2797
AU/DxC AU HDL
Instructions For Use HDL-CHOLESTEROL
© 2025 Beckman Coulter, Inc. All rights reserved.
OSR6187 4 x 27 mL R1, 4 x 9 mL R2
OSR6287 4 x 51.3 mL R1, 4 x 17.1 mL R2
OSR6687 4 x 138 mL R1, 4 x 55 mL R2
For in vitro diagnostic use only.
PRINCIPLE
INTENDED PURPOSE
HDL-Cholesterol reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for
the quantitative measurement of HDL-Cholesterol in human serum and plasma using the automated Beckman Coulter
AU/DxC AU analyzers.
Measurement of HDL-cholesterol is intended to be used as an aid in cardiac risk assessment.
SUMMARY AND EXPLANATION
Reference1
Approximately 25% of total serum cholesterol is transported in the HDL fraction. Numerous clinical and epidemiological
studies have demonstrated a strong inverse association between HDL-cholesterol and the incidence of coronary heart
disease. It has been proposed that the uptake and transport of cholesterol from peripheral tissue to the liver acts as
a protective factor against the development of atherosclerotic plaques. Determination of HDL-cholesterol is therefore
essential for the interpretation of individual cholesterol determinations. Low HDL-cholesterol is a risk factor independent
of total cholesterol concentration and is highly predictive of the risk of coronary heart disease. Measurement of
HDL-cholesterol is used in the early recognition of atherosclerosis risk, and may also be used in the monitoring of
individuals during treatment with lipid lowering drugs.
METHODOLOGY
Anti human-β-lipoprotein antibody in R1 binds to lipoproteins other than HDL (LDL, VLDL and chylomicrons). The
antigen-antibody complexes formed block enzyme reactions when R2 is added. HDL-cholesterol is quantified by the
presence of an enzyme chromogen system.
CHEMICAL REACTION SCHEME
Anti human - β -
lipoprotein antibody
LDL,VLDL and chylomicrons Antigen–Antibody complexes
CHE and CHO
HDL-cholesterol + H2O + O2 Cholest-4-en-3-one + Fatty acids + H2O2
POD
H2O2 + 4 – AA + F–DAOS Blue dye+ + F- + 2H2O
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SPECIMEN
TYPE OF SPECIMEN
Serum and Na/Li-heparinized plasma (fasting and non-fasting).
SPECIMEN STORAGE AND STABILITY
Stable for 7 days when stored at 4…8°C and 2 days when stored at 20…25°C.2
Specimen storage and stability information provides guidance to the laboratory. Based on specific needs, each laboratory
may establish alternative storage and stability information according to good laboratory practice or from alternative
reference documentation.
REAGENTS
WARNING AND PRECAUTIONS
Exercise the normal precautions required for handling all laboratory reagents.
Dispose of all waste material in accordance with local guidelines.
This product contains material of animal origin. The product should be considered as potentially capable of transmitting
infectious diseases.
ACTIVE INGREDIENTS
Final concentration of active ingredients:
Anti human-β-lipoprotein antibody Variable
Cholesterol esterase (CHE) 0.8 IU/mL
Cholesterol oxidase (CHO) 4.4 IU/mL
Peroxidase (POD) 1.7 IU/mL
Ascorbate Oxidase 2.0 IU/mL
Good's buffer (ph 7.0) 30 mmol/L
N-Ethyl – N - (2-hydroxy-3-sulfopropyl) - 3.5– dimethoxy – 4 fluoroaniline (F–DAOS) 0.20 mmol/L
4-Aminoantipyrine 0.67 mmol/L
Preservative
Detergent
The concentrations of the components of the reagents shown on the kit label are the actual concentrations in the
individual R1/R2 vials. The reagent composition which is shown in the Instructions For Use is the final concentration of
these components in the reaction cuvette after addition of R1, Sample, and R2.
GHS HAZARD CLASSIFICATION
HDL Metabolite English Instructions For Use BLOSR6X87EU 03
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HDL Cholesterol R1 WARNING
H317 May cause an allergic skin reaction.
H411 Toxic to aquatic life with long lasting effects.
P273 Avoid release to the environment.
P280 Wear protective gloves, protective clothing and eye/face
protection.
P333+P313 If skin irritation or rash occurs: Get medical
advice/attention.
