Download Cholestech LDX® Cholesterol Analyzer Test

Cholestech LDX
Cholesterol Analyzer Test
®
Distributed by
The Cholestech LDX® Cholesterol Analyzer Test combines
enzymatic methodology and solid-phase technology to measure
total cholesterol, HDL cholesterol, triglycerides, and glucose.
Samples used for testing can be whole blood from a finger
stick (collected in a lithium heparin-coated capillary tube) or
venipuncture.The sample is applied to a Cholestech LDX cassette.
(For professional in vitro diagnostic use only.)
BENEFITS:
 Easy to use; fast & reliable results
 Results in 5 minutes
 Single-use disposable cassettes
 Room temperature storage for 30 days
 FDA-Cleared / CLIA Waived
*
*Note: The High Sensitivity C-Reactive Protein Tests
are Moderately Complex and are not CLIA Waived.
Ordering Information:
Product Description
Cholestech LDX Analyzer System (1 system)
Cholestech Total Cholesterol Cassette (10 cassettes)
Cholestech TC HDL Tests (10 cassettes)
Cholestech TC GLU Tests (10 cassettes)
Cholestech TC HDL GLU Tests (10 cassettes)
Cholestech Lipid Profile GLU (10 cassettes)
Cholestech Lipid Profile Tests (10 cassettes)
Cholestech Thermal Label Printer (1 printer)
Cholestech Thermal Printer Labels (1 roll)
Cholestech LDX ALT/AST Tests (10 cassettes)
High Sensitivity C-Reactive Protein Tests* (10 tests) *Moderately Complex
Cholestech ROM Upgrade Kit (1 kit)
Catalog #
CTH-10-959
CTH-10-986
CTH-10-987
CTH-10-988
CTH-10-990
CTH-10-991
CTH-10-989
CTH-11-781
CTH-11-785
CTH-12-788
CTH-12-807
CTH-13-184
 11578 Sorrento Valley Road, Suite 25/26, San Diego, CA 92121  tel (858) 481-5031 
toll free (888) 882-7739  e-mail: [email protected]
fax
(801) 720-7568
CPT Code Reimbursement Information
Reimbursement Information:
CPT Code #
National Limit Amount
Lipid Profile, waived procedure (Total Cholesterol, HDL Cholesterol and Triglycerides)
Option A:
80061QW (Lipid Panel, waived procedure)
$18.72
Option B:
82465QW (Total Cholesterol, waived method)
$6.08
83718QW (HDL Cholesterol, waived method)
$11.44
84478QW (Triglycerides, waived method)
$8.04
Lipid Profile and Glucose, waived procedure (Total Cholesterol, HDL Cholesterol,Triglycerides and Glucose)
Option A:
80061QW (Lipid Panel, waived procedure)
$18.72
82947QW (Glucose, quantitative, waived procedure)
82465QW (Total Cholesterol, waived method)
83718QW (HDL Cholesterol, waived method)
84478QW (Triglycerides, waived method)
82947QW (Glucose, quantitative waived procedure)
$5.48
$6.08
$11.44
$8.04
$5.48
Total Cholesterol, HDL Cholesterol and Triglycerides
82465QW (Total Cholesterol, waived method)
83718QW (HDL Cholesterol, waived method)
82947QW (Glucose, quantitative, waived procedure)
$6.64
$11.44
$5.48
Total Cholesterol, HDL Cholesterol
82465QW (Total Cholesterol, waived method)
83718QW (HDL Cholesterol, waived method)
$6.08
$11.44
Total Cholesterol and Glucose
82465QW (Total Cholesterol, waived method)
82947QW (Glucose, quantitative, waived procedure)
$6.08
$5.48
Total Cholesterol
82465QW (Total Cholesterol, waived method)
$6.08
Option B:
Glucose
82947QW (Glucose, quantitative)
82950QW (Glucose Post Dose, includes glucose)
82951QW (Glucose Tolerance Test (3 tests)
82952QW (Glucose Tolerance Test - each additional test beyond 3 tests)
$5.48
$6.64
$17.99
$3.50
DISCLAIMER – The CPT information contained in this document is provided as representative examples of reimbursement in this category. It is intended to assist providers in accurately
obtaining reimbursement for health care services. It is not intended to increase or maximize reimbursement by any payor. Providers should consult their payor organizations with regard to local
reimbursement policies. The information provided in this document is for information purposes only and represents no statement, promise or guarantee by CLIAwaivedTM Inc. All CPT codes
are supplied for information purposes only and represent no statement; promise or guarantee by CLIAwaivedTM Inc. that these codes will be appropriate or that reimbursement will be made.
