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CardioPhase™ High Sensitivity C‑Reactive

Protein (hsCRP)
Current Revision and Datea Rev. F, 2020-02

Product Name ADVIA® Chemistry CardioPhase™ High Sensitivity C‑Reactive REF 06837459
Protein (hsCRP) Reagents

Systems ADVIA 1800 Chemistry System


ADVIA 2400 Chemistry System

Materials Required but Not ADVIA Chemistry CardioPhase High Sensitivity C‑Reactive REF 05006455
Provided Protein Calibrators
Reagent container adapters
Commercially available controls

Specimen Types Human serum, plasma (lithium heparin, potassium EDTA)

Assay Principle Latex-enhanced immunoturbidimetric

Assay Range Serum: 0.16–10.0 mg/L


Plasma: 0.16–10.0 mg/L

Reagent Storage 2–8°C

Reagent On‑System Stability 60 days

Reagent Code 74701


a In Rev. E or later, a vertical bar in the margin indicates a technical update to the previous version.

Intended Use
For in vitro diagnostic use in the quantitative determination of the concentration of C‑reactive
protein (CRP) in human serum and plasma (lithium heparin or potassium EDTA) on
ADVIA® Chemistry systems. In acute-phase response, increased levels of a number of plasma
proteins, including CRP, are observed.
Measurement of CRP is useful for the detection and evaluation of infection, tissue injury,
inflammatory disorders, and associated diseases. High-sensitivity CRP (hsCRP) measurements
may be used as an independent risk marker for the identification of individuals at risk for
future cardiovascular disease. Measurement of hsCRP, when used in conjunction with
traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an
independent marker of prognosis for recurrent events in patients with stable coronary disease
or acute coronary syndromes.1–9

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hsCRP ADVIA 1800/2400 Chemistry Systems

Summary and Explanation


In most normal individuals, CRP is an acute-phase protein that is present in serum and plasma
in very low concentrations. CRP serum concentrations become elevated in response to many
pathological conditions, including infection, tissue injury, inflammatory disorders, and
associated diseases. Increases in CRP values are non-specific for many disease processes and
should not be interpreted without a complete clinical evaluation.
Studies have shown that measurement of CRP by high sensitivity assays is a strong
independent predicator of risk for future cardiovascular and peripheral vascular disease.5,6
High sensitivity CRP measurements have also been shown to add to the predictive value of
other markers used to assess the risk of cardiovascular and peripheral vascular disease.6,8
Elevated CRP values determined by high sensitivity CRP assays may be indicative of the
prognosis of individuals with acute coronary syndromes, and may be useful in the
management of such individuals.5

Principles of the Procedure


The ADVIA Chemistry CardioPhase High Sensitivity C‑Reactive Protein (hsCRP) assay is a
suspension of uniform polystyrene latex particles coated with anti-CRP antibody. When serum
or plasma containing CRP is mixed with the latex reagent, agglutination takes place resulting
in an increase in turbidity. This turbidity is measured at 571 nm. The CRP concentration in
serum or plasma is determined from a calibration curve that is generated with the calibrators.

Reagents
Reagent Description Storage Reagent Stability

REF 06837459 ADVIA Chemistry CardioPhase High Sensitivity C‑Reactive Protein (hsCRP)
Reagents

CardioPhase High Sensi- 13.0 mL in 20-mL containers 2–8°C Unopened: Stable until the
tivity C‑Reactive Protein Glycine (170 mmol/L) expiration date on product.
Reagent 1 NaCl (100 mmol/L) On‑system: 60 days
EDTA Disodium Salt Dihydrate
(50 mmol/L)
NaN3 (0.09%, weight/volume)

CardioPhase High Sensi- 13.0 mL in 20-mL containers 2–8°C Unopened: Stable until the
tivity C‑Reactive Protein CRP Antibody (rabbit)-synthetic latex expiration date on product.
Reagent 2 (lot-specific) On‑system: 60 days
NaN3 (0.09%, weight/volume)

Warnings and Precautions


Safety data sheets (MSDS/SDS) available on siemens.com/healthcare.

Caution
This device contains material of animal origin and should be handled as a potential carrier and
transmitter of disease.

