{ "ProductData": { "ID": "CPS_000064", "ProductType": "Others", "BrandName": "CERU", "ProductNameAddition": "Ceruloplasmin", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ "Serum", "Plasma" ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "CERU" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_20764663322_im_en.png", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "01-0355", "StructureNodeStatus": "Active", "NodeName": "cobas Ceruloplasmin" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "20-000-00", "StructureNodeStatus": "Active", "NodeName": "Assays Reagents and Strips" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "050-00", "StructureNodeStatus": "Active", "NodeName": "Core Lab" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "21-00-00", "StructureNodeStatus": "Active", "NodeName": "Inflammation" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "020", "StructureNodeStatus": "Active", "NodeName": "Clinical Chemistry" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "999-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Indications", "StructureSystemName": "Indications", "NodeID": "101", "StructureNodeStatus": "Active", "NodeName": "Inflammation" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "622", "StructureNodeStatus": "Active", "NodeName": "COBAS INTEGRA" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "08105553190", "MaterialDescription": "CERU, 200T, cobas c pack green", "RegisteredProductName": "CERU", "GTIN": "07613336133613", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "cobas c 303/503", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" }, { "MaterialNum": "20764663322", "MaterialDescription": "CERU, 100Tests, cobas c, Integra", "RegisteredProductName": "CERU", "GTIN": "04015630913589", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "2055953322", "PackSizePIM360": "100 tests", "PackSizeDescPIM360": "COBAS INTEGRA 400 Plus, cobas c 311/501/502", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" }, { "MaterialNum": "05950848190", "MaterialDescription": "CERU 150Tests cobas c 701", "RegisteredProductName": "CERU", "GTIN": "04015630928767", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "150 tests", "PackSizeDescPIM360": "cobas c 701/702", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "INS_2043", "BrandName": "cobas® c 311 analyzer", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "308", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 311", "StructureGroupName": "cobas c 311", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "560", "StructureGroupPath": "cobas 4000", "StructureGroupName": "cobas 4000", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_6347", "BrandName": "cobas® c 303 analytical unit", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "9493", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 303", "StructureGroupName": "cobas c 303", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_2113", "BrandName": "cobas® c 502 module", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "2324", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 502", "StructureGroupName": "cobas c 502", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_501", "BrandName": "cobas® c 701 module", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "310", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 701", "StructureGroupName": "cobas c 701", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_2177", "BrandName": "cobas® c 702 module", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "2492", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 702", "StructureGroupName": "cobas c 702", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_338", "BrandName": "cobas® c 501 module", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "309", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 501", "StructureGroupName": "cobas c 501", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "679", "StructureGroupPath": "cobas 6000", "StructureGroupName": "cobas 6000", "StructureNodeStatus": "Active" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208105553190c503", "ProductName": "CERU", "ProductLongName": "Ceruloplasmin", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000004CA390E", "DocumentOriginID": "FF00000003E6850E", "MaterialNumbers": [ "08105553190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.

Immunoturbidimetric assay

Human ceruloplasmin forms a precipitate with a specific antiserum which is determined turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.03‑1.4 g/L (0.22‑10.44 µmol/L, 3‑140 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 3.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.03 g/L (0.22 µmol/L, 3 mg/dL)

Limit of Detection

= 0.03 g/L (0.22 µmol/L, 3 mg/dL)

Limit of Quantitation

= 0.03 g/L (0.22 µmol/L, 3 mg/dL)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration ceruloplasmin samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values

g/L

Male:

0.15‑0.30 g/L

Female:

0.16‑0.45 g/L

µmol/L*

Male:

1.12‑2.24 µmol/L

Female:

1.19‑3.36 µmol/L

mg/dL*

Male:

15‑30 mg/dL

Female:

16‑45 mg/dL

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a ceruloplasmin concentration of 0.2 g/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 200. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

High-dose hook effect: No false result occurs up to a ceruloplasmin concentration of 5 g/L.

Drugs: No interference was found at therapeutic concentrations using common drug panels. Exception: Intralipid causes artificially high ceruloplasmin results.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet. For further instructions, refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105553190

Ceruloplasmin (200 tests)

System‑ID 2036 001

cobas c 303, cobas c 503

03555941190

Calibrator f.a.s. PAC (3 × 1 mL)

Code 20589

05947626160

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05947774160

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CER: ACN 20360

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R3

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

8.3 µL

10 µL

100 µL

Decreased

8.3 µL

2.5 µL

80 µL

Increased

8.3 µL

10 µL

100 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

8 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. PAC

Calibration mode

Non-linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).

