................ 5
Preparing the Tip Holder Assembly for Loading .................................................................. 5
Preparing and Assembling the Amplification Tray for Loading .......................................... 6
Removing the Test Cartridge Cover ...................................................................................... 6
Settling the Test Cartridge Reagents .................................................................................... 7
STEP-BY-STEP LOADING OF THE CONSUMABLES INTO THE PROCESSOR SP .................. 8
Starting a Verigene® Session and Entering the Cartridge Barcode ................................ 11
ANALYZING RESULTS ................................................................................................................. 12
INTERPRETATION OF RESULTS................................................................................................ 13
RV+ INTERNAL CONTROLS ........................................................................................................ 14
PRINTING RESULTS .................................................................................................................... 15
COLLECTION OF RESIDUAL RNA (OPTIONAL) ........................................................................ 15
DISPOSAL OF CONSUMABLES AFTER TEST COMPLETION .................................................. 15
DAILY MAINTENANCE – END OF DAY ....................................................................................... 16
TIPS AND TROUBLESHOOTING ................................................................................................. 16
RV+ QUICK REFERENCE GUIDE ............................................................................................... 19
QUESTIONS OR CONCERNS ..................................................................................................... 20
Page 2 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
INSTRUMENTS AND REAGENTS REQUIRED FOR RV+
®
Verigene Instruments
®
• Verigene Reader (Cat. No. 10-0000-01)
®
• Verigene Processor SP with Amplification (Cat. No. 10-0000-07)
Test Kit Components
®
• Verigene RV+ Nucleic Acid Test Kit (Cat No. 20-005-020)
®
• Verigene RV+ Test Cartridges
®
• Verigene RV+ Extraction Trays
®
• Verigene RV+ Amplification Reagent Kit (Cat No. 20-012-020)
®
• Verigene RV+ Amplification Trays
RECEIVING AND STORING THE TEST KIT COMPONENTS
®
Reagents and consumables for the Verigene RV+ are shipped in two separate boxes:
®
Verigene RV+ Nucleic Acid Test Kit (Cat No. 20-005-020)
Reagents
Storage Conditions
Quantity per Box
Comments
Test Cartridge
2 – 8°C
20
Refrigerate Upon Arrival
Extraction Tray
2 – 8°C
20
Refrigerate Upon Arrival
Tip Holder Assembly
2 – 30°C
20
Shipped with Extraction
Trays
Do not freeze Extraction Trays or Test Cartridges.
®
Verigene RV+ Amplification Reagent Kit (Cat No. 20-012-020)
Reagents
Storage Conditions
Quantity per Box
Comments
Amplification Tray
– 20°C or colder
20
Freeze Upon Arrival
Amplification Tube
Room temperature
20
Shipped in Plastic Bag
with Amplification Trays
The Amplification Tray must remain frozen until the assay is performed. Do
not store in a frost-free freezer. If the user suspects that the Amplification Tray
did not remain frozen during shipping (i.e. no dry ice remaining in the shipping
package), immediately contact Nanosphere. Do not use the Amplification Trays
in question.
Page 3 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
MATERIALS NEEDED BUT NOT PROVIDED
Equipment
• -70°C Freezer
• -20°C Freezer
• 2 – 8°C Refrigerator
• Micro-pipette for 200 microliter volume
• Vortex mixer
• Mini-centrifuge
Consumables
• Sterile RNase/DNase-free micro-pipette tips with aerosol resistant filter
• Nylon or Rayon tipped nasopharyngeal swabs (Copan Innovation)
• Sani-Cloth Plus Germicidal Disposable Cloths (Professional Disposables Int’l No.
Q85084) or comparable lint free decontaminating wipe
• Polyurethane foam swabs (McMaster-Carr, #7074T52, or comparable)
Reagents
• Universal Transport Medium (Catalog number 330C, Copan Innovation) OR Micro Test
M5 Viral Transport Medium (Catalog number R12515; Remel, Inc.)
SAMPLE COLLECTION, HANDLING, AND STORAGE
Collecting and Transporting the Sample
• Training in sample collection and handling is highly recommended because of the
importance of specimen quality.
• Use Nylon or Rayon tipped nasopharyngeal swabs for sample collection.
• Place swab into Universal Transport Medium (3 mL). Break swab shaft and cap the tube.
• Transport human respiratory samples refrigerated at 2 – 8ºC. When transporting human
respiratory samples, ensure that all applicable regulations for the transport of etiologic
agents are met.