Contains sodium azide as a preservative. Sodium azide can react with copper or lead plumbing
to form explosive metal azides. On disposal, flush reagents with a large volume of water to
prevent the buildup of azides. Disposal into drain systems must be in compliance with
prevailing regulatory requirements.
Dispose of hazardous or biologically contaminated materials according to the practices of your
institution. Discard all materials in a safe and acceptable manner, and in compliance with
prevailing regulatory requirements.

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ADVIA 1800/2400 Chemistry Systems hsCRP

Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed
healthcare professional.
For in vitro diagnostic use.

Preparing Reagents
All reagents are liquid and ready to use.
Before use, gently invert the capped reagent to disrupt bubbles and ensure homogeneity. If
bubbles still exist or foam is present, use a clean transfer pipette to aspirate them from the
reagent container prior to use.

Storing and Stability


Unopened reagents are stable until the expiration date printed on the product label when
stored at 2–8°C. Do not freeze reagents.

Specimen Collection and Handling


Siemens Healthcare Diagnostics validated serum and plasma (lithium heparin and potassium
EDTA) for the ADVIA Chemistry hsCRP assay.
The purpose of handling and storage information is to provide guidance to users. It is the
responsibility of the individual laboratory to use all available references and/or its own studies
when establishing alternate stability criteria to meet specific needs.

Collecting the Specimen


Follow these guidelines for specimens used for this assay:
• Serum and plasma can be collected using recommended procedures for collection of
diagnostic blood specimens by venipuncture.10 Follow the instructions provided with your
specimen collection device for use and processing.11
• Complete clot formation should take place before centrifugation.
• Serum or plasma should be physically separated from cells as soon as possible with a
maximum limit of 2 hours from the time of collection.12
• All human source samples should be considered potentially infectious and handled with
caution.
• Specimens should be free of particulate matter.
• Specimens should be as fresh as possible.

Storing the Specimen


Follow these guidelines for specimens used for this assay:
• CRP specimens are stable for 3 days at 4–8°C or 6 months at -20°C or lower.13
• Avoid repetitive freezing and thawing of specimens.
• Centrifuge samples containing precipitates before performing the assay.

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hsCRP ADVIA 1800/2400 Chemistry Systems

Procedure
Materials Provided
The following materials are provided:

Item Contents Number of Tests

REF 06837459 Reagent 1: 2 × 20‑mL containers 2 × 220


Reagent 2: 2 × 20‑mL containers

Materials Required but Not Provided


The following materials are required to perform this assay, but are not provided:

Item Description

REF 05006455 ADVIA Chemistry CardioPhase High Sensitivity C‑Reactive Protein Calibrators

REF 02404085 20-mL reagent container adapter for 40-mL slot (ADVIA 1800)

REF 00771668 20‑mL reagent container adapter for 70‑mL slot (ADVIA 2400)

Commercially available control materials

Assay Procedure
Sampling, reagent delivery, mixing, and processing are automatically performed by the
ADVIA Chemistry system.
For detailed information on performing the procedure, refer to the system operating
instructions.

Preparing the System


For detailed information on preparing the system, refer to the system operating instructions.

Preparing the Samples


Before placing samples on the system, ensure that samples have the following characteristics:
• Samples are free of fibrin or other particulate matter.
• Samples are free of bubbles.

On-System Stability
The ADVIA Chemistry hsCRP reagent is stable on the system for 60 days.
Do not use reagents beyond the expiration date.

Performing Calibration
To calibrate the ADVIA Chemistry hsCRP assay, use the ADVIA Chemistry CardioPhase High
Sensitivity C‑Reactive Protein Calibrators, REF 05006455.
Enter the lot-specific calibrator values that are provided with each lot of calibrator. Perform
the calibration as described in the calibrator instructions for use.

Calibration Frequency
Calibrate the assay every 28 days.

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Calibrate the assay after the following events:


• When the reagent lot number changes
• When a reagent pack is replaced by a new reagent pack with the same lot number, and
the previous reagent pack was recalibrated during use
• When a reagent pack is replaced by a new reagent pack with the same lot number, and an
additional reagent blank was run on the previous reagent pack during use
• After replacing critical optical or hydraulic components
• When indicated by quality control procedures
Individual laboratory quality control programs and procedures may require more frequent
calibration.

Reagent Blank (RBL) Frequency


The ADVIA Chemistry system measures the RBL during assay calibration.
Note Use ADVIA Chemistry CardioPhase High Sensitivity C‑Reactive Protein Calibrator - Level 1
as the sample for the RBL in this assay.