LREFBaudner S, Bienvenu J, Blirup-Jensen S, et al. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins CRM470. Report EUR 15243 EN 1993;1-186.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Repeatability

Mean
g/L (mg/dL)

SD
g/L (mg/dL)

CV
%

PCCC1a)

0.169 (16.9)

0.00104 (0.104)

0.6

PCCC2b)

0.289 (28.9)

0.00126 (0.126)

0.4

Human serum 1

0.0866 (8.66)

0.000962 (0.0962)

1.1

Human serum 2

0.370 (37.0)

0.00173 (0.173)

0.5

Human serum 3

0.600 (60.0)

0.00344 (0.344)

0.6

Human serum 4

0.693 (69.3)

0.00462 (0.462)

0.7

Human serum 5

1.18 (118)

0.0106 (1.06)

0.9

Intermediate precision

Mean
g/L (mg/dL)

SD
g/L (mg/dL)

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.169 (16.9)

0.00215 (0.215)

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

0.294 (29.4)

0.00275 (0.275)

0.9

Human serum 1

0.0866 (8.66)

0.00241 (0.241)

2.8

Human serum 2

0.371 (37.1)

0.00285 (0.285)

0.8

Human serum 3

0.600 (60.0)

0.00408 (0.408)

0.7

Human serum 4

0.700 (70.0)

0.00579 (0.579)

0.8

Human serum 5

1.19 (119)

0.0135 (1.35)

1.1

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Ceruloplasmin values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 86

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.957x + 0.0164 g/L

y = 0.970x + 0.0138 g/L

τ = 0.967

r = 0.999

The sample concentrations were between 0.033 and 1.40 g/L (3.3 and 140 mg/dL).

Ceruloplasmin values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 65

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.963x + 0.0140 g/L

y = 1.004x + 0.00516 g/L

τ = 0.964

r = 0.998

The sample concentrations were between 0.0520 and 1.30 g/L (5.2 and 130 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:227-228.
,
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.
,
LREFSternlieb I. Copper and the liver. Gastroenterology 1980;78:1615-1628.

Ceruloplasmin is an acute phase protein and transport protein. The blue‑colored glycoprotein belongs to the α2‑globulin electrophoretic fraction and contains 8 copper atoms per molecule.

Incorporation of copper into the structure occurs during the synthesis of ceruloplasmin in the hepatocytes. After secretion from the liver, ceruloplasmin migrates to copper‑requiring tissue where the copper is liberated during catabolism of the ceruloplasmin molecule. In addition to transporting copper, ceruloplasmin has a catalytic function in the oxidation of iron (Fe2+ to Fe3+), polyamines, catecholamines, and polyphenols.

Decreased concentrations occur during recessive autosomal hepatolenticular degeneration (Wilson's disease). On a pathochemical level, the disease, which is accompanied by lower ceruloplasmin synthesis, occurs as a consequence of missing Cu2+ incorporation into the molecule due to defective metallothionine. This results in pathological deposits of copper in the liver (with accompanying development of cirrhosis), brain (with neurological symptoms), cornea (Kayser‑Fleischer ring), and kidneys (hematuria, proteinuria, aminoaciduria). In homozygous carriers, ceruloplasmin levels are severely depressed. Heterozygous carriers exhibit either no decrease at all or just a mild decrease. The rare Menke's syndrome involves a genetically caused copper absorption disorder with concomitant lowering of the ceruloplasmin level. Protein loss syndromes and liver cell failures are the most important causes of acquired ceruloplasmin depressions. As ceruloplasmin is a sensitive reactant to the acute phase, increases occur during acute and chronic inflammatory processes. Great increases can lead to a green‑blue coloration of the sera. Methods for assaying ceruloplasmin include immunodiffusion, nephelometry and turbidimetry.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Accelerator
Polyethylene glycol (PEG): 50 g/L; phosphate buffer; preservative

R3

Anti‑ceruloplasmin T antiserum (rabbit) specific for human ceruloplasmin: > 0.42 g/L; phosphate buffer; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 8 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

8 days at 20‑25 °C

2 weeks at 4‑8 °C

1 year at −20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108105553190c503", "ProductName": "CERU", "ProductLongName": "Ceruloplasmin", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF00000004E9A70E", "DocumentOriginID": "FF00000004C0FE0E", "MaterialNumbers": [ "08105553190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.

Immunoturbidimetric assay

Human ceruloplasmin forms a precipitate with a specific antiserum which is determined turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.03‑1.4 g/L (0.22‑10.44 µmol/L)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 3.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.03 g/L (0.22 µmol/L)

Limit of Detection

= 0.03 g/L (0.22 µmol/L)

Limit of Quantitation

= 0.03 g/L (0.22 µmol/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration ceruloplasmin samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values

g/L

Male:

0.15‑0.30 g/L

Female:

0.16‑0.45 g/L

µmol/L*

Male:

1.12‑2.24 µmol/L

Female:

1.19‑3.36 µmol/L

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a ceruloplasmin concentration of 0.2 g/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 200. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

High-dose hook effect: No false result occurs up to a ceruloplasmin concentration of 5 g/L.

