COPPER

Diagnostic reagent for determination of Copper concentration.

Liquid. Monoreagent. Store at +15/+25°C. For in Vitro Diagnostic Use (IVD). Do not freeze.

Ref No Package Ref No Package Ref No Package Ref No Package

BB070 160 mL DMC20 333 mL MCU20 350 mL TBCU20 400 mL
BYC200 350 mL ER2040 60 mL M3U20 200 mL TBCU21 150 mL
BYC201 280 mL HN335 300 mL M3U21 80 mL TCU20 600 mL
CU200N 500 mL LB094 120 mL M4U20 280 mL TCU21 200 mL
CU201N 100 mL LCU20 180 mL PL2607 150 mL TCU22 100 mL
LM270 240 mL RCC200 44 mL 8AC200 350 mL
RD200 100 mL 8AC201 280 mL

Changes made in the instructions for use are marked as grey.

INTENDED USE SAMPLE

The test is applied for the quantitative determination of Serum and plasma heparinate are collected according to
Copper concentration in serum and plasma. the standard procedures.
Copper is stable for:
TEST SUMMARY AND PRINCIPLE 1, 2, 3, 4, 5 2 weeks at +20/+25ºC,
2 weeks at +2/+8°C,
3,5-Di-Br-PAESA [4-(3,5-dibromo-2-piridilazo)-N-etil-N-(3-
1 year at -20°C.
sülfopropil)anilin] combines with Copper to form a blue-
violet complex, the absorbance of which is measured at
580 nm. Unit Conversion:
µmol/L = 0.157 µg/dL
The reaction has high specificity and interference with
other cations (that should be avoided), due to their specific REFERENCE INTERVAL (NORMAL VALUES) 7
pH and environment which they constituted.
Men : 70 - 140 µg/dL
Women : 80 - 155 µg/dL
TEST PARAMETERS Pregnant women : 118 - 302 µg/dL
Method : Colorimetric, Endpoint Children 6-12 year : 80 - 190 µg/dL
Wavelength : 580 nm Infants : 20 - 70 µg/dL
Linearity : 500 µg/dL
It is recommended that each laboratory establish its own
REAGENT COMPONENTS normal range.

Acetate buffer : ≤ 120 mM pH 5

Reference interval has been verified by using CLSI EP28-
Surfactants
A3c protocol.
Preservatives
QUALITY CONTROL AND CALIBRATION
REAGENT PREPARATION
Commercially available control material with established
Reagent is ready for use. values determined by this method may be used. We
recommend:
REAGENT STABILITY AND STORAGE 6
Reagents are stable at +15/+25˚C till the expiration date Copper Control Level I-Liquid
stated on the label which is only for closed vials. Ref.No: ZA75

Once opened vials are stable for 30 days at in optimum Copper Control Level II-Liquid
conditions. On board stability is strongly related to auto Ref.No: ZA76
analyzers’ cooling specification and carry-over values.
Arcon N (Level I Control) Lyophilized
Reagent stability and storage data have been verified by Ref.No: A3910
using Clinical and Laboratory Standards Institute (CLSI)
EP25-A protocol. Arcon P (Level II Control) Lyophilized
Ref.No: A3920

Rev: V2.9 Date: 11.2022 COPPER Page 1 / 4

 Precision studies data have been verified by using CLSI
The assay requires the use of a Copper Calibrator-Liquid / EP05-A3 protocol.
Arcal Auto Calibrator. We recommend:
Method Comparison:10, 11
Copper Calibrator-Liquid Correlation with a comparative method is: r= 0.984
Ref.No: ZA77 According to Passing-Bablok Fit:
Slope: 1.046
ARCAL AUTO Intercept: -6.67
Ref.No: A39051
Ref.No: A39052 Interference:2, 3, 4, 12
No significant interference was observed for conjugated
Calibration Stability: It strongly depends on the bilirubin, lipemia up to the interferent concentration given
application characteristics of in-use auto analyser and in the table.
capacity of cooling. Calibration stability is 7 days.
COPPER
Interferant and %Observed
Each laboratory should establish its own internal Quality Target N
Concentration Recovery
Control scheme and procedures for corrective and (µg/dL)
preventive action if controls do not recover within the Bilirubin 104 3 110
acceptable tolerances. 48,33 mg/dL
Lipemia 113,5 3 105
Quality control is recommended every morning. 204 mg/dL
Calibration is not recommended if QC control values are
acceptable. Reagent should be calibrated after lot Non-hemolysis samples should be used.
changes.
The acceptable interference limit is set 10% below the
PERFORMANCE CHARACTERISTICS highest interference concentration within ± 10% recovery of
the target.
Limit of Detection (LoD): The limit of detection is 2 µg/dL.
Interferences may affect the results due to medication or
Limit of Quantitation (LoQ) [LoQ values are based on endogenous substances.
Coefficient of Variation Percentage (CV) %≤ 20]:8 3 µg/dL.
These performance characteristics have been obtained by
LoD and LoQ values have been verified by using CLSI using an analyzer. Results may vary if a different instrument
EP17A protocol. or a manual procedure is used.