P362+P364 Take off contaminated clothing and wash it before use.
P391 Collect spillage.
reaction mass of: 5-chloro-2-methyl-4-isothiazolin -3-one
[EC# 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC#
220-239-6](3:1) < 0.05%
Safety Data Sheet is available at [Link]/techdocs
REAGENT PREPARATION
The reagents are ready for use and can be placed directly on board the instrument.
REAGENT STORAGE AND STABILITY
Closed vial shelf life per stability study: 20 months.
The reagents are stable, protected from light, unopened, up to the stated expiry date when stored at 2…8°C.
Opened bottles of reagent are stable for 30 days when stored in the refrigerated compartment of the analyzer.
The colour of R2 may turn to light green when stored on board the analyser. This does not affect the performance of the
reagent.
INDICATIONS OF DETERIORATION
Visible signs of microbial growth, gross turbidity, precipitate, or change in color may indicate degradation and warrant
discontinuance of use.
CALIBRATION
CALIBRATOR REQUIRED
HDL-Cholesterol Calibrator ODC0011.
Recalibrate the assay every 30 days and perform reagent blank every 7 days, or when the following occur:
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OCTOBER 2025 Page 3 of 8
Change in reagent bottle or significant shift in control values;
Major preventative maintenance was performed on the analyzer or a critical part was replaced.
The reagent blank and calibration curves should be visually reviewed for acceptability. Instructions on how to perform
the review are provided in the relevant AU/DxC AU analyzer IFU and Reference Manual. Quality control procedures
should be undertaken immediately following calibration in accordance with good laboratory practice.
TRACEABILITY
The calibrator is traceable to the US CDC (Centre for Disease Control) HDL-cholesterol reference method.
QUALITY CONTROL
HDL/LDL-Cholesterol Control Serum ODC0005 or other control materials with values determined by this method may
be used.
Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be
tested each day patient samples are tested and each time calibration/blanking is performed.
The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that
each laboratory generates analyte specific control target values and intervals based on multiple runs according to their
requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product
literature.
If any trends or sudden shifts in values are detected, review all operating parameters.
Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified
limits.
TESTING PROCEDURE(S)
Refer to the appropriate Beckman Coulter AU/DxC AU analyzer Instructions For Use (IFU) for analyzer-specific assay
instructions for the sample type as listed in the Intended Purpose statement.
CALCULATIONS
The Beckman Coulter analysers automatically compute the HDL-cholesterol concentration of each sample.
REPORTING RESULTS
REFERENCE INTERVALS
National Cholesterol Education Program (NCEP) guidelines3
< 1.03 mmol/L (< 40 mg/dL) Low HDL-cholesterol (major risk factor for coronary heart disease)
≥ 1.55 mmol/L (≥ 60 mg/dL) High HDL-cholesterol (“negative” risk factor for coronary heart disease)
Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify
the transferability of the expected values to its own population, and if necessary determine its own reference interval
according to good laboratory practice. For diagnostic purposes, results should always be assessed in conjunction with
the patient's medical history, clinical examinations and other findings.
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PROCEDURAL NOTES
LIMITATIONS
When triglyceride in a sample exceeds 11.3 mmol/L (1,000 mg/dL), dilute the sample with a saline solution, repeat assay
and multiply result by dilution factor.
INTERFERENCES
Results of studies conducted to evaluate the susceptibility of the method to interference were as follows:
Ascorbate : Interference less than 3% up to 20 mg/dL ascorbate
Bilirubin: Interference less than 3% up to 40 mg/dL or 684 µmol/L bilirubin
Haemolysis: Interference less than 3% up to 5 g/L haemoglobin
Lipemia: Interference less than 10% up to 900 mg/dL *Intralipid
*No significant interference was observed from samples containing native triglycerides up to 11.3 mmol/L (1,000 mg/dL),
however there is poor correlation between lipemia and triglyceride concentration – see limitations section.
Venipuncture immediately after or during the administration of Metamizole (Dipyrone) may lead to falsely low results for
HDL Cholesterol. Venipuncture should be performed prior to the administration of Metamizole.
N-acetyl-p-benzoquinone imine (metabolite of Paracetamol) will generate erroneously low results in samples for patients
that have taken toxic doses of paracetamol.