Drugs: No interference was found at therapeutic concentrations using common drug panels. Exception: Intralipid causes artificially high ceruloplasmin results.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105553190

Ceruloplasmin (200 tests)

System‑ID 2036 001

cobas c 303, cobas c 503

Materials required (but not provided):

03555941190

Calibrator f.a.s. PAC (3 × 1 mL)

Code 20589

05117003190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 20392

05947774190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CER: ACN 20360

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R3

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

8.3 µL

10 µL

100 µL

Decreased

8.3 µL

2.5 µL

80 µL

Increased

8.3 µL

10 µL

100 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

8 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. PAC

Calibration mode

Non-linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).

LREFBaudner S, Bienvenu J, Blirup-Jensen S, et al. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins CRM470. Report EUR 15243 EN 1993;1-186.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Repeatability

Mean
g/L

SD
g/L

CV
%

PCCC1a)

0.169

0.00104

0.6

PCCC2b)

0.289

0.00126

0.4

Human serum 1

0.0866

0.000962

1.1

Human serum 2

0.370

0.00173

0.5

Human serum 3

0.600

0.00344

0.6

Human serum 4

0.693

0.00462

0.7

Human serum 5

1.18

0.0106

0.9

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.169

0.00215

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

0.294

0.00275

0.9

Human serum 1

0.0866

0.00241

2.8

Human serum 2

0.371

0.00285

0.8

Human serum 3

0.600

0.00408

0.7

Human serum 4

0.700

0.00579

0.8

Human serum 5

1.19

0.0135

1.1

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Ceruloplasmin values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 86

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.957x + 0.0164 g/L

y = 0.970x + 0.0138 g/L

τ = 0.967

r = 0.999

The sample concentrations were between 0.033 and 1.40 g/L.

Ceruloplasmin values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 65

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.963x + 0.0140 g/L

y = 1.004x + 0.00516 g/L

τ = 0.964

r = 0.998

The sample concentrations were between 0.0520 and 1.30 g/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:227-228.
,
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.
,
LREFSternlieb I. Copper and the liver. Gastroenterology 1980;78:1615-1628.

Ceruloplasmin is an acute phase protein and transport protein. The blue‑colored glycoprotein belongs to the α2‑globulin electrophoretic fraction and contains 8 copper atoms per molecule.

Incorporation of copper into the structure occurs during the synthesis of ceruloplasmin in the hepatocytes. After secretion from the liver, ceruloplasmin migrates to copper‑requiring tissue where the copper is liberated during catabolism of the ceruloplasmin molecule. In addition to transporting copper, ceruloplasmin has a catalytic function in the oxidation of iron (Fe2+ to Fe3+), polyamines, catecholamines, and polyphenols.

Decreased concentrations occur during recessive autosomal hepatolenticular degeneration (Wilson's disease). On a pathochemical level, the disease, which is accompanied by lower ceruloplasmin synthesis, occurs as a consequence of missing Cu2+ incorporation into the molecule due to defective metallothionine. This results in pathological deposits of copper in the liver (with accompanying development of cirrhosis), brain (with neurological symptoms), cornea (Kayser‑Fleischer ring), and kidneys (hematuria, proteinuria, aminoaciduria). In homozygous carriers, ceruloplasmin levels are severely depressed. Heterozygous carriers exhibit either no decrease at all or just a mild decrease. The rare Menke's syndrome involves a genetically caused copper absorption disorder with concomitant lowering of the ceruloplasmin level. Protein loss syndromes and liver cell failures are the most important causes of acquired ceruloplasmin depressions. As ceruloplasmin is a sensitive reactant to the acute phase, increases occur during acute and chronic inflammatory processes. Great increases can lead to a green‑blue coloration of the sera. Methods for assaying ceruloplasmin include immunodiffusion, nephelometry and turbidimetry.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Accelerator
Polyethylene glycol (PEG): 50 g/L; phosphate buffer; preservative

R3

Anti‑ceruloplasmin T antiserum (rabbit) specific for human ceruloplasmin: > 0.42 g/L; phosphate buffer; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 8 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

8 days at 20‑25 °C

2 weeks at 4‑8 °C

1 year at −20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008105553190c503", "ProductName": "CERU", "ProductLongName": "Ceruloplasmin", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF00000004743B0E", "DocumentOriginID": "FF000000038DDA0E", "MaterialNumbers": [ "08105553190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.

Immunoturbidimetric assay

Human ceruloplasmin forms a precipitate with a specific antiserum which is determined turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.03‑1.4 g/L (0.22‑10.44 µmol/L)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 3.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.03 g/L (0.22 µmol/L)

Limit of Detection

= 0.03 g/L (0.22 µmol/L)

Limit of Quantitation

= 0.03 g/L (0.22 µmol/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration ceruloplasmin samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values

g/L

Male:

0.15‑0.30 g/L

Female:

0.16‑0.45 g/L

µmol/L*

Male:

1.12‑2.24 µmol/L

Female:

1.19‑3.36 µmol/L

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a ceruloplasmin concentration of 0.2 g/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 200. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

High-dose hook effect: No false result occurs up to a ceruloplasmin concentration of 5 g/L.