Storing the Sample
• Wipe down the outside of each sample tube with a lint-free decontaminating wipe when
the samples are received to avoid cross contamination.
• Store the nasopharyngeal swab samples refrigerated at 2 – 8 ºC for up to 72 hours
before processing.
• For longer term storage, store the samples frozen at – 70 ºC or below.
Preparing the Sample for Testing
• [Frozen samples only] Thaw samples at room temperature and thoroughly vortex each
sample for a minimum of 5 seconds.
• [Frozen samples only] Briefly centrifuge (e.g. 5 – 10 seconds) the sample in a minicentrifuge after mixing to ensure all of the sample fluid is at the bottom of the tube.
• Open and load one sample tube at a time to avoid cross contamination from tube to tube.
Improper collection, storage, or preparation of samples may negatively impact test
results and/or lead to cross contamination.
PREPARING THE WORK AREA FOR TESTING
•
Sanitize vortex mixers, centrifuges, pipettes, countertops, and any other equipment used
for sample processing with a lint-free decontaminating cloth before and after sample
preparation.
Page 4 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
PREPARING THE RV+ REAGENTS FOR LOADING
This section provides step by step instructions for performing the Verigene Respiratory Virus
Plus Nucleic Acid Test (RV+) on the Verigene System. Note: A quick overview is provided at
the end of this document.
Preparing the Extraction Tray for Loading
The Extraction Tray is a single use plastic tray filled with reagents required for the nucleic acid
extraction portion of the assay. The tray is stored at 2 – 8 ºC.
The reagents include magnetic beads, which settle during storage. Briefly
shake the tray to resuspend the magnetic beads prior to loading. Check for
resuspension by visually inspecting the well containing the beads. Following
resuspension, tap the tray on the counter to ensure that the reagents settle to
the bottom of each well.
Sample
Well
Residual
RNA
Well
Preparing the Tip Holder Assembly for Loading
The Tip Holder Assembly is a plastic holder that contains two Pipette Tips and a rubber Tip Seal.
Each Pipette Tip contains an O-ring on top. Tip Holder Assemblies are shipped in the same
container as Extraction Trays and are stored refrigerated or at room temperature (2 – 30 ºC).
O-Ring
Pipette
Tip
Tip
Seal
Before using the Tip Holder Assembly, check the top of each Pipette Tip for the
O-ring and check for the rubber Tip Seal between the tips. If either is missing,
replace with a new Tip Holder Assembly.
Page 5 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
Preparing and Assembling the Amplification Tray for Loading
The Amplification Tray is a single-use plastic tray filled with reagents required for the amplification
o
portion of the assay. The tray is stored at – 20 C or colder.
(A) The reagents within the Amplification Tray must be adequately thawed to ensure
homogeneity during the assay. Thaw the Amplification Tray at room temperature for 10 – 30
minutes before initiating a run. Visually inspect the tray for an orange reagent which moves
when agitated in liquid form.
Note: Only thaw Amplification Trays that will be used immediately to avoid enzyme
degradation. Do not re-freeze Amplification Trays.
(B) Once thawed, mix the reagents in the amplification tray by using a vortex mixer. Set the
vortex mixer to a setting between 5 and 6 and turn it on. Gently hold the amplification tray
against the vortex mixer for 10 seconds. Tap the tray on a solid surface to ensure that the
reagents return to the bottom of each well.
(C) The Amplification Tube is also required for the amplification process. It is stored at room
temperature. Remove the cap on the Amplification Tube prior to inserting the tube into the
Amplification Tray.
Note: Always use clean gloves during Amplification Tube insertion.
(D) Push the Amplification Tube into the Amplification Tray.
Amplification
Tube
Push Tube
into Tray
Push with
thumb to
ensure it is
all the way
down
Amplification
Tray
(E) After thawing, visual inspection, vortex mixing, and Amplification Tube insertion, tap the tray
gently on a solid surface to ensure that the reagents return to the bottom of each well.
Once the Amplification Tray has been removed from the freezer, begin test run
in the next 10 to 30 minutes or discard.
Wear clean gloves to insert the Amplification Tube.
Save the Amplification Tube cap to re-cap the Amplification Tube after
completion of the assay.
