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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 glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Colorimetric test by reaction with nitroblue tetrazolium.

LREFSiedel J, Vogt B, Kerscher L, et al. Serum fructosamine assay: two different color reagents compared with reference to a HPLC-procedure. Clin Chem 1988;34:1316.
,
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFSchleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990;36:136-139.

The colorimetric test for fructosamine (glycated protein) is based on the ability of ketoamines to reduce nitroblue tetrazolium in alkaline medium. The rate of formation of formazan is directly proportional to the fructosamine concentration and is measured photometrically.

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

Limits and ranges

Measuring range

14‑1000 µmol/L

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Lower detection limit of the test

14 µmol/L

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 (< 14 µmol/L) will not be flagged by the instrument.

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

Expected values

Expected values
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFMelzi d’Eril GV, Bosini T, Solerte SB, et al. Performance and clinical significance of the new fructosamine assay in diabetic patients. Wien Klin Wochenschr Suppl 1990;180:60-63.

Fructosamine concentrations were determined in 555 apparently healthy subjects between the ages of 20 and 60. A reference range of 205 to 285 µmol/L was determined in this study for adults without diabetes. In a poorly controlled diabetic population, mean fructosamine values were reported to be 396 µmol/L (range 228‑563 µmol/L). A fructosamine concentration above the established expected value is an indicator for hyperglycemia during the preceeding 1‑3 weeks or longer.

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 fructosamine concentration of 285 µmol/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 4 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 68 µmol/L or 4 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 100 (approximate hemoglobin concentration: 62 µmol/L or 100 mg/dL).

Lipemia:

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 1800. 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: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.

As tested according CLSI recommendation Methyldopa causes artificially high fructosamine results.

LREFCLSI. Interference testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI document EP7-A2, Wayne, Pennsylvania, 2005.

Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 170 µmol/L (30 mg/L).

In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:

Fructosaminecorr =

measured fructosamine × 72

measured total protein (in g/L)

Dysproteinemic states may affect fructosamine values.

LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

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 oncobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can 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

05171962 190*

Fructosamine (250 tests)

System‑ID 03 3756 9

cobas c 701/702

05171962 214*

Fructosamine (250 tests)

System‑ID 03 3756 9

cobas c 701/702

11098993 122

Precimat Fructosamine (3 x 1 mL)

Code 581

11098985 122

Precinorm Fructosamine (3 x 1 mL)

Code 321

11174118 122

Precipath Fructosamine (3 x 1 mL)

Code 322

* Some kits shown may not be available in all countries.

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

System information

FRA: ACN 8667

", "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

Rate A

Reaction time / Assay points

10/34‑38

Wavelength (sub/main)

700/546 nm

Reaction direction

Increase

Unit

µmol/L

Reagent pipetting

Diluent (H2O)

R1

60 µL

28 µL

R3

12 µL

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

6 µL

Decreased

3 µL

Increased

12 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 and refrigerated on the analyzer:

8 weeks

On‑board on the Reagent Manager:

24 hours

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

Calibration

Calibrators

S1: H2O

S2: Precimat Fructosamine

Calibration mode

Linear

Calibration frequency

2‑point calibration
- after 4 weeks on board
- 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 fructose polylysine standard.

", "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

µmol/L

SD

µmol/L

CV

%

Precinorm Fructosamine

275

2

0.8

Precipath Fructosamine

515

3

0.5

Human serum A

220

2

1.0

Human serum B

315

2

0.7

Human serum C

748

4

0.6

Intermediate precision

Mean

µmol/L

SD

µmol/L

CV

%

Precinorm Fructosamine

262

4

1.5

Precipath Fructosamine

489

6

1.2

Human serum 3

266

4

1.5

Human serum 4

210

4

1.8

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

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

Method comparison

Fructosamine values for human serum and plasma samples obtained on a cobas c 701 analyzer (y) were compared with those determined on cobas c 501 analyzers (x).

Sample size (n) = 98

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 = 0.998x + 10.1 µmol/L

y = 0.992x + 11.8 µmol/L

τ = 0.939

r = 0.998

The sample concentrations were between 104 and 765 µmol/L.

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

Summary

Summary
LREFJohnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983;127:87-95.
,
LREFArmbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987;33(12):2153-2163.
,
LREFCefalu WT, Bell-Farrow AD, Petty M, et al. Clinical validation of a second-generation fructosamine assay. Clin Chem 1991;37:1252-1256.
,
LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Fructosamine represents non-enzymatic glycation attached to blood and tissue proteins. The formation of fructosamine is a two‑step reaction, which is dependent on the glucose concentration. As a first step a Schiff Base is formed by the reversible coupling of glucose to protein which, in a second step, is transformed by non‑reversible Amadori rearrangement to the corresponding ketoamine. This ketoamine is designated as fructosamine. The formation of fructosamine increases with the level of blood glucose. Metabolization occurs within 1 to 3 weeks, corresponding to the turnover of most serum proteins. The concentration of fructosamine thus reflects the average of the continuously varying blood glucose concentrations during this period, serving as a blood glucose memory.

Fructosamine is therefore a rapid indicator of glycemia in the diagnosis and management of diabetes mellitus.

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

Reagents - working solutions

R1

Nitroblue tetrazolium: 1.2 mmol/L; uricase (microbial): ≥ 12 µkat/L; pH 7.5; non‑reactive buffer; stabilizer; surfactants

R3

Carbonate buffer: 1.5 mol/L; pH 10.4

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H315

Causes skin irritation.