Drugs: No interference was found at therapeutic concentrations using common drug panels. Exception: Intralipid causes artificially high ceruloplasmin results.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105553 190

Ceruloplasmin (200 tests)

System‑ID 2036 001

Roche/Hitachi cobas c 503

Materials required (but not provided):

03555941 190

Calibrator f.a.s. PAC (3 × 1 mL)

Code 20589

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 20391

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05947626 160

PreciControl ClinChem Multi 1 (4 × 5 mL, for USA)

Code 20391

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

05947774 160

PreciControl ClinChem Multi 2 (4 × 5 mL, for USA)

Code 20392

08063494 190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CER: ACN 20360

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R3

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

8.3 µL

10 µL

100 µL

Decreased

8.3 µL

2.5 µL

80 µL

Increased

8.3 µL

10 µL

100 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

8 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. PAC

Calibration mode

Non-linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).

LREFBaudner S, Bienvenu J, Blirup-Jensen S, et al. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins CRM470. Report EUR 15243 EN 1993;1-186.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

Repeatability

Mean
g/L

SD
g/L

CV
%

PCCC1a)

0.169

0.00104

0.6

PCCC2b)

0.289

0.00126

0.4

Human serum 1

0.0866

0.000962

1.1

Human serum 2

0.370

0.00173

0.5

Human serum 3

0.600

0.00344

0.6

Human serum 4

0.693

0.00462

0.7

Human serum 5

1.18

0.0106

0.9

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.169

0.00215

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

0.294

0.00275

0.9

Human serum 1

0.0866

0.00241

2.8

Human serum 2

0.371

0.00285

0.8

Human serum 3

0.600

0.00408

0.7

Human serum 4

0.700

0.00579

0.8

Human serum 5

1.19

0.0135

1.1

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Ceruloplasmin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 86

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.957x + 0.0164 g/L

y = 0.970x + 0.0138 g/L

τ = 0.967

r = 0.999

The sample concentrations were between 0.033 and 1.40 g/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:227-228.
,
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.
,
LREFSternlieb I. Copper and the liver. Gastroenterology 1980;78:1615-1628.

Ceruloplasmin is an acute phase protein and transport protein. The blue‑colored glycoprotein belongs to the α2‑globulin electrophoretic fraction and contains 8 copper atoms per molecule.

Incorporation of copper into the structure occurs during the synthesis of ceruloplasmin in the hepatocytes. After secretion from the liver, ceruloplasmin migrates to copper‑requiring tissue where the copper is liberated during catabolism of the ceruloplasmin molecule. In addition to transporting copper, ceruloplasmin has a catalytic function in the oxidation of iron (Fe2+ to Fe3+), polyamines, catecholamines, and polyphenols.

Decreased concentrations occur during recessive autosomal hepatolenticular degeneration (Wilson's disease). On a pathochemical level, the disease, which is accompanied by lower ceruloplasmin synthesis, occurs as a consequence of missing Cu2+ incorporation into the molecule due to defective metallothionine. This results in pathological deposits of copper in the liver (with accompanying development of cirrhosis), brain (with neurological symptoms), cornea (Kayser‑Fleischer ring), and kidneys (hematuria, proteinuria, aminoaciduria). In homozygous carriers, ceruloplasmin levels are severely depressed. Heterozygous carriers exhibit either no decrease at all or just a mild decrease. The rare Menke's syndrome involves a genetically caused copper absorption disorder with concomitant lowering of the ceruloplasmin level. Protein loss syndromes and liver cell failures are the most important causes of acquired ceruloplasmin depressions. As ceruloplasmin is a sensitive reactant to the acute phase, increases occur during acute and chronic inflammatory processes. Great increases can lead to a green‑blue coloration of the sera. Methods for assaying ceruloplasmin include immunodiffusion, nephelometry and turbidimetry.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Accelerator
Polyethylene glycol (PEG): 50 g/L; phosphate buffer; preservative

R3

Anti‑ceruloplasmin T antiserum (rabbit) specific for human ceruloplasmin: > 0.42 g/L; phosphate buffer; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 8 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

8 days at 20‑25 °C

2 weeks at 4‑8 °C

1 year at −20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0020764663322COIN", "ProductName": "CERU", "ProductLongName": "Ceruloplasmin", "Language": "en", "DocumentVersion": "10", "DocumentObjectID": "FF0000000473E30E", "DocumentOriginID": "FF00000000F3470E", "MaterialNumbers": [ "20764663322" ], "InstrumentReferences": [ { "ID": "302", "BrandName": "COBAS INTEGRA 400 plus" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFHalls DJ, Fell GS, Dunbar PM. Determination of copper in urine by graphite furnace atomic absorption spectrometry. Clin Chim Acta 1981;114:21-27.

Immunoturbidimetric assay.

Human ceruloplasmin forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.08‑1.4 g/L (0.597‑10.4 μmol/L or 8.00‑140 mg/dL) (typical measuring range)

The upper and lower limits of the measuring range depend on the actual calibrator value.

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 3.

