Product no.
For
in vitro
diagnostic use
ELITech Clinical Systems SAS
Zone Industrielle
61500 SEES
France
For Technical questions, Please call or contact
(855) 354-8324 - www.elitechgroup.com
27 Wellington Road
Lincoln, Rhode Island 02865 - U.S.A.
ELITech Clinical Systems SAS
Zone Industrielle
61500 SEES
France
For Technical questions, Please call or contact
(855) 354-8324 - www.elitechgroup.com
27 Wellington Road
Lincoln, Rhode Island 02865 - U.S.A.
APPLICATION PARAMETERS
CAUTION : Federal Law restricts this device to sale by or on the order of
a licensed healthcare practitioner (Rx ONLY)
INTENDED USE
Envoy® 500 HDL Cholesterol Reagent is for the quantitative determina-
tion of high density lipoprotein (HDL) cholesterol in serum and plasma
on Envoy 500 Series Analyzers.
SUMMARY
The principle role of high density lipoproteins (HDL) in lipid metabolism
is the uptake and transport of cholesterol from the peripheral tissues
to the liver through a process known as reverse cholesterol transport,
which is a proposed cardio-protective mechanism.
1
Low HDL-cholesterol
levels are associated with an increased risk of coronary heart disease
and coronary artery disease. Consequently the determination of serum
HDL-cholesterol is a useful tool for identifying high risk patients.
HDL-cholesterol results may also be indicative of various lipid disorders
such as diabetes mellitus and other liver and renal diseases.
2
HDL cholesterol is measured using a two step process.
Step 1
:
Accel CO + POD + DSBmT
HDL, LDL, VLDL, Chylomicrons
Non Reactive LDL, VLDL, Chylomicrons
Step 2:
HDL Specific Detergent
HDL-Cholesterol
HDL
Disrupted
CO + CE
HDL-Chole O
2
Cholest-4-ene-3-one + H
2
O
2
POD
2 H
2
O
2
+ 4-Aminoanti DSBmT
Colored End Product
Non HDL-esterified and free cholesterol are consumed by cholesterol
oxidase, peroxidase and DSBmT in step 1 yielding colorless products.
HDL cholesterol is unaffected. Reagent 2 contains cholesterol esterase,
a chromogenic coupler, and a detergent capable of selectively solubiliz-
ing the HDL cholesterol. In step 2, this reagent is added and the HDL
cholesterol reacts to produce a chromogen that absorbs at 578 nm.
The change in absorbance is proportional to the concentration of HDL
cholesterol in the sample.
This reaction scheme may be referred to as the Accelerator Selective
Detergent methodology.
REAGENTS
COMPOSITION
HDL Cholesterol Reagent 1 contains < 1,000 U/L cholesterol oxidase (E.
coli), < 1,300 ppg U/L peroxidase (horseradish), < 1 mmol/L disodium N, N-bis
(4-sulfobutyl)-
m
-toluidine, < 1 mmol/L accelerator, < 0.06% preser-
vative, < 3,000 U/L ascorbate oxidase (Curcubita), buffer, and other
ingredients. HDL Cholesterol Reagent 2 contains < 1,500 U/L choles-
terol esterase (Pseudomonas sp.), < 1 mmol/L 4-aminoantipyrine,
< 2% detergent, < 0.06% preservative, buffer, and other ingredients.
WARNINGS AND PRECAUTIONS
- This reagent is for professional
in vitro
diagnostic use only.
- Take normal precautions and adhere to good laboratory practice.
- Use clean or single use laboratory equipment only to avoid contam-
inations.
- Dispose of contents in accordance with all local, state and federal
regulations.
- For more information, Safety Data Sheet (SDS) is available on
request for professional user.
PREPARATION
Both HDL Cholesterol Reagent 1 and HDL Cholesterol Reagent 2 are
ready for use as packaged.
STORAGE AND STABILITY
Store these reagents at 2 to 8 °C. Do not freeze. Unopened reagents are
stable to the expiration dates on the bottle labels.
Open reagents are stable for 28 days onboard the Envoy 500 Chemistry
System.
SPECIMENS
SERUM AND PLASMA COLLECTION AND STORAGE
- Fasting serum is the preferred specimen. Fasting heparinized plasma is
also acceptable. Do not analyze whole blood. Collect specimens by veni-
puncture according to accepted clinical protocol. Patients should maintain
their usual diet for at least two weeks before blood collection. Blood should
be drawn after a 12 hour fast and after the subject has been sitting quietly
for at least 5 minutes. Separate the serum or plasma sample from the cells
within three hours of collection.
3
- Venipuncture should be performed prior to the administration of drugs. Of
particular note, venipuncture performed during an acetaminophen overdose
situation, when N-acetyl-p-benzoquinone imine (NAPQI) an atypical meta-
bolic breakdown product of acetaminophen, may be present, may lead to
erroneously low HDL Cholesterol results. Venipuncture performed during or
immediately after administration of N-acetylcysteine (NAC), a drug used to
treat acetaminophen overdose, or Metamizole may lead to erroneously low
HDL cholesterol results.