High Linearity: The method is linear up to 500 µg/dL. WARNINGS AND PRECAUTIONS

For values above high linearity, dilute sample with 0.9% IVD: For in Vitro Diagnostic use only.
saline, repeat the test and multiply the result by the dilution Do not use expired reagents.
factor. Reagents with two different lot numbers should not be
interchanged.
Linearity may considerably vary depending on the For professional use.
instrument used. Follow Good Laboratory Practice (GLP) guidelines.
Contains sodium azide.
Precision Studies:9 CAUTION: Human source samples are processed with this
Repeatability (Within Run): product. All human source samples must be treated as
Mean Concentration SD* CV% n potentially infectious materials and must be handled in
46.67 µg/dL 1.08 2.33 40 accordance with OSHA standards.
103.49 µg/dL 1.31 1.26 40
Danger
Reproducibility (Day-to-Day Run): EUH032 :Releases a very toxic gas if contacts
Mean Concentration SD CV% n with acid.
47.35 µg/dL 1.31 2.77 40 H317 :May cause allergic skin reaction.
97.26 µg/dL 3.21 3.30 40
Precaution
*SD: Standard Deviation P280 :Use protective gloves / clothes / glasses
*CV: Variation Coefficient
/ mask.
P264 :Wash your hands properly after using.
±10% CV% differences can be observed between devices.

Rev: V2.9 Date: 11.2022 COPPER Page 2 / 4

 P272 :Contaminated work clothes should not 14. Tietz Textbook of Clinical Chemistry, Second Edition,
be allowed to be used outside of the Burtis-Ashwood (1994).
workplace. 15. Clin.Chem. 35/4, 552-554 (1989)
Intervention 16. Clinical and Laboratory Standards Institute (formerly
P302+P352 :Wash with plenty of water and soap if it NCCLS). Evaluation of Precision Performance of
contacts with skin. Quantitative Measurement Methods; Approved
P333+P313 :Seek medical help if it irritates your skin Guideline - Second Edition. Wayne, PA: Clinical and
or develops rash. Laboratory Standards Institute; 2004. NCCLS Document
P362+P364 :Remove contaminated clothes and EP05-A2.
wash properly before using. 17. K.Ueno, T.Imamura, K.L.Cheng - Handbook of organic
Disposal analytical reagents - CRC Press (1992).
P501 :Dispose the vials and contents 18. International Federation of Clinical Chemistry,
according to the local regulations. Committee on Reference Systems for Enzymes, Chem
Clin Lab Med 2002; 40 (7):718–724.
REFERENCES

1. Tietz, N.W., Fundamentals of Clinical Chemistry, p. 940, Archem Sağlık Sanayi ve Tic. A.Ş.
W.B. Saunders Co., Philadelphia, 1987. Mahmutbey Mah. Halkalı Cad. No:124 Kat:4
2. Tietz NW. Clinical Guide to Laboratory Test. 2nd ed. Bağcılar/İstanbul/Turkey
Philadelphia, PA: WB Saunders Company; 1995,52. Tel: + 90 212 444 08 92
Fax: +90 212 629 98 89
3. Tietz NW. Clinical Guide to Laboratory Tests. 3rd ed.
info@archem.com.tr www.archem.com.tr
Philadelphia, PA: WB Saunders Company; 1995:88-91.
4. Tietz NW, ed. Clinical Guide to Laboratory Tests. 3rd ed.
Philadelphia: WB Saunders 1995:919.
5. Tietz Fundamentals of Clinical Chemistry. 5th ed. Burtis
CA, Ashwood ER, eds. Philadelphia, PA: WB Saunders
Company; 2001:605.
6. Clinical and Laboratory Standards Institute (CLSI).
Evaluation of Stability of In Vitro Diagnostic Reagents;
Approved Guideline. CLSI Document EP25-A. Wayne,
PA: CLSI; 2009.
7. Clinical and Laboratory Standards Institute (CLSI).
Defining, Establishing and Verifying Reference Intervals
in the Clinical Laboratory; Approved Guideline – Third
Edition. CLSI Document EP28-A3c. Wayne, PA: CLSI;
2010.
8. Clinical and Laboratory Standards Institute (CLSI).
Protocols for Determination of Limits of Detection and
Limits of Quantitation; Approved Guideline.CLSI
Document EP17-A. Wayne, PA: CLSI; Vol. 24 No. 34.
9. Clinical and Laboratory Standards Institute (CLSI).
Evaluation of Precision of Quantitative Measurement
Procedures; Approved Guideline – Third Edition. CLSI
Document EP05-A3. Wayne, PA: CLSI; 2014
10. Passing-Bablok W et al. A General Regression
Procedure for Method Transformation. J Clin Chem Clin
Biochem 1988;26.783-79.
11. Clinical and Laboratory Standards Institute (CLSI).
Method Comparison and Bias Estimation Using Patient
Samples; Approved Guideline—Second Edition;
Approved Guideline.CLSI Document EP09-A2. Wayne,
PA: CLSI; Vol. 22 No. 19.
12. Clinical and Laboratory Standards Institute (CLSI).
Interference Testing in Clinical Chemistry; Approved
Guideline.CLSI Document EP07. Wayne, PA: CLSI; 3rd
Edition.CHERIAN G., SOLDIN ST. Clin. Chem.
27/5:748-752 (1981)
13. Young DS. Effects of Drugs on Clinical Laboratory Tests.
3rd ed. Washington: AACC Press (1990).

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SYMBOLS

In Vitro Diagnostic Medical

IVD Device

LOT Lot Number

R1 Reagent 1

GTIN Global Trade Item Number

REF Reference Number

GLP Good Laboratory Practices

Identifies Products to Be Used

FOR USE WITH Together

PRODUCT OF TURKEY Product of Turkey

Manufacturer

Expiration Date

Temperature Limitation

Consult Instructions for Use

Caution

Number of Tests

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