Further information on interfering substances is available.4
PERFORMANCE CHARACTERISTICS
PERFORMANCE CHARACTERISTICS
Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your
laboratory may differ from these values.
ANALYTICAL MEASURING RANGE/LINEARITY
ANALYTICAL MEASURING RANGE 0.05 - 4.65 mmol/L 2 - 180 mg/dL
SENSITIVITY
The Limit of Detection (LoD) and the Limit of Quantitation (LoQ) were determined in accordance with the CLSI EP17-A2
guideline.5
Correctly operating AU/DxC AU systems should exhibit the following LoD/LoQ:
LoD/LoQ ≤ 0.05 mmol/L (≤ 2 mg/dL)
LoD is defined as the lowest concentration that can be detected with a probability of 95%.
LoQ is the lowest level of measurand which can be quantitatively determined with a within-laboratory CV of ≤ 20%,
established as per EP17-A2.
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METHODS COMPARISON
Patient serum samples were evaluated in method comparison studies.
Results of Deming regression analysis were as follows:
DxC 700 AU versus AU680
y = 0.998x + 0.026 r = 0.999 n = 112 Sample range = 0.20 - 4.53 mmol/L
PRECISION
Correctly operating AU/DxC AU systems should exhibit the following precision values:
TYPE OF IMPRECISION % CV
Repeatability (Within-run) ≤ 3
Within Laboratory (Total) ≤ 4
Estimates of precision, based on CLSI recommendations6 are consistent with typical performance.
The following data was obtained on a representative analyzer using 3 serum pools analyzed over 20 days:
AU680
n = 80 Repeatability (Within-run) Within Laboratory (Total)
Mean mmol/L SD CV% SD CV%
0.58 0.01 0.9 0.01 2.4
1.01 0.01 0.8 0.02 2.1
1.89 0.02 1.0 0.03 1.8
ADDITIONAL INFORMATION
DxC 700 AU analyzers require that each reagent application has a standard format of abbreviated Test Name. This Test
Name is required to allow automated loading of the calibrator information for each application. Refer to the table below
for the Test Name assigned to each application for this assay.
Test Name Description
HDL1N HDL-Cholesterol (Serum)
Setting Sheet Footnotes
# User defined
† HDL Cholesterol Calibrator Cat. No.: ODC0011
* Values set for working in SI units (mmol/L). To work in mg/dL multiply by 38.7.
‡ Perform reagent blank every 7 days
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Notice to User
Any serious incident that has occurred in relation to this device should be reported to Beckman Coulter and the competent
authority of the Member State in which the user and/or patient is established.
OSR6687 for use on the AU5800 systems only.
Refer to the Beckman Coulter Chemistry Systems Reagent Guide (BLGUIDE) for specific chemistry information for the
AU/DxC AU clinical chemistry systems and guidance on symbols used on all AU/DxC AU product labelling.
REVISION HISTORY
Updated Performance Characteristics section
Updated References section
Preceding version revision history
Updated method comparison section
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REFERENCES
1. Riesen WF. Lipid metabolism. In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical
laboratory results. Frankfurt/Main: TH-Books Verlagsgesellschaft, 1998:171-173.
2. Ehret W, Heil W, Schmitt Y, Töpfer G, Wisser H, Zawta B, et al. Use of anticoagulants in diagnostic laboratory
investigations and stability of blood, plasma and serum samples. WHO/DIL/LAB/99.1 Rev.2:26pp.
3. National Cholesterol Education Program Expert Panel. Executive summary of the third report of the National
Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood
Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285: 2486-2497.
4. AACC Effects on Clinical Laboratory Tests: Drugs, Disease, Herbs and Natural Products
[Link]
5. Clinical and Laboratory Standards Institute: Evaluation of Detection Capability for Clinical Laboratory Measurement
Procedures; Approved Guideline - Second edition. CLSI document EP17-A2, Wayne PA 2012.
6. Clinical and Laboratory Standards Institute. Evaluation of Precision of Quantitative Measurement Procedures;
Approved Guideline - Third Edition. CLSI document EP05-A3, Wayne PA 2014.
Beckman Coulter Ireland Inc., Lismeehan, O’Callaghan’s Mills, Co. Clare, Ireland +(353) (0) 65 683 1100
[Link]
HDL Metabolite English Instructions For Use BLOSR6X87EU 03
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