- For best results, HDL should be analyzed on the day of collection. HDL
Cholesterol in serum and plasma is stable for up to two days at 2 to 8 °C,
one month at -20 °C, or 2 years at -70 °C. Once thawed, the specimen may
not be refrozen.
3
COMPATIBLE ADDITIVES
Acceptable chemical preservatives are lithium and sodium heparin. Do not
use anticoagulants containing citrate or any other chemical additives.
PROCEDURE
MATERIALS PROVIDED
The Envoy 500 HDL Cholesterol Reagent Kit includes the following compo-
nents:
4 x 30.4 mL boats of Envoy 500 HDL Cholesterol Reagent 1
4 x 11.4 mL bottles of Envoy 500 HDL Cholesterol Reagent 2
MATERIALS REQUIRED BUT NOT PROVIDED
Envoy 500 HDL Calibrator (product no. 55119)
Envoy 500 Serum Controls (product no. 55131)
Normal saline (0.85% saline)
ASSAY PROCEDURE
Program the instrument using the application parameters and programming
instructions provided at the end of this Instructions For Use.
REAGENT INSTALLATION AND USE
The Envoy 500 HDL Cholesterol Reagent is ready to use as packaged.
Snap the small reagent bottle onto the reagent boat if it has become
dislodged during shipping. Mix the reagents by gently inverting the
assembled boat several times.
Record the installation date on the label and insert the assembled boat
into the designated position on the reagent tray.
Let the reagent equilibrate on the instrument for at least 30 minutes
before use.
.../...
ENVOY
®
500 HDL CHOLESTEROL REAGENT KIT
Product no. 55301
For
in vitro
diagnostic use
(10/2015)
FTEVY-HDLL-v5
PROGRAMMING INSTRUCTIONS
Detailed instructions for programming reagent parameters are provided in
the Envoy 500 Operator manual and Envoy 500 Settings Table.
If the Envoy 500 Chemistry System is not pre-programmed, a HDL choles-
terol code must first be added before the parameters can be entered. On
the menu bar, select «Test
Test Directory.» A new window will open up
listing all the codes for the tests that are installed on the instrument. Click on
the «New Code» button, type «HDL» into the Code field and select «Save.»
To program the application parameters, check the box next to the code for
the HDL test, and select the «Parameters» button located at the bottom of
the window. To program standard information, click the «Standards» button
located at the bottom of the window.
PRIMARY PARAMETERS
Code HDL
Bar-Code Active
Code for Bar-Code
310
Test Methodology
Selective
Method Sample
Blank
(A)
Kind of Process
Linear
1st Filter
578
2nd Filter
700
Reaction direction
Increasing
REAGENTS
Number of reagents
2
Reagent 1 Volume
μ
L 300
Concentrated
Inactive
Reagent 2 Volume
μ
L 100
Concentrated
Inactive
SAMPLE
Serum Urine
Name
HDL
Cholesterol
Sample
μ
L 4
N/A
Pre-Dilution
1:
1
N/A
Post-Dilution
1:
1
N/A
TIMES
Sample
Starter
Inactive
Delay
Time
0
Reading
Time
60
Reagent 1 Incubation Time
300
Reagent 2 Incubation Time
240
CHECK PARAMETERS
Reagent Limit (mABS)
200
Curve Acceptance (%)
100
RE-RUN SERUM
Test Limit (Conc)
150
Low Test Limit (Conc)
1.1
Initial ABS (mABS)
N/A
Final ABS (mABS)
N/A
Max ABS Delta (mABS)
N/A
Prozone
Check
Inactive
Normal
Range Min
Max
Man
[User
defined]
Woman [User
defined]
Child [User
defined]
Re-run
hyperactive
Inactive
Re-run
pathological
Inactive
RE-RUN URINE
Test Limit (Conc)
N/A
Low Test Limit (Conc)
N/A
Initial ABS (mABS)
N/A
Final ABS (mABS)
N/A
Max ABS Delta (mABS)
N/A
Prozone
Check
Inactive
Normal
Range Min
Max
Man
N/A
Woman
N/A
Child
N/A
Re-run
hyperactive
Inactive
Re-run
pathological
Inactive
SECONDARY PARAMETERS
1
st
Unit Serum
mg/dL
2
nd
Unit Serum
Inactive
1
st
Unit Urine
N/A
2
nd
Unit Urine
Inactive
Dynamic Blank
Active
Needle washes
[From Settings Table]
Cuvette washes
[From Settings Table]
Special wash
[From Settings Table]
Instrumental Factor 1.000
Shift 0.000
Reagent Blank
Every Day
Decimals 0
STANDARD PARAMETERS
Factor
[Determined by calibration]
Minimum 270
Maximum 900
No. of Samples
1
Max Var. (%)
10
Timed re-run
Inactive
N. replicates
3
Reagents ABS
[Determined by Envoy]
Pos.
[From Settings Table]
Conc.
[From calibrator label]
ABS [Determined
by
Envoy]
% last calibration
100
(10/2015)
FTEVY-HDLL-v5
ENVOY
®
500 HDL CHOLESTEROL REAGENT KIT