Lower limits of measurement

Lower detection limit of the test:
0.03 g/L (0.224 μmol/L or 3.00 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of a zero sample (zero sample + 3 SD, repeatability, n = 30).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFData on file at Roche Diagnostics.

Male: 0.15‑0.30 g/L (15.0‑30.0 mg/dL or 1.12‑2.24 μmol/L)

Female: 0.16‑0.45 g/L (16.0‑45.0 mg/dL or 1.19‑3.36 μmol/L)

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 50. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug Effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Exception: Intralipid causes artificially high ceruloplasmin results.

Rheumatoid factors: No significant interference up to a rheumatoid factors level of 400 IU/mL.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

Orderinformation_INT

Order information

Analyzer(s) on which cobas c pack(s) can be used

20764663 322

Ceruloplasmin (100 tests)

System‑ID 07 6466 3

COBAS INTEGRA 400 plus

Materials required (but not provided):

03555941 190

Calibrator f.a.s. PAC (3 × 1 mL)

System‑ID 07 6810 3

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

System-ID 07 7469 3

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

System-ID 07 7469 3

05947626 160

PreciControl ClinChem Multi 1 (4 × 5 mL, for USA)

System-ID 07 7469 3

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

System-ID 07 7470 7

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

System-ID 07 7470 7

05947774 160

PreciControl ClinChem Multi 2 (4 × 5 mL, for USA)

System-ID 07 7470 7

20756350 322

NaCl Diluent 9 % (6 × 22 mL)

System‑ID 07 5635 0

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

Test CERU3, test ID 0‑666

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Measuring mode

Absorbance

Abs. calculation mode

Endpoint

Reaction mode

D-R1-S-SR

Reaction direction

Increase

Wavelength A

340 nm

Calc. first/last

33/55

Typical prozone effect

> 12.8 g/L (> 1280 mg/dL or > 95.5 µmol/L)

Antigen excess check

No

Predilution factor

21

Unit

g/L

Pipetting parameters

Diluent (H2O)

R1

100 µL

Sample

20 µL

5 µL

SR

20 µL

5 µL

Total volume

150 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C

See expiration date on cobas c pack label

On-board in use at 10‑15 °C

8 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrator

C.f.a.s. PAC

Calibration dilution ratio

1:6.3, 1:8.5, 1:11, 1:21, 1:40, 1:105, performed automatically by the instrument

Calibration mode

Logit/log 5

Calibration replicate

Duplicate recommended

Calibration interval

Each lot and as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Enter the assigned lot‑specific ceruloplasmin value of the undiluted calibrator indicated in the package insert for C.f.a.s. PAC.

Traceability: This method has been standardized against the IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) for 14 serum proteins.

LREFWhicher JT, Ritchie RF, Johnson AM, et al. New international reference preparation for proteins in human serum (RPPHS). Clin Chem 1994;40:934-938.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability and intermediate precision (2 aliquots per run, 2 runs per day, 20 days). The following results were obtained:

Level 1

Level 2

Mean

0.20 g/L
(1.52 µmol/L or 20.4 mg/dL)

0.35 g/L
(2.59 µmol/L or 34.7 mg/dL)

CV repeatability

3.6 %

2.4 %

CV intermediate precision

3.9 %

2.7 %

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Ceruloplasmin values for human serum samples obtained on a COBAS INTEGRA 400 analyzer (x) with the COBAS INTEGRA Ceruloplasmin reagent were compared to those determined with the same reagent on a COBAS INTEGRA 800 analyzer (y) and with Tina‑quant Ceruloplasmin reagent on a Roche/Hitachi 917 instrument (y).

COBAS INTEGRA 800 analyzer

Sample size (n) = 73

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.05x - 0.005 g/L

y = 1.04x - 0.001 g/L

τ = 0.9330

r = 0.9965

SD (md 95) = 0.015

Sy.x = 0.007

The sample concentrations were between 0.08 and 0.68 g/L (0.597 and 5.07 μmol/L or 8.00 and 68.0 mg/dL).

Roche/Hitachi 917 analyzer

Sample size (n) = 82

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.05x + 0.002 g/L

y = 1.03x + 0.005 g/L

τ = 0.8886

r = 0.9917

SD (md 95) = 0.023

Sy.x = 0.010

The sample concentrations were between 0.08 and 0.68 g/L (0.597 and 5.07 μmol/L or 8.00 and 68.0 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFPoulik MD, Weiss ML. Ceruloplasmin. In: Putnam FW, ed.The Plasma Proteins, Volume II. Academic Press 1975;80-91.
,
LREFHalls DJ, Fell GS, Dunbar PM. Determination of copper in urine by graphite furnace atomic absorption spectrometry. Clin Chim Acta 1981;114:21-27.
,
LREFKasper CB, Deutsch HF. Physicochemical studies of human ceruloplasmin. J Biol Chem 1963;238:2325-2337.
,
LREFSternlieb I, Scheinberg IH. Ceruloplasmin in health and disease. Ann NY Acad Sci 1961:71-76.
,
LREFSmallwood RA, Williams HA, Rosenoer VM, et al. Liver copper levels in liver disease: studies using neutron activation analysis. Lancet 1968:1310-1313.