CPT codes and descriptions are copyrights of the American Medical Associations. CPT does not include fee schedules, relative values or related ratings. The source for this information is
the Center for Medicare and Medicaid Services. The content provided by the Center for Medicare and Medicaid Services is updated frequently. It is the responsibility of the service provider to
confirm the appropriate coding required by their local Medicare carriers, fiscal intermediaries and commercial payors. All product information and prices are subject to change without notice
at any time. Please call our office before ordering to verify current prices.
 11578 Sorrento Valley Road, Suite 25/26, San Diego, CA 92121  tel (858) 481-5031 
toll free (888) 882-7739  e-mail: [email protected]
fax
(801) 720-7568
CHO-04-046 LDXQRG_1
12/21/04
3:52 PM
Page 2
Cholestech LDX Cholesterol Analyzer Test Setup Instructions
®
Setup
Test Pr
1
Take the time to examine and familiarize yourself with the contents of the Cholestech LDX System.
the Cholestech LDX
1 Connecting
to the Printer
A
Before starting to test, press and
hold STOP to enter the Configuration
Menu and select options for language,
units, sample type, printer, risk
assessment, date, and time.
A
B
B
Plug the printer power supply A
into the printer and the wall or
power strip. Connect the end of
the printer cable B , labeled
“To Printer”
, to the printer.
2 Configuration Menu
Plug the power supply A into
the Cholestech LDX and the wall
or power strip. Insert the end of
the white printer cable B ,
labeled “To Cholestech LDX”,
into the Analyzer.
4 Running Controls
Run the Optics Check Cassette
Cholestech Level 1 and 2 Controls
Press the RUN button.
The drawer will open.
Place the Optics Check
Cassette into the cassette
drawer. Press the RUN
button again to close
the drawer.
Controls must be run
following manufacturer’s
recommendations.
Controls must be at room
temperature before
testing. Verify that the lot
number on the control vial
and the assay sheet are the same. Mix each
vial by gently inverting 7–8 times immediately
before use. Store controls in the refrigerator when
not in use.
Record Results
Check to see that the four
Optics Check Results
numbers are within the
acceptable range printed
on the Optics Check
Cassette. Record the
results on the Optics
Check Log. If the
numbers are outside the
range, the Analyzer will be temporarily disabled until
another optics check is run that falls within range.
The Optics Check Cassette is used to check the
optical system of the Analyzer. Run the Optics Check
Cassette: once each day before patient samples are
tested and after the Cholestech LDX has been moved
or serviced.
Press the RUN but
drawer will open, a
Load cassette
The DATA button allows you to select
choices for each of the menu items
in the Configuration Menu. The RUN
button enters your choices and
advances you to the next menu item.
3 Optics Check
Open the Draw
5
Insert the Cas
Immediately place
drawer with the bla
and the brown mag
Testing QC Material
FAQ
Use the MiniPet™ Pipette
and tips to measure and
dispense the control
sample into the cassette.
Place the cassette in the
drawer immediately and
press RUN. Record results
on the Quality Control Log. Results must be within
established ranges before patient samples can
be tested.
Frequently
How do I get a
Even though the Ch
must have a CLIA
department of hea
Technical Service c
application.