H318

Causes serious eye damage.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P305 + P351 + P338
+ P310

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "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: Collect serum using standard sampling tubes.
Plasma: Li‑heparin and K2‑EDTA 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:

3 days at 15‑25 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 weeks at 2‑8 °C
LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 months at (-15)‑(-25) °C
LREFKoskinen P, Irjala K. Stability of Serum Fructosamine during Storage. Clin Chem 1988;34(12):2545-2546.

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": "0004537939190COIN", "ProductName": "FRA", "ProductLongName": "Fructosamine", "Language": "en", "DocumentVersion": "7", "DocumentObjectID": "FF00000004750A0E", "DocumentOriginID": "FF000000007DA60E", "MaterialNumbers": [ "04537939190" ], "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 determination of glycated proteins (fructosamine) in human serum and plasma on COBAS INTEGRA systems.

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

Test principle

Colorimetric test by reaction with nitroblue tetrazolium.

LREFSiedel J, Vogt B, Kerscher L, et al. Serum fructosamine assay: two different color reagents compared with reference to a HPLC-procedure. Clin Chem 1988;34:1316.
,
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFSchleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990;36:136-139.

The colorimetric test for fructosamine (glycated protein) is based on the ability of ketoamines to reduce nitroblue tetrazolium in alkaline medium. The rate of formation of formazane is directly proportional to the fructosamine concentration and is measured photometrically at 552 nm.

Measurement is made against Roche Fructosamine Calibrator which was standardized via glycated poly‑L‑lysine.

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

Limits and ranges

Measuring range

14‑900 µmol/L

Lower detection limit

Lower detection limit of the test:
14 µmol/L

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
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFMelzi d’Eril GV, Bosini T, Solerte SB, et al. Performance and clinical significance of the new fructosamine assay in diabetic patients. Wien Klin Wochenschr Suppl 1990;180:60-63.

Fructosamine concentrations were determined in 555 apparently healthy subjects between the ages of 20 and 60. A reference range of 205‑285 µmol/L was determined in this study for adults without diabetes. In a poorly controlled diabetic population, mean fructosamine values were reported to be 396 µmol/L (range 228‑563 µmol/L). A fructosamine concentration above the established expected value is an indicator for hyperglycemia during the preceeding 1‑3 weeks or longer.

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

Limitations - interference

In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:

Fructosamine corr =

measured fructosamine × 72
measured total protein (in g/L)

Dysproteinemic states may affect fructosamine values.

LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Criterion: Recovery within ± 10 % of initial value.

Serum/plasma

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 5 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 85 µmol/L or 5 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 50 (approximate hemoglobin concentration: 31 µmol/L or 50 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 2000. 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: levodopa, methyldopa, calcium dobesilate, and oxytetracycline cause artificially high fructosamine values.

Physiological ascorbic acid levels do not interfere with the fructosamine test. Ascorbic acid levels higher than 227 μmol/L (4 mg/dL) interfere with the test significantly. No significant interference up to a glucose level of 45 mmol/L (810 mg/dL).

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

04537939 190

Fructosamine (150 tests)

System-ID 07 3756 9

COBAS INTEGRA 400 plus

Materials required (but not provided):

11098993 122

Precimat Fructosamine (3 × 1 mL)

System-ID 07 9171 7

11098985 122

Precinorm Fructosamine (3 × 1 mL)

System-ID 07 9164 4

11174118 122

Precipath Fructosamine (3 × 1 mL)

System-ID 07 9170 9

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

System information

Test FRA, test ID 0‑056.

", "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

Kinetic

Reaction mode

R1‑S‑SR

Reaction direction

Increase

Wavelength A/B

552/652 nm

Calc. first/last

86/98

Unit

µmol/L

Fructosamine is measured as long analysis test (duration approximately 17 minutes).

Pipetting parameters

Diluent (H2O)

R1

60 µL

24 µL

Sample

6 µL

12 µL

SR

12 µL

12 µL

Total volume

126 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

Calibration

Calibrator

Precimat Fructosamine

Use deionized water as zero calibrator.

Calibration mode

Linear regression

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.

Traceability: This method has been standardized against fructose polylysine standard.

", "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

181 µmol/L

450 µmol/L

CV repeatability

0.92 %

0.65 %

CV intermediate precision

2.8 %

2.5 %

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

Method comparison

Fructosamine values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Fructosamine reagent (y) were compared with those determined using the commercially available reagents for fructosamine on a COBAS MIRA system and an alternative manufacturer’s clinical chemistry system (x). Samples were measured in duplicate. Sample size (n) represents all replicates.

COBAS MIRA
system

Alternative system

Sample size

(n)

148

200

Corr. coefficient

(r)

(rs)

0.993

0.990

0.995

0.991

Linear regression

y = 1.06x - 10 μmol/L

y = 0.99x - 13 μmol/L

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.

y = 1.07x - 15 μmol/L

y = 0.98x - 11 μmol/L

The sample concentrations were between 73 and 495 µmol/L.