Removing the Test Cartridge Cover
®
The Verigene Test Cartridge contains the reagents required for the identification portion of the
assay, and it also contains a barcode for identification purposes. The cartridge is shipped and
stored with a cover to prevent reagent evaporation. It is stored at 2 – 8 ºC. The user must
remove the Test Cartridge’s cover prior to loading. Hold the cartridge on the handle side with the
left hand (see illustration below), and remove the cartridge cover with the right hand by bending
the cover away from the snaps. While applying pressure with the palm of the hand, pull up on the
handle to bend the cover for removal.
Page 6 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
Make sure that the valve plate (refer to image below) is not moved during cover
removal. The best way to avoid moving the valve plate is to grip the handle of
the Test Cartridge with your left hand as shown in the image on the right.
Do not remove the Test Cartridge cover until immediately prior to inserting the
Test Cartridge into the Processor SP.
Pull here to
remove cartridge
cover
Palm of hand on cover
and fingers pulling on
cartridge cover handle
Valve plate: Take
care to not move the
valve plate when
removing the
cartridge cover.
Settling the Test Cartridge Reagents
The user must “settle” the reagents in the cartridge before loading into the Verigene Processor
SP. The optimal method for “settling” the reagents is to hold the Test Cartridge’s reagent
container on the side opposite the handle and tap the reagent container’s barcode with your index
finger. When tapping the cartridge, allow the force of the tapping to move the cartridge and your
right hand. The tapping is more effective when the cartridge is held in the air so that it moves
slightly.
Page 7 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
STEP-BY-STEP LOADING OF THE CONSUMABLES INTO THE PROCESSOR SP
The following series of images can be used as a visual guide to loading each of the kit
components into the Verigene Processor SP.
(A) Image A shows an empty Verigene Processor SP. Open the Drawer Assembly by pressing
the black open/close button located on the front of the Verigene Processor SP. Open the
Drawer Clamp by pressing in the silver latch and lifting the Clamp prior to loading the
consumables.
Press to open the
Drawer Assembly
Press to lif t
Drawer Clamp
A
(B) Image B shows a properly loaded Extraction Tray. Prior to loading, shake the tray by
hand to re-disperse the magnetic beads before loading, and then tap the tray on the
counter to ensure the reagents return to the bottom of each well. The Sample Well is
located in the lower right hand corner of the open Drawer Assembly when loaded properly.
Press down on the corners of the tray to ensure it is level.
Extraction Tray
Sample Well
B
Page 8 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
(C) Image C shows a properly loaded Tip Holder Assembly. For orientation, there are two holes
on the deck of the Drawer Assembly that fit each Pipette Tip.
Tip Holder
Assembly
C
(D) Image D shows a properly loaded Amplification Tray and Amplification Tube. Prior to
loading, vortex the tray to mix reagents, then tap the tray on the counter to ensure the
reagents return to the bottom of each well before loading. Remember to insert the
Amplification Tube into the Amplification Tray before loading into the Processor SP.
The arrow in the image points to the location of the Amplification Tube which must be
inserted into the Tray. Note the location of the Amplification Tube and the corresponding
amplification well on the deck of the Drawer Assembly. The Amplification Tube can be used
to help guide the placement of the Amplification Tray in the proper orientation. When loaded
properly, the tray sits flat.
Amplif ication
Tray
D
Page 9 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
(E) Image E shows a closed Drawer Clamp over properly loaded trays and Tip Holder Assembly.
The Drawer Clamp will latch onto the Drawer Assembly when closed properly, and the
user will be unable to lift the Drawer Clamp without pressing in the silver latch. If the
Drawer Clamp is not latched properly, the Processor SP will display a message on the
information screen when the user attempts to close the Drawer Assembly. Try re-latching the
Drawer Clamp if this occurs.
Lower the
Drawer Clamp
E
(F) Image F shows the user loading an RV+ Test Cartridge into the Verigene Processor SP.
Prior to loading the Test Cartridge, the Test Cartridge barcode must be scanned into the
Verigene Reader and the Test Cartridge cover must be removed as described above. Once
the barcode is scanned and the cover is removed, the user inserts the Test Cartridge
into the Verigene Processor SP until it reaches a stopping point. If the Test Cartridge is
not inserted properly, the Processor SP will display a message on the information screen
when the user attempts to close the Drawer Assembly.
Test
Cartridge
F
Page 10 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
(G) After loading all of the consumables, load 200 microliters of sample into the Sample
Well of the Extraction Tray using a micropipette (refer to image below for Sample Well
location).