Performing Quality Control


Follow government regulations or accreditation requirements for quality control frequency.
At least once each day of use, analyze 2 levels (low and high) of a commercially available
quality control (QC) material with known C‑reactive protein concentrations.
A satisfactory level of performance is achieved when the analyte values obtained are within
the expected control range for the system or within your range, as determined by an
appropriate internal laboratory quality control scheme.
The actual frequency of control in a laboratory is based on many factors, such as workflow,
system experience, and government regulation. Each laboratory should evaluate the controls
based on the frequency established by their laboratory guidelines.
Also, assay controls under the following conditions:
• Whenever you use a new reagent lot
• Following any system maintenance, cleaning, or troubleshooting procedure
• After performing a new calibration or an additional reagent blank
Follow your laboratory internal QC procedures if the results obtained are outside acceptable
limits.

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Taking Corrective Action


If the quality control results do not fall within the expected control range or within the
laboratory’s established values, do not report results. Take the following actions:
1. Determine and correct the cause of the unacceptable control results:
a. Verify that the assay was performed according to the instructions for use.
b. Verify that the materials are not expired.
c. Verify that required maintenance was performed.
d. Rerun the assay with fresh quality control samples, and confirm that quality control
results are within acceptable limits before running patient samples.
e. If the quality control results are not within acceptable limits, recalibrate the assay, and
repeat the prior step.
f. If necessary, contact your local technical support provider or distributor for assistance.
2. After corrective action is complete, repeat required testing of patient samples before
reporting results.
Perform corrective actions in accordance with your established laboratory protocol.

Results
Calculation of Results
The system calculates and reports results based on the absorbance measurements of the test
sample during the test, and of the calibrator(s) from calibration.
The instrument calculates the concentration of C‑reactive protein in mg/L (common units and
SI units).

Interpretation of Results
Results of this assay should always be interpreted in conjunction with the patient's medical
history, clinical presentation, and other findings.

Limitations
For diagnostic purposes, CRP results should be used in conjunction with other test results, the
overall clinical presentation to the physician, and all other appropriate information.
When being used for cardiovascular risk assessment, the following precautions must be
noted:5–9
• Increases in CRP are non-specific and should not be interpreted without a complete clinical
history.
• Siemens does not recommend screening the entire adult population.
• CRP measurements are not a substitute for traditional cardiovascular risk factors.
• Acute coronary syndrome management should not depend on CRP measurement.
• Patients with persistently unexplained CRP levels above 10 mg/L should be evaluated for
other non-cardiovascular etiologies.
• Testing for cardiovascular risk assessment should not be performed while there is an
indication of active infection, systemic inflammation, or trauma.
• Secondary prevention measures should be based on an array of risk factors (global risk
assessment) and not depend on CRP.

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• Serial testing of CRP should not be used to monitor effects of treatment.


• The average of CRP results optimally repeated over 2 weeks should be used in performing
risk assessment due to the within-subject CRP variability.
As with all immunoassays, there is a potential that heterophilic antibodies may interfere with
this method. In these rare patient samples, the presence of heterophilic antibodies could
result in an anomalous result. The performance of this method has not been evaluated with
patient samples containing heterophilic antibodies. Results of this test should always be
interpreted in conjunction with the patient's medical history, clinical presentation and other
findings.
A number of substances cause physiological changes in serum or plasma analyte
concentrations. A comprehensive discussion of possible interfering substances, their serum or
plasma concentrations, and their possible physiological involvements is beyond the scope of
this document. Consult the listed reference for specific details on known potential interfering
substances.14
As with any chemical reaction, you must be alert to the possible effect on results of unknown
interferences from medications or endogenous substances. The laboratory and physician must
evaluate all patient results in light of the total clinical status of the patient.