Ceruloplasmin is a protein with a molecular weight of 150 kDa. Each molecule can reversibly bind eight atoms of copper. Ceruloplasmin carries at least 95 % of all copper in plasma. The protein is synthesized by the liver and shows an acute phase response. Decreased levels are found in primary biliary cirrhosis, primary biliary atresia, and in some cases of severe hepatitis. The decreased levels are due to the limitations of total liver metabolism rather than to a defect in specific ceruloplasmin synthesis. In some congenital disorders, such as Wilson’s disease, ceruloplasmin is also found to be decreased.

As ceruloplasmin is increasingly expressed during the acute‑phase response it is generally detected in elevated levels during all inflammatory diseases. In addition, raised levels are seen in reticuloendothelial neoplasia, biliary obstruction, estrogen therapy, and pregnancy.

Various methods have been described for the measurement of ceruloplasmin. The most commonly used are turbidimetry, nephelometry, and radial immunodiffusion.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Accelerator
Polyethylene glycol (PEG) 50 g/L, in phosphate buffer; preservative

SR

Anti‑ceruloplasmin T antiserum (rabbit) specific for human ceruloplasmin > 0.42 g/L in phosphate buffer; preservative

R1 is in position B and SR is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Reference range

PreciControl ClinChem Multi 1

Pathological range

PreciControl ClinChem Multi 2

Control interval

24 hours recommended

Control sequence

User defined

Control after calibration

Recommended

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Samples and controls are automatically prediluted 1:21 (1 + 20) with NaCl solution by the instrument.

Stability:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 20‑25 °C

2 weeks at 4‑8 °C

1 year at −20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0020764663322c501", "ProductName": "CERU", "ProductLongName": "Ceruloplasmin", "Language": "en", "DocumentVersion": "10", "DocumentObjectID": "FF00000001F4DC0E", "DocumentOriginID": "FF000000001E2B0E", "MaterialNumbers": [ "20764663322" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.

Immunoturbidimetric assay.

Human ceruloplasmin forms a precipitate with a specific antiserum which is determined turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.03‑1.4 g/L (0.22‑10.44 µmol/L, 3‑140 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 3.

Lower limits of measurement

Lower detection limit of the test

0.03 g/L (0.22 µmol/L, 3 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFData on file at Roche Diagnostics.

Male:

0.15‑0.30 g/L

Female:

0.16‑0.45 g/L

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of the initial value at a ceruloplasmin concentration of 0.2 g/L (1.49 µmol/L, 20 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 200. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors up to 100 IU/mL do not interfere.

High dose hook‑effect: No false result occurs up to a ceruloplasmin concentration of 5 g/L (37.3 μmol/L, 500 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Exception: Intralipid causes artificially high ceruloplasmin results.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is not required.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

20764663 322

Ceruloplasmin 100 tests

System‑ID 07 6466 3

Roche/Hitachi cobas c 311, cobas c 501/502

03555941 190

Calibrator f.a.s. PAC (3 x 1 mL)

Code 589

04567021 190

Prealbumin/Ceruloplasmin Control Set*

Precinorm PC (3 x 1 mL)

Code 102

Precipath PC (3 x 1 mL)

Code 103

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

04489357 190

Diluent NaCl 9 % (50 mL)

System‑ID 07 6869 3

*Not for use in the US; US customers should use a suitable commercially available control.

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas c 311/501 analyzers:

CER: ACN 707

For cobas c 502 analyzer:

CER: ACN 8707

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 311 test definition

Assay type

2‑Point End

Reaction time / Assay points

10/6‑25

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

11 µL

15 µL

150 µL

Decreased

11 µL

5 µL

160 µL

Increased

11 µL

15 µL

150 µL

cobas c 501 test definition

Assay type

2‑Point End

Reaction time / Assay points

10/10‑36

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

11 µL

15 µL

150 µL

Decreased

11 µL

5 µL

160 µL

Increased

11 µL

15 µL

150 µL

cobas c 502 test definition

Assay type

2‑Point End

Reaction time / Assay points

10/10‑36

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

11 µL

15 µL

150 µL

Decreased

11 µL

5 µL

160 µL

Increased

11 µL

20 µL

90 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

CERU

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

8 weeks

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

12 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. PAC

Multiply the lot‑specific C.f.a.s. PAC calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:

S2: 0.600

S5: 3.20

S3: 1.25

S6: 4.00

S4: 2.10

Calibration mode

RCM2

Calibration frequency

Full calibration
• after reagent lot change
• as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).