Sample
Well
Make sure the sample is pipetted into the bottom of the sample well before
closing the Drawer Assembly.
(H) Once the sample is added, close the Drawer Assembly by pressing the open/close button on
the front of the Processor to begin automated testing. The Processor will automatically verify
that each consumable is properly loaded and begin sample processing. The user can
monitor the assay status on the Verigene Processor SP information screen or on the
Verigene Reader by selecting the appropriate Processor.
®
Starting a Verigene Session and Entering the Cartridge Barcode
(A) Login to the Verigene Reader as a ‘user’.
(B) From the Menu Bar, SESSION tab, select Start New Session. The Session Setup window
will appear.
(C) Touch Session ID button and enter information by using the data entry keyboard. This can
be any unique identifier in a format defined by the laboratory. The operator ID is
automatically entered as the currently logged in operator.
(D) Touch the Processing option on the Navigation Bar at the bottom of the screen.
(E) Enter the Test Cartridge’s number by scanning the barcode using the barcode wand attached
to the Reader or keying in the cartridge number with the Reader’s keyboard. Enter the
sample number/ID by scanning or using the Reader’s keyboard. Press Yes to confirm the
sample ID (see image below).
Page 11 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
(F) In the subsequent dialogue box, de-select viruses or subtypes from the list to de-activate
results reporting for those targets. Press Yes to confirm (see image below). Note: once a
test run is started, results for de-selected targets cannot be retrieved. The cartridge is now
ready for loading as described in the section below.
Note: These steps can be repeated for additional cartridges; up to 60 cartridges can be
entered into a single session.
ANALYZING RESULTS
(A) Once the Processor SP and Reader indicate that the procedure is completed, remove
the Test Cartridge. The Verigene Processor SP will display “Procedure Done” on the front
of the instrument. The Reader will have an arrow in the Test Cartridge icon when the
Processor is finished.
(B) After removing the Test Cartridge from the Processor, orient the substrate on its side and
immediately remove the reagent container from the substrate holder. Keep the substrate
holder on its side until it is inserted into the Verigene Reader. Keeping the substrate on its
side allows any residual rinse reagent to flow away from the array part of the slide while
evaporating.
(C) Leave the substrate on its side on a clean, dust-free surface until the Reader is available for
analysis. Scan the barcode, remove the tape from the substrate, and insert the substrate into
the Reader for analysis.
Substrate Holder
Keep the substrate on its side during reagent pack removal, and leave it on its
side for 30-60 seconds after removal.
Page 12 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
INTERPRETATION OF RESULTS
The Verigene System software automatically determines the specimen results for Influenza A;
Influenza B; RSV A; RSV B; and Influenza A subtypes H1, H3, and 2009 H1N1. The test is
designed to provide a “Detected,” “Not Detected,” or “N/A” decision for each of the 7 targets
evaluated in each test sample. For example, the presence of Influenza A in a sample is
described as “Influenza A Detected” and the absence of RSV A in the same sample is described
as “RSV A Not Detected”. When Influenza A is Not Detected, the Influenza A subtype targets are
not analyzed and a “N/A” result is displayed for H1, H3, and 2009 H1N1.
An example of a detailed report can be found below. A normalized ratio of 0.85-1.00 indicates a
positive call and “Detected” is displayed alongside the virus.
Page 13 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
Failure of the system, cartridge or sample to produce a test result for one or more of the targets
can produce a “No Call” result. The descriptions of possible “No Call” results can be found in the
table below. In each case, the recommended recourse is to repeat the RV+ assay using the
same sample. If the repeat test generates “Detected,” “Not Detected,” or “N/A” results for each of
the 7 targets, the results are accepted. If the repeat test provides the same decision, the sample
is inadequate for testing on the RV+. A fresh specimen should be collected and tested.
No Call
Reason
No Call – INT CTL 1
Process Control 1 not detected
No Call – INT CTL 2
Process Control 2 not detected
No Call – INT CTL
IC1 and IC2 not detected
No Call – NO GRID
Reader unable to image Test
Substrate
No Call – VARIATION
No Call – NEG CTL
No Call – BKGD
High variability in the target-specific
signals
Target signal not sufficiently greater
than negative control signal
Target signal not sufficiently greater
than background
Potential Cause
Inhibition during target amplification
Processing and or target
amplification issues
Processing and/or target
amplification issues
-Protective silver tape not removed
from back of Test Substrate
-Test Substrate not properly seated
in black plastic Substrate Holder
Various
Various
Various
RV+ INTERNAL CONTROLS
Page 14 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
PRINTING RESULTS
The user can print a summary report containing all of the results within a session using the
following steps on the Verigene Reader:
(A) Using the Navigation bar at the bottom of the touch screen, select results.