Expected Values
The AHA/CDC Scientific Statement5 concerning inflammation and cardiovascular markers
reports the following information:

Category Reference Range

Healthy individuals ≤ 3 mg/L5–9

Low risk for cardiovascular disease prediction < 1 mg/L

Average risk for cardiovascular disease prediction > 1 mg/L and < 3 mg/L

High risk for cardiovascular disease prediction > 3 mg/L

The AHA/CDC Scientific Statement5 concerning inflammation and cardiovascular markers,


reports:
• CRP values < 1 mg/L are low risk for cardiovascular disease prediction.
• CRP values between 1–3 mg/L are average risk for cardiovascular disease prediction.
• CRP values > 3 mg/L are high risk for cardiovascular disease prediction.
Studies performed by Siemens on 190 apparently healthy volunteers yielded a median serum
CRP concentration of 1.21 mg/L and an upper 97.5th percentile serum CRP concentration of
7.59 mg/L.15
Siemens provides this information for reference. As with all in vitro diagnostic assays, each
laboratory should determine its own reference ranges for the diagnostic evaluation of patient
results. Consider these values as a guideline only.

Performance Characteristics
Analytical Measuring Range
This assay is linear from 0.16–10 mg/L.
Results that are below the assay range are flagged L. You should report the test result as
< 0.16 mg/L.
Results that are above the assay range are flagged H.

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hsCRP ADVIA 1800/2400 Chemistry Systems

Extended Measuring Range


Siemens has validated an automatic rerun condition for this assay that extends the reportable
range to 200 mg/L. You may configure the system to trigger automatic reruns.

Prozone Effect
A prozone effect was not observed for CRP concentrations up to 2000 mg/L.

Sensitivity
The ADVIA Chemistry hsCRP assay performance at low levels was analyzed as described in CLSI
protocol EP17‑A, and the limit of blank (LoB), limit of detection (LoD), and the limit of
quantitation (LoQ) were determined.16
The LoD is the smallest amount that this assay can reliably detect to determine presence or
absence of an analyte. The LoD for the ADVIA Chemistry hsCRP assay is 0.05 mg/L.
The LoQ is 0.16 mg/L, which is the lowest CRP concentration in a sample where total
imprecision is less than 10%.

Precision
The precision of the ADVIA Chemistry hsCRP assay was analyzed as described in CLSI protocol
EP05‑A2.17 Each sample was assayed 2 times per run, 2 runs per day, for at least 10 days.
ADVIA 1650/1800

Repeatability Within‑Lab
(Within‑Run) (Total)

CVb CV
Specimen Type Mean SDa (%) SD (%)

Units (mg/L)

Serum Pool-low 0.16 0.01 5.3 0.01 6.8

Serum Pool 1 0.21 0.01 3.2 0.01 4.2

Serum Pool 2 1.04 0.01 1.1 0.01 1.2

Serum Pool 3 3.12 0.03 0.8 0.04 1.3

Serum Pool 4 10.27 0.14 1.4 0.16 1.6

Control 1 0.42 0.01 2.9 0.01 3.5

Control 2 1.83 0.01 0.7 0.02 0.9

Control 3 5.39 0.05 0.9 0.05 1.0


a SD = standard deviation
b CV = coefficient of variation

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ADVIA 2400

Repeatability Within‑Lab
(Within‑Run) (Total)

CVb CV
Specimen Type Mean SDa (%) SD (%)

Units (mg/L)

Serum Pool-low 0.16 0.01 4.7 0.01 8.2

Serum Pool 1 0.20 0.01 5.9 0.01 6.6

Serum Pool 2 1.02 0.01 1.3 0.02 2.0

Serum Pool 3 3.08 0.03 0.8 0.03 1.1

Serum Pool 4 10.10 0.10 1.0 0.11 1.0

Control 1 0.41 0.01 3.6 0.02 5.1

Control 2 1.85 0.02 1.3 0.03 1.5

Control 3 5.38 0.05 0.8 0.05 1.0


a SD = standard deviation
b CV = coefficient of variation
Actual results will vary depending on the study design, and on the sample and sample
population used. Results obtained at individual laboratories may vary from the data provided.