LREFBaudner S, Bienvenu J, Blirup-Jensen S, et al. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins CRM470. Report EUR 15243 EN 1993;1-186.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean

g/L (µmol/L, mg/dL)

SD

g/L (µmol/L, mg/dL)

CV

%

Precinorm Protein

0.283 (2.11, 28.3)

0.004 (0.03, 0.4)

1.6

Precipath Protein

0.620 (4.62, 62.0)

0.007 (0.05, 0.7)

1.1

Human serum 1

0.298 (2.23, 29.8)

0.003 (0.02, 0.25)

0.8

Human serum 2

0.501 (3.74, 50.1)

0.004 (0.03, 0.4)

0.7

Human serum 3

1.30 (9.70, 130)

0.009 (0.07, 0.9)

0.7

Intermediate precision

Mean

g/L (µmol/L, mg/dL)

SD

g/L (µmol/L, mg/dL)

CV

%

Precinorm Protein

0.293 (2.19, 293)

0.004 (0.03, 0.4)

1.4

Precipath Protein

0.413 (3.08, 41.3)

0.004 (0.03, 0.4)

1.0

Human serum 3

0.188 (1.40, 18.8)

0.005 (0.04, 0.5)

2.6

Human serum 4

0.436 (3.25, 436)

0.007 (0.05, 0.7)

1.5

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Ceruloplasmin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Sample size (n) = 82

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.980x + 0.012 g/L

y = 1.015x – 0.001 g/L

τ = 0.934

r = 0.997

The sample concentrations were between 0.132 and 1.32 g/L (0.984 and 9.85 µmol/L, 13.2 and 132 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:227-228.
,
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.
,
LREFSternlieb I. Copper and the liver. Gastroenterology 1980;78:1615-1628.

Ceruloplasmin is an acute phase protein and transport protein. The blue‑colored glycoprotein belongs to the α2‑globulin electrophoretic fraction and contains 8 copper atoms per molecule.

Incorporation of copper into the structure occurs during the synthesis of ceruloplasmin in the hepatocytes. After secretion from the liver, ceruloplasmin migrates to copper‑requiring tissue where the copper is liberated during catabolism of the ceruloplasmin molecule. In addition to transporting copper, ceruloplasmin has a catalytic function in the oxidation of iron (Fe2+ to Fe3+ ), polyamines, catecholamines, and polyphenols.

Decreased concentrations occur during recessive autosomal hepatolenticular degeneration (Wilson's disease). On a pathochemical level, the disease, which is accompanied by lower ceruloplasmin synthesis, occurs as a consequence of missing Cu2+ incorporation into the molecule due to defective metallothionine. This results in pathological deposits of copper in the liver (with accompanying development of cirrhosis), brain (with neurological symptoms), cornea (Kayser‑Fleischer ring), and kidneys (hematuria, proteinuria, aminoaciduria). In homozygous carriers, ceruloplasmin levels are severely depressed. Heterozygous carriers exhibit either no decrease at all or just a mild decrease. The rare Menke's syndrome involves a genetically caused copper absorption disorder with concomitant lowering of the ceruloplasmin level. Protein loss syndromes and liver cell failures are the most important causes of acquired ceruloplasmin depressions. As ceruloplasmin is a sensitive reactant to the acute phase, increases occur during acute and chronic inflammatory processes. Great increases can lead to a green‑blue coloration of the sera. Methods for assaying ceruloplasmin include immunodiffusion, nephelometry and turbidimetry.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Accelerator
Polyethylene glycol (PEG): 50 g/L; phosphate buffer; preservative

R2

Anti‑ceruloplasmin T antiserum (rabbit) specific for human ceruloplasmin: > 0.42 g/L; phosphate buffer; preservative

R1 is in position B and R2 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

Stability:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

8 days at 20‑25 °C

2 weeks at 4‑8 °C

1 year at -20 °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0005950848190c701", "ProductName": "CERU", "ProductLongName": "Ceruloplasmin", "Language": "en", "DocumentVersion": "7", "DocumentObjectID": "FF0000000473D70E", "DocumentOriginID": "FF000000008F4F0E", "MaterialNumbers": [ "05950848190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.

Immunoturbidimetric assay.

Human ceruloplasmin forms a precipitate with a specific antiserum which is determined turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.03‑1.4 g/L (0.22‑10.44 µmol/L, 3‑140 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 3.

Lower limits of measurement

Lower detection limit of the test

0.03 g/L (0.22 µmol/L, 3 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 0.03 g/L) will not be flagged by the instrument.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFData on file at Roche Diagnostics.

Male:

0.15‑0.30 g/L

Female:

0.16‑0.45 g/L

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of the initial value at a ceruloplasmin concentration of 0.3 g/L (2.24 µmol/L, 30 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 200. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors up to 100 IU/mL do not interfere.

High dose hook‑effect: No false result occurs up to a ceruloplasmin concentration of 5 g/L (37.3 µmol/L, 500 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Exception: Intralipid causes artificially high ceruloplasmin results.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is not required. The latest version of the carry‑over evasion list can also be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

05950848 190

Ceruloplasmin (150 tests)

System‑ID 03 6466 3

Roche/Hitachi cobas c 701/702

Materials required (but not provided):

03555941 190

Calibrator f.a.s. PAC (3 x 1 mL)

Code 589

04567021 190

Prealbumin/Ceruloplasmin Control Set*

Precinorm PC (3 x 1 mL)

Code 102

Precipath PC (3 x 1 mL)

Code 103

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

05172152 190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

*Not for use in the US; US customers should use a suitable commercially available control.