Remember: The Ch
 11578 Sorrento Valley Road, Suite 25/26, San Diego, CA 92121  tel (858) 481-5031 
toll free (888) 882-7739  e-mail: [email protected]
fax
(801) 720-7568
Cholestech LDX® Cholesterol Analyzer Test Procedure Instructions
4:523:52
PM PM
PagePage
2 2
Test Procedure
the Drawer
1theOpen
miliarize
d familiarize
yourself
yourself
with with
the contents
contents
of theof Cholestech
the Cholestech
LDX LDX
System.
System.
X System.
Menu
olestech
tech LDXLDX
Menu
Menu
2 Configuration
2 Configuration
ess and
nfiguration
r language,
r, risk
me.A A
BeforeBefore
starting
starting
to test,
to press
test, press
and and
hold STOP
hold STOP
to enter
to enter
the Configuration
the Configuration
Press the RUN button on the Analyzer. The cassette
MenuMenu
and select
and select
options
options
for language,
for language,
drawer will open, and the screen will display:
units,units,
sample
sample
type, type,
printer,
printer,
risk risk
Load cassette and press RUN.
assessment,
assessment,
date, date,
and time.
and time.
B B
ou to select
enu items
The DATA
The DATA
buttonbutton
allowsallows
you toyou
select
to select
Thethe
RUN
Plug
Plug
power
the power
supplysupply
Au.
A into
A into
choices
choices
for each
for each
of theofmenu
the menu
itemsitems
stheand
Cholestech
the Cholestech
LDX and
LDXthe
andwall
the wall
Insert
the
Cassette
in the
inConfiguration
the
Configuration
Menu.Menu.
The RUN
The RUN
menu
item.
or
or
power
strip. strip.
InsertInsert
the end
theofend of
f power
buttonbutton
enters
enters
your
choices
your choices
and and
Dispense
the
Sample
B, B,
the white
the white
printer
printer
cablecable
advances
advances
you toyou
thetonext
the menu
next menu
item. item.
labeled
labeled
“To Cholestech
“To Cholestech
LDX”, LDX”,
into the
intoAnalyzer.
the Analyzer.
Perform
Perform
Perform
a Fingerstick
aaFingerstick
Fingerstick
edure
ure
dure
Test
TestProcedure
Procedure
Perform a Fingerstick
2 Open
the the
Drawer
Drawer
1 1 Open
5
4
2 22
ck
Collect
the Sample
Controls
Controls
4 Running
4 3Running
esette
Cholestech
Cholestech
LevelLevel
1 and12and
Controls
2 Controls
After cleaning the selected site with alcohol and
drying it thoroughly, firmly prick the site with a lancet.
PressPress
the RUN
the button
RUN button
on theonAnalyzer.
the Analyzer.
The cassette
The cassette
Gently squeeze the finger to obtain a large drop of
drawer
drawer
will open,
will open,
and the
andscreen
the screen
will display:
will display:
blood. Wipe off the first large drop of blood.
LoadLoad
cassette
cassette
and and
press
press
RUN.RUN.
6 Begin the Test
the the
Cassette
Cassette
5 5InsertInsert
Collect
Collect
thethe
Sample
theSample
Sample
3 33Collect
4 Dispense the Sample
Controls
Controls
must must
be runbe place
run the cassette into the Analyzer
Immediately
following
following
manufacturer’s
manufacturer’s
drawer
with
the
black
toward
n until a large drop of blood
Place the end of
the reaction
capillarybar
tube
into the Analyzer
recommendations.
recommendations.
and
the
brownwell
magnetic
stripe on
the
right.
horizontally by the end withControls
the
sample
and
dispense
the
sample
Controls
must must
be atbe
room
at room
op of blood without touchingtemperature
by
pushing
down
on
the
plunger.
Keep
temperature
beforebefore
zer.
nalyzer.
Analyzer.