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

Summary

Summary
LREFJohnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983;127:87-95.
,
LREFArmbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987;33:2153-2163.
,
LREFCefalu WT, Bell-Farrow AD, Petty M, et al. Clinical validation of a second-generation fructosamine assay. Clin Chem 1991;37:1252-1256.
,
LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Fructosamine represents non-enzymatic glycation attached to blood and tissue proteins. The formation of fructosamine is a two-step reaction, which is dependent on the glucose concentration. As a first step a Schiff base is formed by the reversible coupling of glucose to protein which, in a second step, is transformed by non-reversible Amadori rearrangement to the corresponding ketoamine. This ketoamine is designated as fructosamine. The formation of fructosamine increases with the level of blood glucose. Metabolization occurs within 1 to 3 weeks, corresponding to the turnover of most serum proteins. The concentration of fructosamine thus reflects the average of the continuously varying blood glucose concentrations during this period, serving as a blood glucose memory.

Fructosamine is therefore a rapid indicator of glycemia in the diagnosis and management of diabetes mellitus.

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

Reagents - working solutions

Reagents - working solutions

R1

Nitroblue tetrazolium: 1.2 mmol/L; uricase (microbial): ≥ 12 µkat/L; pH 7.5; non‑reactive buffer; stabilizer

SR

Carbonate: 1.5 mol/L; pH 10.4

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H315

Causes skin irritation.

H318

Causes serious eye damage.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P310

Immediately call a POISON CENTER /doctor.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

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

Quality control

Reference range

Precinorm Fructosamine

Pathological range

Precipath Fructosamine

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: Collect serum using standard sampling tubes.
Plasma: Li-heparin or EDTA plasma.

Collect blood by venipuncture using an evacuated tube system.

Standardized conditions for blood withdrawal are preferable.

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:

3 days at 15‑25 °C

LREFBurtis CA, Ashwood ER. Tietz Textbook of Clinical Chemistry, 3rd ed. Pa: WB Saunders Co 1999;797.

2 weeks at 2‑8 °C

LREFBurtis CA, Ashwood ER. Tietz Textbook of Clinical Chemistry, 3rd ed. Pa: WB Saunders Co 1999;797.

2 months at (‑15)‑(‑25) °C

LREFKoskinen P, Irjala K. Stability of Serum Fructosamine during Storage. Clin Chem 1988;34(12):2545-2546.

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": "0004537939190c501", "ProductName": "FRA", "ProductLongName": "Fructosamine", "Language": "en", "DocumentVersion": "10", "DocumentObjectID": "FF0000000609180E", "DocumentOriginID": "FF0000000023750E", "MaterialNumbers": [ "04537939190" ], "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 glycated proteins (fructosamine) in human serum and plasma on cobas c systems.

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

Test principle

Colorimetric test by reaction with nitroblue tetrazolium.

LREFSiedel J, Vogt B, Kerscher L, et al. Serum fructosamine assay: two different color reagents compared with reference to a HPLC-procedure. Clin Chem 1988;34:1316.
,
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFSchleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990;36:136-139.

The colorimetric test for fructosamine (glycated protein) is based on the ability of ketoamines to reduce nitroblue tetrazolium in alkaline medium. The rate of formation of formazan is directly proportional to the fructosamine concentration and is measured photometrically.

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

Limits and ranges

Measuring range

14‑1000 µmol/L

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Lower detection limit of the test

14 µmol/L

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
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFMelzi d’Eril GV, Bosini T, Solerte SB, et al. Performance and clinical significance of the new fructosamine assay in diabetic patients. Wien Klin Wochenschr Suppl 1990;180:60-63.

Fructosamine concentrations were determined in 555 apparently healthy subjects between the ages of 20 and 60. A reference range of 205 to 285 µmol/L was determined in this study for adults without diabetes. In a poorly controlled diabetic population, mean fructosamine values were reported to be 396 µmol/L (range 228‑563 µmol/L). A fructosamine concentration above the established expected value is an indicator for hyperglycemia during the preceeding 1‑3 weeks or longer.

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 fructosamine concentration of 285 µmol/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 4 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 68 µmol/L or 4 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 100 (approximate hemoglobin concentration: 62 µmol/L or 100 mg/dL).

Lipemia:

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 1800. 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: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.

As tested according CLSI recommendation Methyldopa causes artificially high fructosamine results.

LREFCLSI. Interference testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI document EP7-A2, Wayne, Pennsylvania, 2005.

Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 99.4 µmol/L (17.5 mg/L).

In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:

Fructosaminecorr=

measured fructosamine × 72

measured total protein (in g/L)

Dysproteinemic states may affect fructosamine values.

LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

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. 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 required in certain cases.

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

04537939190

Fructosamine (150 tests)

System‑ID 07 3756 9

cobas c 311, cobas c 501/502

Materials required (but not provided):

11098993122

Precimat Fructosamine (3 x 1 mL)

Code 581

11098985122

Precinorm Fructosamine (3 x 1 mL)

Code 321

11174118122

Precipath Fructosamine (3 x 1 mL)

Code 322

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

System information

For cobas c 311/501 analyzers:

FRA: ACN 667

For cobas c 502 analyzer:

FRA: ACN 8667

", "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

Rate A

Reaction time / Assay points

10 / 52‑57

Wavelength (sub/main)

700/546 nm

Reaction direction

Increase

Unit

µmol/L

Reagent pipetting

Diluent (H2O)

R1

60 µL

28 µL

R2

12 µL

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

6 µL

Decreased

3 µL

Increased

6 µL

cobas c 501 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 63‑70

Wavelength (sub/main)

700/546 nm

Reaction direction

Increase

Unit

µmol/L

Reagent pipetting

Diluent (H2O)

R1

60 µL

28 µL

R2

12 µL

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

6 µL

Decreased

3 µL

Increased

6 µL

cobas c 502 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 63‑70

Wavelength (sub/main)

700/546 nm

Reaction direction

Increase

Unit

µmol/L

Reagent pipetting

Diluent (H2O)

R1

60 µL

28 µL

R2

12 µL

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

6 µL

Decreased

3 µL

Increased

12 µL

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

Storage and stability

FRA

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: Precimat Fructosamine

Calibration mode

Linear

Calibration frequency

2‑point 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 fructose polylysine standard.