Accuracy / Method Comparison


The performance of the ADVIA Chemistry hsCRP assay (y) was compared with the performance
of the comparison assay on the indicated system (x). Unless specified, linear least squares
regression is used for correlation calculation.
ADVIA 1650/1800

Specimen Type Comparison Assay (x) N Regression Equation Sy.x r Sample Range

Serum Siemens BN II (serum) 167 y = 1.01x - 0.01 0.13 0.998 0.17– 9.05 mg/L

Serum Siemens BN II (serum) Passing- 167 y = 1.00x + 0.01 n/a n/a 0.17– 9.05 mg/L
Bablok

Plasmaa ADVIA 1650 (serum) 58 y = 0.98x - 0.00 0.10 0.999 0.14– 9.56 mg/L

Plasmab ADVIA 1650 (serum) 58 y = 0.97x + 0.00 0.15 0.999 0.14– 9.56 mg/L
a lithium heparin
b potassium EDTA

ADVIA 2400

Specimen Regression
Type Comparison Assay (x) N r Equation Sy.x Sample Range

Serum ADVIA 1650 340 y = 0.99x + 0.01 0.05 1.000 0.12–9.92 mg/L

Serum Siemens BN II (serum) 166 y = 1.00x + 0.01 0.11 0.998 0.17–9.00 mg/L

Serum Siemens BN II (serum) 166 y = 1.00x + 0.01 n/a n/a 0.17–9.00 mg/L
Passing-Bablok

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hsCRP ADVIA 1800/2400 Chemistry Systems

Specimen Regression
Type Comparison Assay (x) N r Equation Sy.x Sample Range

Plasmaa ADVIA 2400 (serum) 46 y = 0.96x + 0.02 0.06 1.000 0.15–9.57 mg/L

Plasmab ADVIA 2400 (serum) 46 y = 0.94x + 0.03 0.06 1.000 0.15–9.57 mg/L
a lithium heparin
b potassium EDTA
The correlation of the assay may vary depending on the study design, comparable method,
and sample population. Results obtained at individual laboratories may vary from the data
provided.

Interferences
Siemens tested the following potential interferents and found the results shown below.
ADVIA 1650/1800

C‑Reactive Protein Sample


Interferent Interferent Level Concentration Interference

Bilirubin 30 mg/dL 0.56 mg/L NSIa


(conjugated and unconjugated) (513 µmol/L)

Hemolysis 500 mg/dL 0.57 mg/L NSI


(hemoglobin) (5.0 g/L)

500 mg/dL 2.87 mg/L NSI


(5.0 g/L)

Lipemiab 1000 mg/dL 0.54 mg/L NSI


(from Intralipid) (11.30 mmol/L)

Rheumatoid Factor 1040 IU/mL 3 mg/L NSI


a NSI = No significant interference. A percentage effect ≥ 10% is considered a significant interference.
b SI units calculated as triolein

ADVIA 2400

C‑Reactive Protein Sample


Interferent Interferent Level Concentration Interference

Bilirubin 30 mg/dL 0.54 mg/L NSIa


(conjugated and unconjugated) (513 µmol/L)

Hemolysis 125 mg/dL 0.53 mg/L -10%


(hemoglobin) (1.25 g/L)

500 mg/dL 2.92 mg/L NSI


(5.0 g/L)

Lipemiab 1000 mg/dL 0.51 mg/L NSI


(from Intralipid) (11.30 mmol/L)

Rheumatoid Factor 1040 IU/mL 3 mg/L NSI


a NSI = No significant interference. A percentage effect ≥ 10% is considered a significant interference.
b SI units calculated as triolein
Note There is poor correlation between turbidity and triglyceride concentration in a lipemic
sample.18

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Actual results will vary depending on the study design, the levels of the potential interferences
tested, and the samples used. Results obtained at individual laboratories may vary from the
data provided.

Standardization
The ADVIA Chemistry hsCRP assay is traceable to the Institute for Reference Materials and
Measurements (IRMM) certified reference material CRM 470 from International Federation of
Clinical Chemistry (IFCC). Assigned values of ADVIA Chemistry CardioPhase High Sensitivity
C‑Reactive Protein Calibrators are traceable to this standardization.

Technical Assistance
For customer support, please contact your local technical support provider or distributor.
siemens.com/healthcare

