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Refer to the operator manual for additional information on installing
reagents and programming the analyzer, and running samples, calibra-
tors 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, load-
ing 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
7
and Effects of Preanalytical Variables on Clinical
Laboratory Tests
8
Laboratory Tests.
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
For Technical questions, Please call or contact
ELITech Clinical Systems SAS
Zone Industrielle
(855) 354-8324 - www.elitechgroup.com
61500 SEES
27 Wellington Road
France
Lincoln, Rhode Island 02865 - U.S.A.
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
High risk
< 40 mg/dL
Low risk
≥ 60 mg/dL
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 commer-
cially available method. Results were compared by least squares and
Passing - Bablok regression and the following statistics were obtained.
Serum/Plasma Comparison
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
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
6
publication EP3-T.
Precision of HDL Cholesterol Recoveries in mg/dL
Within Run
†
Sample
n
mean
1SD
%CV
‡
Level 1
45
36.8
0.52
1.4%
Level 2
48
71.1
0.68
1.0%
‡
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
4
:
SI Units
Batch Code
< 1.03 mmol/L
≥ 1.55 mmol/L
In vitro
diagnostic
device
Number
5
with proportions
of days
STAB DAYS
onboard
stability
: Modification from previous version
Total
1SD
%CV
0.72
2.0%
1.25
1.8%
.../...
ELITech Clinical Systems SAS
(10/2015)
Zone Industrielle
FTEVY-HDLL-v5
61500 SEES
France
Manufacturer
Catalog No.
See instruc-
Use by
tion for use
Date opened
Temperature
/ Installation
OPENED
Limitation
date
R1
Reagent 1
R2
Reagent 2
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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