Elitech ENVOY 500 HDL User Manual
ENVOY
®
500 HDL CHOLESTEROL REAGENT KIT
ENVOY
®
500 HDL CHOLESTEROL REAGENT KIT
APPLICATION PARAMETERS
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 μL 300
Concentrated Inactive
Reagent 2 Volume μL 100
Concentrated Inactive
SAMPLE Serum Urine
Name HDL
Cholesterol
Sample μL 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
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 cholesterol code must first be added before the parameters can be entered. On
the menu bar, select «Test
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.
Test Directory.» A new window will open up
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
1st Unit Serum mg/dL
nd
Unit Serum Inactive
2
st
Unit Urine N/A
1
nd
Unit Urine Inactive
2
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
Product no. 55301
Product no.
For in vitro diagnostic use
For in vitro diagnostic use
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 determination 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.
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.
1
Low HDL-cholesterol
2
HDL cholesterol is measured using a two step process.
Step 1:
HDL, LDL, VLDL, Chylomicrons
Non Reactive LDL, VLDL, Chylomicrons
Step 2:
HDL-Cholesterol HDL Disrupted
HDL-Cholesterol + O
2 H2O2 + 4-Aminoantipyrine + 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 solubilizing 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.
HDL Specific Detergent
Accelerator + CO + POD + DSBmT
CO + CE
2
Cholest-4-ene-3-one + H2O
POD
2
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% preservative, < 3,000 U/L ascorbate oxidase (Curcubita), buffer, and other
ingredients. HDL Cholesterol Reagent 2 contains < 1,500 U/L cholesterol 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 contaminations.
- 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 venipuncture 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.
- 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 metabolic 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.
COMPATIBLE ADDITIVES
Acceptable chemical preservatives are lithium and sodium heparin. Do not
use anticoagulants containing citrate or any other chemical additives.
3
3
PROCEDURE
MATERIALS PROVIDED
The Envoy 500 HDL Cholesterol Reagent Kit includes the following components:
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
T
he 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.
.../...
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.
(10/2015)
FTEVY-HDLL-v5
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.
(10/2015)
FTEVY-HDLL-v5
Refer to the operator manual for additional information on installing
reagents and programming the analyzer, and running samples, calibrators and controls.
CALIBRATION
Calibrate the instrument after loading new reagent, after maintenance
and whenever quality control results fall outside established limits. Under
typical use conditions, calibration factors for this test are valid for 7 days.
Refer to the operator manual for calibration procedures.
QUALITY CONTROL
Quality control requirements should be established in accordance with
local, state and/or federal regulations or accreditation requirements.
Assay at least two levels of serum control at least daily. Control materials
may be of human or animal origin, but should represent both clinically
normal and elevated levels of high density lipoprotein cholesterol.
Controls should also be assayed after maintaining the instrument, loading a new reagent, and calibrating the analyzer.
CALCULATIONS
All calculations are performed by the instrument.
To calculate the result in SI units (mmol/L), multiply the result in
conventional units (mg/dL) by 0.0259.
LIMITATIONS / INTERFERING SUBSTANCES
- This method has not been certified by the Cholesterol Reference
Method Laboratory Network.
- Do not report results outside of the usable range.
- The results of this assay should only be interpreted in conjunction with
other diagnostic test results, clinical findings and the patient’s medical
history.
-
Lipemia may interfere with this test.
- Effects of icterus, hemolysis, and lipemia are estimated through the assay
of pools spiked with ditaurobilirubin, red blood cell hemolysate and Intralipid
20% solution. The effect of ascorbic acid was also tested. Observed biases
are shown below. Substances that affect results by more than both
3 mg/dL and 4% are reported as interfering substances in the Specimens
section.
®
Effects of Common Substances on HDL Cholesterol Recoveries
Interferant
Concentration Changes in Recoveries
Ascorbic Acid 3.0 mg/dL -0.3 at 57 mg/dL
Ditaurobilirubin 40 mg/dL* -0.7 at 57 mg/dL
RBC hemolysate 200 mg/dL* -0.8 at 56 mg/dL
Intralipid 20% solution 240 mg/dL* -3.3 at 52 mg/dL
400 mg/dL* -5.4 at 52 mg/dL
800 mg/dL* -1.5 at 54 mg/dL
2000 mg/dL* +2.5 at 54 mg/dL
* Refers to bilirubin, hemoglobin, and/or triglyceride concentration
† Effect is not statistically significant at α = 0.05.
‡ The observed effect is less than 3 mg/dL. This substance is not reported as
an interfering substance.
- Results may be falsely low when the sample is taken while levels of NAC,
NAPQI (a metabolite of acetaminophen (paracetamol)) or Metamizole are
significant.