References
1. Ng PC, Cheng SH, Chiu KM, et al. Diagnosis of the late onset neonatal sepsis with
cytokines, adhesion molecule, and C‑reactive protein in preterm very low birthweight
infants. Archives of Disease in Childhood--Fetal and Neonatal Edition. 1997
Nov;77(3):221–227.
2. Claus DR, Osmand AP, Gewurz H. Radioimmunoassay of human C‑reactive protein and
levels in normal sera. J Lab Clin Med. 1976 Jan;87(1):120–128.
3. Konsensuswerte der DeutschenGesellschaft fur Laboratoriums-medizin, der
DeutschenGesellschaft fur Klinische Chemie und des Verbandes der Diagnostica-Industrie
e. V. (VDGH). Clin Lab. 1995; 41:743–748.
4. Kindmark CO. The concentration of C‑reactive protein in sera from healthy individuals.
Scand J Clin Lab Invest. 1972; Vol. 29, No. 4:407–111.
5. Pearson TA, Mensah GA, Alexander RW, et al. Markers of inflammation and cardiovascular
diseases; application to clinical and public health practice: A statement for healthcare
professionals from the Centers for Disease Control and Prevention and the American Heart
Association. Circulation. 2003; 107(3):499–511.
6. Tracy RP, Lemaitre RN, Psaty BM, et al. Relationship of C‑reactive protein to risk of
cardiovascular disease in the elderly. Results from the Cardiovascular Health Study and the
Rural Health Promotion project. Arterioscler Thromb Basc Biol. 1997 Jun; 17:1121–1127.
7. Macy EM, Hayes TE, Tracy RP. Variability in the measurement of C‑reactive protein in
healthy subjects: Implications for reference intervals and epidemiological applications.
Clin Chem 1997 Jan; 43(1):52–58.
8. Ricker PM, Stampfer MJ, Rifai N. Novel risk factors for systemic atherosclerosis: a
comparison of C‑reactive protein, fibrinogen, homocysteine, lipoprotein, and standard
cholesterol screening as predicators of peripheral arterial disease. JAMA 2001 May
16;285(19):2481–2485.
9. Heeschen C, Hamm C, Bruemmer J, Simoons ML. Predictive value of C‑reactive protein and
troponin T in patients with unstable angina: A comparative analysis. J Am Coll Cardiol
2000 May;35(6):1535–1542.
10. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Collection
of Diagnostic Blood Specimens by Venipuncture; Approved Guideline—Sixth Edition. CLSI
document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.

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hsCRP ADVIA 1800/2400 Chemistry Systems

11. Clinical and Laboratory Standards Institute (formerly NCCLS). Tubes and Additives for
Venous Blood Specimen Collection: Approved Standard; Approved Guideline—Sixth
Edition. CLSI document GP39-A6. Wayne, PA: Clinical and Laboratory Standards Institute;
2010.
12. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Handling
and Processing of Blood Specimens; Approved Guideline—Fourth Edition. CLSI document
GP44-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.
13. Wu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th edition, WB Saunders Company,
St. Louis, MO; 2006;190.
14. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th ed. Washington, DC: AACC
Press; 2000.
15. 97.5th percentile value (using NCCLS Reference Interval Protocol C28A, 1995), generated
from sera of 190 apparently healthy adults in New York City Metro area; data on file and
available on request.
16. Clinical and Laboratory Standards Institute (formerly NCCLS). Protocols for Determination
of Limits of Detection and Limits of Quantitation; Approved Guideline. NCCLS Document
EP17-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2004.
17. Clinical and Laboratory Standards Institute (formerly NCCLS). Evaluation of Precision
Performance of Quantitative Measurement Methods; Approved Guideline—Second
Edition. CLSI document EP05-A2. Wayne, PA: Clinical and Laboratory Standards Institute;
2004.
18. Twomey PJ, Don-Wauchope AC, McCullough D. Unreliability of triglyceride measurement
to predict turbidity induced interference. J Clin Pathol. 2003 Nov;56(11):861–862.

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Definition of Symbols
The following symbols may appear on the product labeling:

Symbol Definition Symbol Definition

In vitro diagnostic medical device Catalog number

Legal manufacturer Authorized Representative in the


European Community

CE Mark CE Mark with identification number


of notified body
0088

Consult instructions for use Biological risk

Keep away from sunlight and heat Temperature limitation

Lower limit of temperature Upper limit of temperature

Do not freeze (> 0°C) Up

Use by Contains sufficient for (n) tests

Recycle Printed with soy ink

Rev. Revision Date format (year-month-day)

Batch code RxOnly Prescription Device (US only)

Trademarks
ADVIA and CardioPhase are trademarks of Siemens Healthcare Diagnostics.
Intralipid is a trademark of Fresenius Kabi AB.
© 2008–2020 Siemens Healthcare Diagnostics. All rights reserved.

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