The
cassette
The
The
cassette
AfterAfter
cleaning
Aftercassette
cleaning
cleaning
the level
selected
the
theselected
selected
site
with
sitewith
alcohol
with
alcohol
alcohol
and and
and
ube
within
10cassette
seconds. testing.
the
after
the site
sample
has
testing.
Verify
Verify
that the
thatlotthe lot
en
ill
een
display:
will
will
display:
display:
drying
drying
drying
it
thoroughly,
ititthoroughly,
thoroughly,
firmlyfirmly
firmly
prickprick
the
pricksite
the
thewith
site
sitewith
awith
lancet.
aalancet.
lancet.
each
nter the capillary tube. number
applied.
number
onbeen
theoncontrol
the control
vial vial
ress
ess
RUN.
RUN.
RUN.
Gently
Gently
Gently
squeeze
squeeze
squeeze
the finger
the
thefinger
finger
to obtain
totoobtain
obtain
a large
aalarge
drop
largedrop
ofdropofof
diately
and
the
and
assay
the
assay
sheet
sheet
are
the
are
same.
the
same.
Mix
each
Mix
each
site when
with alcohol and
Squeeze
the
gently
again
a large drop of blood
blood.
blood.
blood.
WipeWipe
off
Wipe
the
off
offfirst
the
thefinger
first
large
firstlarge
large
dropdrop
of
drop
blood.
ofofuntil
blood.
blood.
ator
Print
the
Results
gently
by
gently
inverting
inverting
7–8 times
7–8capillary
times
immediately
immediately
rick the site with a lancet.vial byvial
forms.
Hold
the
tube horizontally by the end with
before
before
use.
Store
use.
Store
controls
controls
in
the
in
refrigerator
the
refrigerator
when
when
obtain
a large drop of
the plunger. Touch it to the drop of blood without touching
ptics
heck Check
ResultsResults
not innot
use.
in use. the skin. Fill the capillary tube within 10 seconds.
ge drop of blood.
Begin
Begin
Begin
thethe
Test
theTest
Test
not allow any bubbles to enter the capillary tube.
Testing
Testing
QC Material
QC Do
Material
8
6 66
Collect the Sample
3Perform
a Fingerstick
a Fingerstick
2 2 Perform
the
4 Dispense
Collect
Collect
the th
S
33
Squeeze the finger gently again until a large drop of blood
forms. Hold the capillary tube horizontally by the end with
After After
cleaning
cleaning
the selected
the selected
site with
site alcohol
with alcohol
and and
the plunger. Touch it to the drop of blood without touching
dryingdrying
it thoroughly,
it thoroughly,
firmlyfirmly
prick prick
the site
thewith
site awith
lancet.
a lancet.
the skin. Fill the capillary tube within 10 seconds.
GentlyGently
squeeze
squeeze
the finger
the finger
to obtain
to obtain
a large
a large
drop of
drop of
Do not allow any bubbles to enter the capillary tube.
blood.blood.
Wipe Wipe
off the
offfirst
the large
first large
drop drop
of blood.
of blood.
7 View the Results
the the
TestTest
6 6BeginBegin
Dispense
Dispense
thethe
Sample
theSample
Sample
4 44Dispense
Press RUN. The drawer will close. When the test is
finished, the Analyzer will beep and the drawer will
Immediately
Immediately
placeplace
the cassette
the cassette
into the
intoAnalyzer
the Analyzer
open. Put everything that touched the blood sample
drawer
drawer
with the
withblack
the black
reaction
reaction
bar toward
bar toward
the Analyzer
the Analyzer
into a biohazardous waste container.
and the
andbrown
the brown
magnetic
magnetic
stripestripe
on theonright.
the right.
Squeeze
Squeeze
Squeeze
the finger
the
thefinger
finger
gentlygently
gently
againagain
again
untiluntil
auntil
large
aalarge
drop
largedrop
ofdrop
blood
ofofblood
blood
forms.
forms.
forms.