(B) Under the menu tab located on the upper left of the touch screen, select “PRINT SESSION”
COLLECTION OF RESIDUAL RNA (OPTIONAL)
Residual RNA from test processing is collected from the Residual RNA Well in the Extraction
Tray (refer to image below).
1) Set a P200 or P1000 micro pipette to 200 µL.
2) Insert the pipette tip to the bottom of the Residual RNA Well on the Extraction Tray (see
diagram below) and draw up the residual nucleic acid from the well.
3) Transfer the RNA to a microcentrifuge tube or cryovial for transport and storage.
4) Store the RNA-containing vials at ≤ -70 °C.
Note: RNA is inherently unstable. Collect RNA as soon as possible after test processing
and place in cold storage (≤ -70 °C).
Sample
Well
Residual
RNA
Well
DISPOSAL OF CONSUMABLES AFTER TEST COMPLETION
Re-cap the Amplification Tube before removal to prevent cross contamination.
Treat all consumables as potentially infectious and dispose of them
accordingly.
Page 15 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
DAILY MAINTENANCE – END OF DAY
The user should do a daily maintenance at the end of the day.
(A) With a lint-free decontaminating wipe:
a. Wipe the heat block inside the Processor SP module’s drawer opening. The heat
block is the flat surface at the bottom of the opening. The wipe can be wrapped
around a swab to facilitate wiping.
b. Wipe the Amplification Tube Well and surrounding area on the drawer of the
Verigene Processor SP.
c.
Wipe the Drawer Clamp and arms in the Processor SP.
d. Wipe the outer surfaces of the Processor SP and Reader.
TIPS AND TROUBLESHOOTING
ISSUE
ACTION
CHANGING THE SAMPLE ID
The user can change the sample ID prior to
starting a run using the following steps:
1. Under the Menu tab, select Cancel
Test Cartridge.
2. Scan the barcode of the Test Cartridge
you want to cancel or enter the
barcode manually.
3. Re-scan the barcode of the Test
Cartridge and enter the appropriate
Sample ID.
TERMINATING A RUN
The user can terminate a run with the following
steps:
1. Under the menu tab, select Verigene
Processors on the touch screen to
display the status of each Processor.
2. Select the Processor of interest on the
touch screen.
3. Wait for the countdown to begin on the
Processor SP status screen, then
select Terminate on the touch screen
to end the run.
Page 16 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
ISSUE
ACTION
REVIEWING RESULTS FROM A PREVIOUS
The user can review results from a previous
VERIGENE SESSION
Verigene Session using the following steps:
1. Under the Sessions tab, select the
Session that you would like to review.
2. Touch the results option on the
navigation bar at the bottom of the
touch screen.
3. Select the sample of interest using the
touch screen to view the results.
THE PROCESSOR DOES NOT START
If the Processor fails to start automatically, it
AUTOMATICALLY AFTER THE DRAWER
will make a beeping sound to indicate a
ASSEMBLY IS CLOSED
consumable verification failure. The Processor
will display the verified components in the
“Ready to Start” screen. Under these
circumstances, the user must follow these
steps:
1. Open the Drawer Assembly to check
the consumable that could not be
verified.
2. Check to make sure the consumables
are properly positioned.
3. Re-close the Drawer Assembly.
4. The test should automatically begin. If
the Processor fails to start the test
automatically and the user is certain
that all components are loaded
correctly, the user can manually initiate
the assay (see below for instructions).
Page 17 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
ISSUE
ACTION
MANUALLY STARTING AN ASSAY IF THE
If a manual start is necessary, the user can
PROCESSOR DOES NOT START
initiate the assay using the Verigene Reader
AUTOMATICALLY
with the following steps:
1. Under the menu tab, select Verigene
Processors on the touch screen to
display the status of each Processor.
2. Find the Processor that did not start
when closed, and select start on the
touch screen.
3. The user will be asked to select a
cartridge identification number. Select
the barcode of the inserted cartridge.