", "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

µmol/L

SD

µmol/L

CV

%

Precinorm Fructosamine

262

4

1.6

Precipath Fructosamine

498

4

0.7

Human serum 1

262

2

0.9

Human serum 2

208

2

1.0

Intermediate precision

Mean

µmol/L

SD

µmol/L

CV

%

Precinorm Fructosamine

262

4

1.5

Precipath Fructosamine

489

6

1.2

Human serum 3

266

4

1.5

Human serum 4

210

4

1.8

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

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

Method comparison

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

Sample size (n) = 231

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 = 0.968x + 15.0 µmol/L

y = 0.967x + 15.5 µmol/L

τ = 0.946

r = 0.998

The sample concentrations were between 166 and 836 µmol/L.

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

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

Summary

Summary
LREFJohnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983;127:87-95.
,
LREFArmbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987;33(12):2153-2163.
,
LREFCefalu WT, Bell-Farrow AD, Petty M, et al. Clinical validation of a second-generation fructosamine assay. Clin Chem 1991;37:1252-1256.
,
LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Fructosamine represents non‑enzymatic glycation attached to blood and tissue proteins. The formation of fructosamine is a two‑step reaction, which is dependent on the glucose concentration. As a first step a Schiff Base is formed by the reversible coupling of glucose to protein which, in a second step, is transformed by non‑reversible Amadori rearrangement to the corresponding ketoamine. This ketoamine is designated as fructosamine. The formation of fructosamine increases with the level of blood glucose. Metabolization occurs within 1 to 3 weeks, corresponding to the turnover of most serum proteins. The concentration of fructosamine thus reflects the average of the continuously varying blood glucose concentrations during this period, serving as a blood glucose memory.

Fructosamine is therefore a rapid indicator of glycemia in the diagnosis and management of diabetes mellitus.

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

Reagents - working solutions

R1

Nitroblue tetrazolium: 1.2 mmol/L; uricase (microbial): ≥ 12 µkat/L; pH 7.5; non‑reactive buffer; stabilizer; surfactants

R2

Carbonate buffer: 1.5 mol/L; pH 10.4

R1 is in position B and R2 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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H315

Causes skin irritation.

H318

Causes serious eye damage.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P305 + P351 + P338
+ P310

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "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: Collect serum using standard sampling tubes.
Plasma: Li‑heparin and K2‑EDTA 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.

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.

Stability:

3 days at 15‑25 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 weeks at 2‑8 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 months at (-15)‑(-25) °C

LREFKoskinen P, Irjala K. Stability of Serum Fructosamine during Storage. Clin Chem 1988;34(12):2545-2546.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008105677190c503", "ProductName": "FRA", "ProductLongName": "Fructosamine", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF000000038FDB0E", "DocumentOriginID": "FF000000038FDA0E", "MaterialNumbers": [ "08105677190" ], "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 glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Colorimetric test by reaction with nitroblue tetrazolium.

LREFSiedel J, Vogt B, Kerscher L, et al. Serum fructosamine assay: two different color reagents compared with reference to a HPLC-procedure. Clin Chem 1988;34:1316.
,
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFSchleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990;36:136-139.

The colorimetric test for fructosamine (glycated protein) is based on the ability of ketoamines to reduce nitroblue tetrazolium in alkaline medium. The rate of formation of formazan is directly proportional to the fructosamine concentration and is measured photometrically.

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

Limits and ranges

Measuring range

14‑1000 µmol/L

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 14 µmol/L

Limit of Detection

= 14 µmol/L

Limit of Quantitation

= 14 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 fructosamine samples.

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

Expected values

Expected values
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFMelzi d’Eril GV, Bosini T, Solerte SB, et al. Performance and clinical significance of the new fructosamine assay in diabetic patients. Wien Klin Wochenschr Suppl 1990;180:60-63.

Fructosamine concentrations were determined in 555 apparently healthy subjects between the ages of 20 and 60. A reference range of 205 to 285 µmol/L was determined in this study for adults without diabetes. In a poorly controlled diabetic population, mean fructosamine values were reported to be 396 µmol/L (range 228‑563 µmol/L). A fructosamine concentration above the established expected value is an indicator for hyperglycemia during the preceeding 1‑3 weeks or longer.

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 fructosamine concentration of 285 µmol/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 5 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 85 µmol/L or 5 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 100 (approximate hemoglobin concentration: 62 µmol/L or 100 mg/dL).

Lipemia:

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 1800. 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: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.

As tested according to CLSI recommendation methyldopa causes artificially high fructosamine results.

LREFCLSI. Interference testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI document EP7-A2, Wayne, Pennsylvania, 2005.

Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 170 µmol/L (30 mg/L).

In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:

Fructosaminecorr =

measured fructosamine × 72

measured total protein (in g/L)

Dysproteinemic states may affect fructosamine values.

LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

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

08105677 190

Fructosamine (550 tests)

System‑ID 2058 001

Roche/Hitachi cobas c 503

11098993 122

Precimat Fructosamine (3 x 1 mL)

Code 20581

11098985 122

Precinorm Fructosamine (3 x 1 mL)

Code 20321

11174118 122

Precipath Fructosamine (3 x 1 mL)

Code 20322

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

System information

FRA: ACN 20580

", "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)

700/546 nm

Reagent pipetting

Diluent (H2O)

R1

45 µL

21 µL

R3

9 µL

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4.5 µL

Decreased

2.3 µL

Increased

4.5 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: Precimat Fructosamine

Calibration mode

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 fructose polylysine standard.

", "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
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

270

1.81

0.7

Precipath Fructosamine

527

3.07

0.6

Human serum 1

45.5

1.64

3.6

Human serum 2

109

1.30

1.2

Human serum 3

299

1.73

0.6

Human serum 4

526

3.63

0.7

Human serum 5

937

4.53

0.5

Intermediate precision

Mean
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

269

3.10

1.1

Precipath Fructosamine

526

6.16

1.2

Human serum 1

45.5

1.67

3.7

Human serum 2

109

1.63

1.5

Human serum 3

302

2.25

0.7

Human serum 4

526

5.30

1.0

Human serum 5

937

8.55

0.9

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

Method comparison

Fructosamine 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) = 75

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 = 0.976x + 19.6 µmol/L

y = 0.972x + 19.8 µmol/L

τ = 0.920

r = 0.998

The sample concentrations were between 19.1 and 960 µmol/L.

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

Summary

Summary
LREFJohnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983;127:87-95.
,
LREFArmbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987;33(12):2153-2163.
,
LREFCefalu WT, Bell-Farrow AD, Petty M, et al. Clinical validation of a second-generation fructosamine assay. Clin Chem 1991;37:1252-1256.
,
LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Fructosamine represents non‑enzymatic glycation attached to blood and tissue proteins. The formation of fructosamine is a two‑step reaction, which is dependent on the glucose concentration. As a first step a Schiff base is formed by the reversible coupling of glucose to protein which, in a second step, is transformed by non‑reversible Amadori rearrangement to the corresponding ketoamine. This ketoamine is designated as fructosamine. The formation of fructosamine increases with the level of blood glucose. Metabolization occurs within 1 to 3 weeks, corresponding to the turnover of most serum proteins. The concentration of fructosamine thus reflects the average of the continuously varying blood glucose concentrations during this period, serving as a blood glucose memory.

Fructosamine is therefore a rapid indicator of glycemia in the diagnosis and management of diabetes mellitus.

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

Reagents - working solutions

R1

Nitroblue tetrazolium: 1.2 mmol/L; uricase (microbial): ≥ 12 µkat/L; pH 7.5; non‑reactive buffer; stabilizer; surfactants

R3

Carbonate buffer: 1.5 mol/L; pH 10.4

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H315

Causes skin irritation.

H318

Causes serious eye damage.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P305 + P351 + P338
+ P310

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "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: Collect serum using standard sampling tubes.
Plasma: Li‑heparin and K2‑EDTA 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.

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.

Stability:

3 days at 15‑25 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 weeks at 2‑8 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 months at (-15)‑(-25) °C

LREFKoskinen P, Irjala K. Stability of Serum Fructosamine during Storage. Clin Chem 1988;34(12):2545-2546.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108105677190c503", "ProductName": "FRA", "ProductLongName": "Fructosamine", "Language": "en", "DocumentVersion": "5", "DocumentObjectID": "FF0000000609650E", "DocumentOriginID": "FF00000004BCA00E", "MaterialNumbers": [ "08105677190" ], "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 glycated proteins (fructosamine) in human serum and plasma on cobas c systems.

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

Test principle

Colorimetric test by reaction with nitroblue tetrazolium.

LREFSiedel J, Vogt B, Kerscher L, et al. Serum fructosamine assay: two different color reagents compared with reference to a HPLC-procedure. Clin Chem 1988;34:1316.
,
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFSchleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990;36:136-139.

The colorimetric test for fructosamine (glycated protein) is based on the ability of ketoamines to reduce nitroblue tetrazolium in alkaline medium. The rate of formation of formazan is directly proportional to the fructosamine concentration and is measured photometrically.

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

Limits and ranges

Measuring range

14‑1000 µmol/L

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 14 µmol/L

Limit of Detection

= 14 µmol/L

Limit of Quantitation

= 14 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 fructosamine samples.

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

Expected values

Expected values
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFMelzi d’Eril GV, Bosini T, Solerte SB, et al. Performance and clinical significance of the new fructosamine assay in diabetic patients. Wien Klin Wochenschr Suppl 1990;180:60-63.

Fructosamine concentrations were determined in 555 apparently healthy subjects between the ages of 20 and 60. A reference range of 205 to 285 µmol/L was determined in this study for adults without diabetes. In a poorly controlled diabetic population, mean fructosamine values were reported to be 396 µmol/L (range 228‑563 µmol/L). A fructosamine concentration above the established expected value is an indicator for hyperglycemia during the preceeding 1‑3 weeks or longer.

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 fructosamine concentration of 285 µmol/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 4 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 68 µmol/L or 4 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 100 (approximate hemoglobin concentration: 62 µmol/L or 100 mg/dL).

Lipemia:

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 1800. 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: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.

As tested according to CLSI recommendation methyldopa causes artificially high fructosamine results.

LREFCLSI. Interference testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI document EP7-A2, Wayne, Pennsylvania, 2005.

Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 99.4 µmol/L (17.5 mg/L).

In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:

Fructosaminecorr =

measured fructosamine × 72

measured total protein (in g/L)

Dysproteinemic states may affect fructosamine values.

LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

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

08105677190

Fructosamine (550 tests)

System‑ID 2058 001

cobas c 303, cobas c 503

Materials required (but not provided):

11098993122

Precimat Fructosamine (3 x 1 mL)

Code 20581

11098985122

Precinorm Fructosamine (3 x 1 mL)

Code 20321

11174118122

Precipath Fructosamine (3 x 1 mL)

Code 20322

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

System information

FRA: ACN 20580

", "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)

700/546 nm

Reagent pipetting

Diluent (H2O)

R1

45 µL

21 µL

R3

9 µL

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4.5 µL

Decreased

2.3 µL

Increased

4.5 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: Precimat Fructosamine

Calibration mode

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 fructose polylysine standard.

", "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
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

270

1.81

0.7

Precipath Fructosamine

527

3.07

0.6

Human serum 1

45.5

1.64

3.6

Human serum 2

109

1.30

1.2

Human serum 3

299

1.73

0.6

Human serum 4

526

3.63

0.7

Human serum 5

937

4.53

0.5

Intermediate precision

Mean
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

269

3.10

1.1

Precipath Fructosamine

526

6.16

1.2

Human serum 1

45.5

1.67

3.7

Human serum 2

109

1.63

1.5

Human serum 3

302

2.25

0.7

Human serum 4

526

5.30

1.0

Human serum 5

937

8.55

0.9

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

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

Method comparison

Fructosamine 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) = 75

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 = 0.976x + 19.6 µmol/L

y = 0.972x + 19.8 µmol/L

τ = 0.920

r = 0.998

The sample concentrations were between 19.1 and 960 µmol/L.

Fructosamine 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) = 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 = 1.015x + 13.0 µmol/L

y = 1.019x + 11.7 µmol/L

τ = 0.949

r = 0.998

The sample concentrations were between 27.9 and 969 µmol/L.

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

Summary

Summary
LREFJohnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983;127:87-95.
,
LREFArmbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987;33(12):2153-2163.
,
LREFCefalu WT, Bell-Farrow AD, Petty M, et al. Clinical validation of a second-generation fructosamine assay. Clin Chem 1991;37:1252-1256.
,
LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Fructosamine represents non‑enzymatic glycation attached to blood and tissue proteins. The formation of fructosamine is a two‑step reaction, which is dependent on the glucose concentration. As a first step a Schiff base is formed by the reversible coupling of glucose to protein which, in a second step, is transformed by non‑reversible Amadori rearrangement to the corresponding ketoamine. This ketoamine is designated as fructosamine. The formation of fructosamine increases with the level of blood glucose. Metabolization occurs within 1 to 3 weeks, corresponding to the turnover of most serum proteins. The concentration of fructosamine thus reflects the average of the continuously varying blood glucose concentrations during this period, serving as a blood glucose memory.

Fructosamine is therefore a rapid indicator of glycemia in the diagnosis and management of diabetes mellitus.

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

Reagents - working solutions

R1

Nitroblue tetrazolium: 1.2 mmol/L; uricase (microbial): ≥ 12 µkat/L; pH 7.5; non‑reactive buffer; stabilizer; surfactants

R3

Carbonate buffer: 1.5 mol/L; pH 10.4

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H315

Causes skin irritation.

H318

Causes serious eye damage.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P305 + P351 + P338
+ P310

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590

", "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: Collect serum using standard sampling tubes.
Plasma: Li‑heparin and K2‑EDTA 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:

3 days at 15‑25 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 weeks at 2‑8 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 months at (-15)‑(-25) °C

LREFKoskinen P, Irjala K. Stability of Serum Fructosamine during Storage. Clin Chem 1988;34(12):2545-2546.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208105677190c503", "ProductName": "FRA", "ProductLongName": "Fructosamine", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF000000060B8A0E", "DocumentOriginID": "FF00000005BD450E", "MaterialNumbers": [ "08105677190" ], "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 glycated proteins (fructosamine) in human serum and plasma on cobas c systems.

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

Test principle

Colorimetric test by reaction with nitroblue tetrazolium.

LREFSiedel J, Vogt B, Kerscher L, et al. Serum fructosamine assay: two different color reagents compared with reference to a HPLC-procedure. Clin Chem 1988;34:1316.
,
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFSchleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990;36:136-139.

The colorimetric test for fructosamine (glycated protein) is based on the ability of ketoamines to reduce nitroblue tetrazolium in alkaline medium. The rate of formation of formazan is directly proportional to the fructosamine concentration and is measured photometrically.

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

Limits and ranges

Measuring range

14‑1000 µmol/L

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 14 µmol/L

Limit of Detection

= 14 µmol/L

Limit of Quantitation

= 14 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 fructosamine samples.

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

Expected values

Expected values
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFMelzi d’Eril GV, Bosini T, Solerte SB, et al. Performance and clinical significance of the new fructosamine assay in diabetic patients. Wien Klin Wochenschr Suppl 1990;180:60-63.

Fructosamine concentrations were determined in 555 apparently healthy subjects between the ages of 20 and 60. A reference range of 205 to 285 µmol/L was determined in this study for adults without diabetes. In a poorly controlled diabetic population, mean fructosamine values were reported to be 396 µmol/L (range 228‑563 µmol/L). A fructosamine concentration above the established expected value is an indicator for hyperglycemia during the preceeding 1‑3 weeks or longer.