Hold Hold
the
Hold
capillary
the
thecapillary
capillary
tube tube
horizontally
tubehorizontally
horizontally
by thebyby
end
the
thewith
end
endwith
with
the plunger.
the
theplunger.
plunger.
TouchTouch
Touch
it to itthe
ittoto
drop
the
thedrop
ofdrop
blood
ofofblood
blood
without
without
without
touching
touching
touching
Place
the
end
ofcapillary
the
capillary
tube
the skin.
the
the
skin.
Fill
skin.
the
Fill
Fill
capillary
the
the
capillary
tubetube
within
tube
within
within
10into
seconds.
1010seconds.
seconds.
the
sample
well
and
sample
Do not
DoDo
allow
not
not
allow
allow
any bubbles
any
anybubbles
bubbles
to dispense
enter
totoenter
enter
thethe
capillary
the
the
capillary
capillary
tube.tube.
tube.
by pushing down on the plunger. Keep
the
level after the sample has
ViewView
View
thecassette
the
Results
theResults
Results
been applied.
Place the end of th
the sample well an
Squeeze
Squeeze
the finger
the f
by pushing down o
forms.forms.
Hold the
Holdcath
the cassette level
the plunger.
the plunger.
TouchT
been applied.
the skin.
the skin.
Fill the
Fill
Do notDoallow
not allow
any b
8 Print the Resu
the the
Res
7 7ViewView
Press the DATA button on the Analyzer once or
The results will pri
twice (depending on the test cassette) to view
PressPress
RUN. RUN.
The drawer
The drawer
will close.
will close.
WhenWhen
the test
theistest is
PressPress
the DATA
the DA
bu
remaining results.
finished,
finished,
the Analyzer
the Analyzer
will beep
will beep
and the
anddrawer
the drawer
will will
twicetwice
(depending
(depen
open.open.
Put everything
Put everything
that touched
that touched
the blood
the blood
sample
sample
remaining
remaining
results.
re
Place
Place
the
end
the
of
end
end
theofofcapillary
the
thecapillary
capillary
tube
tube
into
tubeinto
into
intoPlace
ainto
biohazardous
athe
biohazardous
waste
waste
container.
container.
the reference
sample
the
thesample
sample
well
well
and
well
and
dispense
anddispense
dispense
the
thesample
sampleof the testing procedure. For more informa
This
guide
provides
a the
briefsample
summary
by pushing
bybyinserts,
pushing
pushing
down
down
down
onCholestech
the
ononplunger.
the
theplunger.
plunger.
Keep
KeepUser Manual, or the Cholestech LDX System T
product
the
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System
This reference
This reference
guideguid
pro
the cassette
the
thecassette
cassette
levellevel
after
levelafter
the
aftersample
the
thesample
sample
has has
has
product
product
inserts,
inserts,
the Cho
the
beenbeen
applied.
beenapplied.
applied.
Print
thethe
Results
the
7 77
8 8How
8PrintPrint
often
do Results
IResults
have to run the controls?
If you are testing under CLIA-waived status, you must follow the manufacturer’s
recomme
HowHow
often
often
do
Ido
ha
Use the
UseMiniPet
the MiniPet
Pipette
Pipette
controls. Cholestech recommends that you run controls:
View
the
Results
Print
the
Results
FAQ
FAQ
If
you
If
are
you
testing
are
testing
underu
7
8
and tips
andFrequently
totips
measure
to measure
and andasked questions about the use of the Cholestech LDX
• With each new shipment of cassettes (even if cassettes are from the same lot previous
controls.
controls.
Cholestech
Cholestec
reco
FAQ
™
™
Frequently
Frequently
asked
asked
questions
questions
about
about
thethe
useuse
of the
of the
Cholestech
Cholestech
LDXLDX
dispense
dispense
the control
the control
• With each new lot of cassettes.
• With• each
With each
new shipme
new sh
sample
sample
into the
intocassette.
the cassette.
• As otherwise required by your laboratory’s standard quality control procedures.