THE READER IS UNABLE TO READ THE
The Reader will return a “NO CALL – NO
TEST SUBSTRATE (NO CALL – NO GRID)
GRID” is if the user forgets to remove the silver
tape from the back of the substrate or if the
Substrate Holder is not appropriately placed
into the Reader. The following steps can be
taken to check the Test Substrate:
1. Remove the Test Substrate from the
Reader.
2. Check to make sure the silver tape has
been removed from the back of the
substrate. If it is still attached, remove
the silver tape.
3. Under the Menu tab, select Enter
Barcode.
4. Re-scan cartridge barcode.
5. Re-insert the Substrate Holder into the
Verigene Reader until it reaches a
stopping point.
Note: Ensure that the glass slide is
positioned correctly within the
Substrate Holder.
Page 18 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
RV+ QUICK REFERENCE GUIDE
TEST SETUP
A. Remove the Amplification Tray from the freezer to thaw at room temperature (NOTE: Be sure
to start a test run within 10 – 30 minutes of removal from the freezer)
B. Remove Extraction Trays (with Tip Holders) and Test Cartridges from the refrigerator
C. Open the Drawer Assembly and lift the Drawer Clamp
D. EXTRACTION TRAY:
a. Shake the Extraction Tray to resuspend magnetic beads
b. Tap the Extraction Tray to settle reagents
c.
Insert the Extraction Tray into the Extraction Module
E. Insert the Tip Holder Assembly (double check for O-Rings and Tip Seal)
F. AMPLIFICATION TRAY:
a. Check the Amplification Tray after 10 minutes to ensure it is thawed
b. Vortex the Amplification Tray to mix the thawed reagents
c.
Tap the Amplification Tray to settle the reagents
d. Remove the cap of the Amplification Tube
e. Push the Amplification Tube into the Amplification Tray
f.
Insert the Amplification Tray/Tube into the Amplification Module
G. Lower and Latch the Drawer Clamp over the Trays
BEGIN RUN
H. TEST CARTRIDGE:
a. Use the Reader to set up a run:
i. Login
ii. Start new session or enter previous session using the Session Tab
iii. Input session ID – up to 60 cartridges/session
iv. Touch Processing Tab on navigation bar at bottom of touch screen
v. Scan the Test Cartridge using the barcode scanner
vi. Enter sample identification information
vii. Confirm/adjust assay targets to be reported with results
Sample
Well
b. Remove the cover from the top of the Test Cartridge
c.
Tap the Test Cartridge on the barcode to settle the
reagents
d. Insert the Test Cartridge into the Hybridization
Module
I.
LOAD SAMPLE – pipette 200 microliters of sample into
the bottom of the Sample Well
J.
Close the Drawer Assembly to begin test processing
K. Confirm countdown has started on the Processor SP before leaving the area
Page 19 of 20
For in vitro Diagnostic Use
10-0025-D
®
Verigene RV+
Technical Bulletin
January 2011
UPON COMPLETION OF RUN
L. Open the Drawer Assembly
M. Cap the Amplification Tube
N. Remove the Test Cartridges:
a. Remove the Test Cartridge from the Hybridization Module
b. Keeping the cartridge on its side, remove and discard the Reagent Pack
c.
Leave the Test Substrate on its side on a clean, dust-free surface for 30 – 60
seconds
O. Read the Test Cartridges:
a. Remove the silver tape from the back of the Test Substrate
b. Scan the barcode on the Test Substrate
c.
Insert the Test Substrate into the Reader for analysis
d. Confirm that a result other than ‘No Call – NO GRID’
has been generated
e. Dispose of used Test Substrate
•
COLLECT RESIDUAL RNA (OPTIONAL)
i. Using a standard pipette tip, pipette the
residual RNA from the Extraction Tray into the
appropriate tube
ii. Store the residual RNA tubes at -70 degrees C
P. Dispose of all consumables
Residual
RNA
Well
Sample
Well
DAILY MAINTENANCE – END OF DAY
(B) With a lint-free decontaminating wipe:
a. Wipe the heat block inside the Processor SP’s Hybridization Module
b. Wipe the Amplification Tube Well and surrounding area
c.
Wipe the Drawer Clamp and arms
d. Wipe the outer surfaces of the Processor SP and Reader
QUESTIONS OR CONCERNS
If you have questions or concerns regarding this bulletin, please contact your Nanosphere Clinical
Sales Representative or Nanosphere Product Support at 1-888-837-4436 or by email at
[email protected]
Page 20 of 20
For in vitro Diagnostic Use
10-0025-D