- Many other substances can affect high density lipoprotein cholesterol
results. For additional information, refer to Effects of Drugs on Clinical
Laboratory Tests
Laboratory Tests.
7
and Effects of Preanalytical Variables on Clinical
8
†
‡
‡
PERFORMANCE CHARACTERISTICS
USABLE RANGE
The linear range of this assay is listed below. Specimens that exceed
the upper limit of this range should be diluted with normal saline and
reanalyzed. Multiply the results of diluted specimens by the appropriate
dilution factors.
Conventional Units SI Units
5 to 150 mg/dL 0.13 to 3.89 mmol/L
EXPECTED VALUES
The NCEP (American National Cholesterol Education Program) has
established the following classification for HDL cholesterol levels
according to the risk of developing coronary heart disease
Risk Classification Conventional Units SI Units
High risk < 40 mg/dL < 1.03 mmol/L
Low risk ≥ 60 mg/dL ≥ 1.55 mmol/L
LIMIT OF DETECTION
The limit of detection (LoD) for HDL cholesterol is 0.46 mg/dL, which
was determined based on the NCCLS protocol EP17-A
of false positives (α) less than 5% and false negatives (β) less than 5%.
This LoD is based on 80 determinations, with 40 blank and 40 low level
samples, and LoB = 0.29 mg/dL.
ANALYTICAL SENSITIVITY
An absorbance change of 0.003 A on the Envoy 500 Chemistry System
corresponds to a change in HDL cholesterol concentration of approximately
1 mg/dL (0.03 mmol/L).
METHOD COMPARISON
One hundred and sixty serum and 152 plasma specimens were collected
from individual adult patients and assayed for high density lipoprotein
cholesterol using an Envoy 500 Chemistry System and another commercially available method. Results were compared by least squares and
Passing - Bablok regression and the following statistics were obtained.
n = 312 range = 5 to 158 mg/dL
Least Squares Regression
Envoy 500 = 0.7 mg/dL + 1.021 x Competitive Method
s
= 2.4 mg/dL r = 0.995
(y.x)
Passing - Bablok Regression
Serum/Plasma Comparison
4
:
5
with proportions
Envoy 500 = 0.7 mg/dL + 1.015 x Competitive Method
PRECISION
Two lipid controls were each assayed in triplicate twice per day over 8
days on an Envoy 500 Chemistry System. Estimates of within run and total
imprecision are calculated analogous to the methods described in NCCLS
publication EP3-T.
6
Precision of HDL Cholesterol Recoveries in mg/dL
Within Run Total
Sample n mean 1SD %CV 1SD %CV
Level 1 45 36.8 0.52 1.4% 0.72 2.0%
Level 2 48 71.1 0.68 1.0% 1.25 1.8%
REFERENCES
1. Badiman J J, et al. Regression of Atherosclerotic Lesions by High
Density Lipoprotein Plasma Fraction in the Cholesterol-Fed Rabbit.
Journal of Clinical Investigation 1990 85:1234-41.
2. Burtis C A, Ashwood E R, Eds. Tietz Textbook of Clinical Chemistry,
Third Edition W.B. Saunders Company: Philadelphia, PA, 1999.
3. Warnick G, et al., National Cholesterol Education Program
Recommendations for Measurement of High Density Lipoprotein
Cholesterol; Executive Summary Clin Chem, 41 10:1427 1995.
4. National Institutes of Health, National Cholesterol Education Program.
Detection Evaluation and Treatment of High Blood Cholesterol in Adults
(Adult Treatment Panel III), Final Report. NIH Publication No. 02-5215,
September 2002.
5. Protocols for the Determination of Limits of Detection and Limits of
Quantitation; Approved Guideline. NCCLS Document EP17-A. NCCLS,
Wayne PA, 2004.
6. Tentative Guidelines for Manufacturers for Establishing Performance
Claims for Clinical Chemical Methods, Replication Experiment NCCLS
Publication: Vol. 2 No. 20. Villanova, PA, 1982.
7. Young D S, Effects of Drugs on Clinical Laboratory Tests: Fifth Edition
AACC Press: Washington, DC, 2000.
8. Young D S, Effects of Preanalytical Variables on Clinical Laboratory
Tests: Second Edition AACC Press: Washington, DC, 1997.
Envoy is a registered trademark of ELITech Group.
.../...
GLOSSARY OF SYMBOLS
Contents Manufacturer Catalog No.
Batch Code
In vitro
diagnostic
device
Number
STAB DAYS
: Modification from previous version
of days
onboard
stability
R1
See instruc-
tion for use
Temperature
Limitation
Reagent 1
OPENED
R2
Use by
Date opened
/ Installation
date
Reagent 2
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.
(10/2015)
FTEVY-HDLL-v5
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.
(10/2015)
FTEVY-HDLL-v5
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