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 fructosamine concentration of 285 µmol/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 4 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 68 µmol/L or 4 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 100 (approximate hemoglobin concentration: 62 µmol/L or 100 mg/dL).

Lipemia:

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 1800. 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: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.

As tested according to CLSI recommendation methyldopa causes artificially high fructosamine results.

LREFCLSI. Interference testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI document EP7-A2, Wayne, Pennsylvania, 2005.

Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 99.4 µmol/L (17.5 mg/L).

In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:

Fructosaminecorr =

measured fructosamine × 72

measured total protein (in g/L)

Dysproteinemic states may affect fructosamine values.

LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

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

08105677190

Fructosamine (550 tests)

System‑ID 2058 001

cobas c 303, cobas c 503

Materials required (but not provided):

Order information

11098993122

Precimat Fructosamine (3 x 1 mL)

Code 20581

11098985122

Precinorm Fructosamine (3 x 1 mL)

Code 20321

11174118122

Precipath Fructosamine (3 x 1 mL)

Code 20322

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

System information

FRA: ACN 20580

", "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)

700/546 nm

Reagent pipetting

Diluent (H2O)

R1

45 µL

21 µL

R3

9 µL

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4.5 µL

Decreased

2.3 µL

Increased

4.5 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: Precimat Fructosamine

Calibration mode

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 fructose polylysine standard.

", "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
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

270

1.81

0.7

Precipath Fructosamine

527

3.07

0.6

Human serum 1

45.5

1.64

3.6

Human serum 2

109

1.30

1.2

Human serum 3

299

1.73

0.6

Human serum 4

526

3.63

0.7

Human serum 5

937

4.53

0.5

Intermediate precision

Mean
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

269

3.10

1.1

Precipath Fructosamine

526

6.16

1.2

Human serum 1

45.5

1.67

3.7

Human serum 2

109

1.63

1.5

Human serum 3

302

2.25

0.7

Human serum 4

526

5.30

1.0

Human serum 5

937

8.55

0.9

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

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

Method comparison

Fructosamine 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) = 75

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 = 0.976x + 19.6 µmol/L

y = 0.972x + 19.8 µmol/L

τ = 0.920

r = 0.998

The sample concentrations were between 19.1 and 960 µmol/L.

Fructosamine 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) = 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 = 1.015x + 13.0 µmol/L

y = 1.019x + 11.7 µmol/L

τ = 0.949

r = 0.998

The sample concentrations were between 27.9 and 969 µmol/L.

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

Summary

Summary
LREFJohnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983;127:87-95.
,
LREFArmbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987;33(12):2153-2163.
,
LREFCefalu WT, Bell-Farrow AD, Petty M, et al. Clinical validation of a second-generation fructosamine assay. Clin Chem 1991;37:1252-1256.
,
LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Fructosamine represents non‑enzymatic glycation attached to blood and tissue proteins. The formation of fructosamine is a two‑step reaction, which is dependent on the glucose concentration. As a first step a Schiff base is formed by the reversible coupling of glucose to protein which, in a second step, is transformed by non‑reversible Amadori rearrangement to the corresponding ketoamine. This ketoamine is designated as fructosamine. The formation of fructosamine increases with the level of blood glucose. Metabolization occurs within 1 to 3 weeks, corresponding to the turnover of most serum proteins. The concentration of fructosamine thus reflects the average of the continuously varying blood glucose concentrations during this period, serving as a blood glucose memory.

Fructosamine is therefore a rapid indicator of glycemia in the diagnosis and management of diabetes mellitus.

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

Reagents - working solutions

R1

Nitroblue tetrazolium: 1.2 mmol/L; uricase (microbial): ≥ 12 µkat/L; pH 7.5; non‑reactive buffer; stabilizer; surfactants

R3

Carbonate buffer: 1.5 mol/L; pH 10.4

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H315

Causes skin irritation.

H318

Causes serious eye damage.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P305 + P351 + P338
+ P310

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

", "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: Collect serum using standard sampling tubes.
Plasma: Li‑heparin and K2‑EDTA 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.

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.

Stability:

3 days at 15‑25 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 weeks at 2‑8 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 months at (-15)‑(-25) °C

LREFKoskinen P, Irjala K. Stability of Serum Fructosamine during Storage. Clin Chem 1988;34(12):2545-2546.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008105677190c503", "ProductName": "FRA", "ProductLongName": "Fructosamine", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF0000000475260E", "DocumentOriginID": "FF000000038FDB0E", "MaterialNumbers": [ "08105677190" ], "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 glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Colorimetric test by reaction with nitroblue tetrazolium.

LREFSiedel J, Vogt B, Kerscher L, et al. Serum fructosamine assay: two different color reagents compared with reference to a HPLC-procedure. Clin Chem 1988;34:1316.
,
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFSchleicher ED, Vogt BW. Standardization of serum fructosamine assays. Clin Chem 1990;36:136-139.

The colorimetric test for fructosamine (glycated protein) is based on the ability of ketoamines to reduce nitroblue tetrazolium in alkaline medium. The rate of formation of formazan is directly proportional to the fructosamine concentration and is measured photometrically.

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

Limits and ranges

Measuring range

14‑1000 µmol/L

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 14 µmol/L

Limit of Detection

= 14 µmol/L

Limit of Quantitation

= 14 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 fructosamine samples.