• With• each
With each
new lot
newofloc
PlacePlace
the cassette
the cassette
in thein the
porarily
y disabled
disabled
until until
• If you are not running the Cholestech LDX under CLIA-waived status, or if your local or stat
How
do Iand
getand
a CLIA Certificate of Waiver?
• As •otherwise
As otherwise
required
requ
drawer
drawer
immediately
immediately
within
falls within
range.range.
frequent testing of quality control material, then quality control must be performed in com
t be within
Even though the Cholestech LDX is a “CLIA-waived” test system, each
laboratory
or testing
site
using
the Cholestech
LDX
• If you
• Ifare
younot
arerunning
not runn
t
How
How
do Ido
get
I get
a CLIA
a CLIA
Certificate
Certificate
of Waiver?
of Waiver?
presspress
RUN.The
RUN.
Record
Record
results
Analyzer once or
results
willresults
print when the test is finished.
must have a CLIA Certificate of Waiver before starting testing. To obtain a Certificate of Waiver, call your state
frequent
frequent
testing
testing
of quao
les
can
sed
check
to
check
theto the
on theonQuality
the
Quality
Control
Control
Log.
Results
Log.orResults
must must
be within
be withinService (1.800 733.0404)
Even Even
though
though
the
Cholestech
the Cholestech
LDX HCFA-116).
isLDX
a “CLIA-waived”
is a “CLIA-waived”
test system,
test system,
each
each
laboratory
laboratory
orItesting
or testing
site
using
site
using
the Cholestech
the Cholestech
LDX LDX
cassette)
view
How
should
store
my
cassettes?
department
of
health
Cholestech
Technical
for
an
application
(form
Cholestech
Run
he Optics
the Optics
CheckCheck
must must
haveofhave
a health
CLIAa Certificate
CLIA
Waiver
of
before
before
starting
testing.
testing.
ToWhen
obtain
Tostored
obtain
a Certificate
a Certificate
of Waiver,
Waiver,
call your
call state
yourthe
state
established
established
ranges
ranges
beforebefore
patient
patient
samples
refrigerated
atof36–46˚F
(2–8˚C),
cassettes are stable
until
the
expiration
Technical
Service
can give
you samples
the can
phonecan
number of your state department
andCertificate
assistofyou
in Waiver
filling
out
the starting
How
should
should
I stor
Is
patient
samples
samples
are are
eont
te
into
the
intoAnalyzer
the
the
Analyzer
Analyzer
Press
Press
Press
RUN.RUN.
The
RUN.drawer
The
Thedrawer
drawer
will close.
will
willclose.
close.
WhenWhen
When
the test
the
theis
test
testisis
PressPress
Press
the DATA
the
the
button
DATA
button
button
the
ononCholestech
Analyzer
the
theAnalyzer
Analyzer
once
once
oronce
ororService
The
results
The
The
results
will
print
will
will
print
when
printcan
when
when
thebe(form
test
the
thetest
istest
finished.
isisroom
finished.
finished.
department
department
of DATA
health
of health
oronCholestech
or
Technical
Technical
Service
(1.800(1.800
733.0404)
733.0404)
forresults
an
forapplication
an
application
(form
HCFA-116).
HCFA-116).
Cholestech
Cholestech for How
be tested.
be tested.
pouch
and
box.
Cassettes
stored
at
temperature
30 days. Do not use a c
application.
has
LDX
been
has
been
moved
moved
When
When
stored
stored
refrigerated
ar
ward
bar
toward
toward
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you
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date. Do not return cassettes to the refrigerator once they have been stored at room temperature.
duestions
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about
about
thethe
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useuse
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the
Cholestech
Cholestech
Cholestech
LDXLDX
LDX
holestech LDX
 11578 Sorrento Valley Road, Suite 25/26, San Diego, CA 92121  tel (858) 481-5031 
toll free (888) 882-7739  e-mail: [email protected]
fax
(801) 720-7568