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CER: ACN 8707

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10/19‑33

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R3

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

11 µL

15 µL

150 µL

Decreased

11 µL

5 µL

160 µL

Increased

11 µL

20 µL

90 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

CERU

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2-S6: C.f.a.s. PAC

Multiply the lot‑specific C.f.a.s. PAC calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:

S2: 0.600

S5: 3.20

S3: 1.25

S6: 4.00

S4: 2.10

Calibration mode

RCM2

Calibration frequency

Full calibration
• after reagent lot change
• as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).

LREFBaudner S, Bienvenu J, Blirup-Jensen S, et al. The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins CRM470. Report EUR 15243 EN 1993;1-186.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean

g/L (µmol/L, mg/dL)

SD

g/L (µmol/L, mg/dL)

CV

%

Precinorm PC

0.299 (2.23, 29.9)

0.004 (0.03, 0.4)

1.4

Precipath PC

0.644 (4.80, 64.4)

0.006 (0.04, 0.6)

1.0

Human serum A

0.290 (2.16, 29.0)

0.005 (0.04, 0.5)

1.6

Human serum B

0.458 (3.42, 45.8)

0.004 (0.03, 0.4)

0.9

Human serum C

1.26 (9.40, 126)

0.01 (0.07, 1)

0.9

Intermediate precision

Mean

g/L (µmol/L, mg/dL)

SD

g/L (µmol/L, mg/dL)

CV

%

Precinorm Protein

0.293 (2.19, 29.3)

0.004 (0.03, 0.4)

1.4

Precipath Protein

0.413 (3.08, 41.3)

0.004 (0.03, 0.4)

1.0

Human serum 1

0.188 (1.40, 18.8)

0.005 (0.04, 0.5)

2.6

Human serum 2

0.436 (3.25, 43.6)

0.007 (0.05, 0.7)

1.5

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Ceruloplasmin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 67

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.990x - 0.008 g/L

y = 0.943x + 0.017 g/L

τ = 0.897

r = 0.989

The sample concentrations were between 0.212 and 1.15 g/L (1.58 and 8.58 µmol/L, 21.2 and 115 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:227-228.
,
LREFWolf PL. Ceruloplasmin: methods and clinical use. Crit Rev Clin Lab Sci 1982;17:229-245.
,
LREFSternlieb I. Copper and the liver. Gastroenterology 1980;78:1615-1628.

Ceruloplasmin is an acute phase protein and transport protein. The blue‑colored glycoprotein belongs to the α2‑globulin electrophoretic fraction and contains 8 copper atoms per molecule.

Incorporation of copper into the structure occurs during the synthesis of ceruloplasmin in the hepatocytes. After secretion from the liver, ceruloplasmin migrates to copper-requiring tissue where the copper is liberated during catabolism of the ceruloplasmin molecule. In addition to transporting copper, ceruloplasmin has a catalytic function in the oxidation of iron (Fe2+ to Fe3+), polyamines, catecholamines, and polyphenols.

Decreased concentrations occur during recessive autosomal hepatolenticular degeneration (Wilson's disease). On a pathochemical level, the disease, which is accompanied by lower ceruloplasmin synthesis, occurs as a consequence of missing Cu2+ incorporation into the molecule due to defective metallothionine. This results in pathological deposits of copper in the liver (with accompanying development of cirrhosis), brain (with neurological symptoms), cornea (Kayser‑Fleischer ring), and kidneys (hematuria, proteinuria, aminoaciduria). In homozygous carriers, ceruloplasmin levels are severely depressed. Heterozygous carriers exhibit either no decrease at all or just a mild decrease. The rare Menke's syndrome involves a genetically caused copper absorption disorder with concomitant lowering of the ceruloplasmin level. Protein loss syndromes and liver cell failures are the most important causes of acquired ceruloplasmin depressions. As ceruloplasmin is a sensitive reactant to the acute phase, increases occur during acute and chronic inflammatory processes. Great increases can lead to a green-blue coloration of the sera. Methods for assaying ceruloplasmin include immunodiffusion, nephelometry and turbidimetry.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Accelerator
Polyethylene glycol (PEG): 50 g/L; phosphate buffer; preservative

R3

Anti‑ceruloplasmin T antiserum (rabbit) specific for human ceruloplasmin: > 0.42 g/L; phosphate buffer; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

Stability:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

8 days at 20‑25 °C

2 weeks at 4‑8 °C

1 year at -20 °C

", "Language": "en" } ] } } ] }

CERU

Ceruloplasmin

IVD For in vitro diagnostic use.
CERU

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

    Access Material Data Sheets, Certificates of Analysis, and other product documentation.

    After clicking below, you will be redirected to eLabDoc, where you can choose your local country.
    error errorMessage
    Sorry, we couldn't find the content you are looking for
    Please try again later