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

Expected values

Expected values
LREFKruse-Jarres JD, Jarausch J, Lehmann P, et al. A new colorimetric method for the determination of fructosamine. Lab Med 1989;13:245-253.
,
LREFMelzi d’Eril GV, Bosini T, Solerte SB, et al. Performance and clinical significance of the new fructosamine assay in diabetic patients. Wien Klin Wochenschr Suppl 1990;180:60-63.

Fructosamine concentrations were determined in 555 apparently healthy subjects between the ages of 20 and 60. A reference range of 205 to 285 µmol/L was determined in this study for adults without diabetes. In a poorly controlled diabetic population, mean fructosamine values were reported to be 396 µmol/L (range 228‑563 µmol/L). A fructosamine concentration above the established expected value is an indicator for hyperglycemia during the preceeding 1‑3 weeks or longer.

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 fructosamine concentration of 285 µmol/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 5 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 85 µmol/L or 5 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 100 (approximate hemoglobin concentration: 62 µmol/L or 100 mg/dL).

Lipemia:

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 1800. 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: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.

As tested according to CLSI recommendation methyldopa causes artificially high fructosamine results.

LREFCLSI. Interference testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI document EP7-A2, Wayne, Pennsylvania, 2005.

Ascorbic acid: No significant interference from ascorbic acid up to a concentration of 170 µmol/L (30 mg/L).

In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:

Fructosaminecorr =

measured fructosamine × 72

measured total protein (in g/L)

Dysproteinemic states may affect fructosamine values.

LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

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

08105677 190

Fructosamine (550 tests)

System‑ID 2058 001

Roche/Hitachi cobas c 503

Materials required (but not provided):

11098993 122

Precimat Fructosamine (3 x 1 mL)

Code 20581

11098985 122

Precinorm Fructosamine (3 x 1 mL)

Code 20321

11174118 122

Precipath Fructosamine (3 x 1 mL)

Code 20322

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

System information

FRA: ACN 20580

", "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)

700/546 nm

Reagent pipetting

Diluent (H2O)

R1

45 µL

21 µL

R3

9 µL

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4.5 µL

Decreased

2.3 µL

Increased

4.5 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: Precimat Fructosamine

Calibration mode

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 fructose polylysine standard.

", "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
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

270

1.81

0.7

Precipath Fructosamine

527

3.07

0.6

Human serum 1

45.5

1.64

3.6

Human serum 2

109

1.30

1.2

Human serum 3

299

1.73

0.6

Human serum 4

526

3.63

0.7

Human serum 5

937

4.53

0.5

Intermediate precision

Mean
µmol/L

SD
µmol/L

CV
%

Precinorm Fructosamine

269

3.10

1.1

Precipath Fructosamine

526

6.16

1.2

Human serum 1

45.5

1.67

3.7

Human serum 2

109

1.63

1.5

Human serum 3

302

2.25

0.7

Human serum 4

526

5.30

1.0

Human serum 5

937

8.55

0.9

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

Method comparison

Fructosamine 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) = 75

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 = 0.976x + 19.6 µmol/L

y = 0.972x + 19.8 µmol/L

τ = 0.920

r = 0.998

The sample concentrations were between 19.1 and 960 µmol/L.

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

Summary

Summary
LREFJohnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chim Acta 1983;127:87-95.
,
LREFArmbruster DA. Fructosamine: structure, analysis, and clinical usefulness. Clin Chem 1987;33(12):2153-2163.
,
LREFCefalu WT, Bell-Farrow AD, Petty M, et al. Clinical validation of a second-generation fructosamine assay. Clin Chem 1991;37:1252-1256.
,
LREFHenrichs HR, ed. European Fructosamine Workshop. Wien Klin Wochenschr Suppl 1990;180.

Fructosamine represents non‑enzymatic glycation attached to blood and tissue proteins. The formation of fructosamine is a two‑step reaction, which is dependent on the glucose concentration. As a first step a Schiff base is formed by the reversible coupling of glucose to protein which, in a second step, is transformed by non‑reversible Amadori rearrangement to the corresponding ketoamine. This ketoamine is designated as fructosamine. The formation of fructosamine increases with the level of blood glucose. Metabolization occurs within 1 to 3 weeks, corresponding to the turnover of most serum proteins. The concentration of fructosamine thus reflects the average of the continuously varying blood glucose concentrations during this period, serving as a blood glucose memory.

Fructosamine is therefore a rapid indicator of glycemia in the diagnosis and management of diabetes mellitus.

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

Reagents - working solutions

R1

Nitroblue tetrazolium: 1.2 mmol/L; uricase (microbial): ≥ 12 µkat/L; pH 7.5; non‑reactive buffer; stabilizer; surfactants

R3

Carbonate buffer: 1.5 mol/L; pH 10.4

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Danger

H315

Causes skin irritation.

H318

Causes serious eye damage.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P310

Immediately call a POISON CENTER /doctor.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "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: Collect serum using standard sampling tubes.
Plasma: Li‑heparin and K2‑EDTA 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.

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.

Stability:

3 days at 15‑25 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 weeks at 2‑8 °C

LREFTietz NW. Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders 1999;797.

2 months at (-15)‑(-25) °C

LREFKoskinen P, Irjala K. Stability of Serum Fructosamine during Storage. Clin Chem 1988;34(12):2545-2546.

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

FRA

Fructosamine

IVD For in vitro diagnostic use.
FRA

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

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

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