In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test by reaction with nitroblue tetrazolium.
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.
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.
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.
Criterion: Recovery within ± 10 % of initial value at a fructosamine concentration of 285 µmol/L.
Icterus:
Hemolysis:
Lipemia:
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Exception: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.
As tested according CLSI recommendation Methyldopa causes artificially high fructosamine results.
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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
Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
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 |
FRA: ACN 8667
Ready for use
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 | – | – |
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 |
Calibrators | S1: H2O S2: Precimat Fructosamine |
Calibration mode | Linear |
Calibration frequency | 2‑point calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against fructose polylysine standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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.
Fructosamine values for human serum and plasma samples obtained on a
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. |
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.
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.
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:
![](\"http://pim-media.roche.com/Images/GHS_acid_922236427_All.jpg\"/)
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 | 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
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.
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.
In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on COBAS INTEGRA systems.
Colorimetric test by reaction with nitroblue tetrazolium.
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.
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).
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.
In hydremic states (pregnancy for instance) it may be favorable to relate fructosamine to protein using the following formula:
Fructosamine corr = | measured fructosamine × 72 |
Dysproteinemic states may affect fructosamine values.
Criterion: Recovery within ± 10 % of initial value.
Serum/plasma
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.
|
| 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 |
Test FRA, test ID 0‑056.
Ready for use
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).
Diluent (H2O) | ||
R1 | 60 µL | 24 µL |
Sample | 6 µL | 12 µL |
SR | 12 µL | 12 µL |
Total volume | 126 µL |
Shelf life at 2‑8 °C | See expiration date on cobas c pack label |
On-board in use at 10‑15 °C | 8 weeks |
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.
Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.
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 % |
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 | 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.
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.
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.
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
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.
For specimen collection and preparation only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable:
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.
In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on
Colorimetric test by reaction with nitroblue tetrazolium.
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.
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).
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.
Criterion: Recovery within ± 10 % of initial value at a fructosamine concentration of 285 µmol/L.
Icterus:
Hemolysis:
Lipemia:
Drugs: No interference was found at therapeutic concentrations using common drug panels.
Exception: Levodopa causes artificially high fructosamine results. Oxytetracycline causes artificially high fructosamine results.
As tested according CLSI recommendation Methyldopa causes artificially high fructosamine results.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
04537939190 | Fructosamine (150 tests) | System‑ID 07 3756 9 |
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 |
For cobas c 311/501 analyzers:
FRA: ACN 667
For cobas c 502 analyzer:
FRA: ACN 8667
Ready for use
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 | – | – |
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 |
Calibrators | S1: H2O S2: Precimat Fructosamine |
Calibration mode | Linear |
Calibration frequency | 2‑point calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against fructose polylysine standard.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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).
Fructosamine values for human serum and plasma samples obtained on a
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).
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.
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.
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 | 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
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.
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. |
In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test by reaction with nitroblue tetrazolium.
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.
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.
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.
Criterion: Recovery within ± 10 % of initial value at a fructosamine concentration of 285 µmol/L.
Icterus:
Hemolysis:
Lipemia:
Drugs: No interference was found at therapeutic concentrations using common drug panels.
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.
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
FRA: ACN 20580
Ready for use
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.
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 |
Calibrators | S1: H2O S2: Precimat Fructosamine |
Calibration mode | Linear |
Calibration frequency | Automatic full calibration Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against fructose polylysine standard.
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.
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 | SD | 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 | SD | 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 |
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. |
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.
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.
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 | 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
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.
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. |
In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on
Colorimetric test by reaction with nitroblue tetrazolium.
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.
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.
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.
Criterion: Recovery within ± 10 % of initial value at a fructosamine concentration of 285 µmol/L.
Icterus:
Hemolysis:
Lipemia:
Drugs: No interference was found at therapeutic concentrations using common drug panels.
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.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
FRA: ACN 20580
Ready for use
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.
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 |
Calibrators | S1: H2O S2: Precimat Fructosamine |
Calibration mode | Linear |
Calibration frequency | Automatic full calibration Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against fructose polylysine standard.
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.
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 | SD | 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 | SD | 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).
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. |
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.
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.
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 | 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
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.
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. |
In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on
Colorimetric test by reaction with nitroblue tetrazolium.
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.
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.
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.
Criterion: Recovery within ± 10 % of initial value at a fructosamine concentration of 285 µmol/L.
Icterus:
Hemolysis:
Lipemia:
Drugs: No interference was found at therapeutic concentrations using common drug panels.
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.
Ascorbic acid: No significant interference from ascorbic acid up to a concentration of
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
FRA: ACN 20580
Ready for use
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.
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 |
Calibrators | S1: H2O S2: Precimat Fructosamine |
Calibration mode | Linear |
Calibration frequency | Automatic full calibration Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against fructose polylysine standard.
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.
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 | SD | 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 | SD | 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).
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. |
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.
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.
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 | 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
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.
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. |
In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.
Colorimetric test by reaction with nitroblue tetrazolium.
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.
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.
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.
Criterion: Recovery within ± 10 % of initial value at a fructosamine concentration of 285 µmol/L.
Icterus:
Hemolysis:
Lipemia:
Drugs: No interference was found at therapeutic concentrations using common drug panels.
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.
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
FRA: ACN 20580
Ready for use
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.
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 |
Calibrators | S1: H2O S2: Precimat Fructosamine |
Calibration mode | Linear |
Calibration frequency | Automatic full calibration Full calibration |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Traceability: This method has been standardized against fructose polylysine standard.
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.
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 | SD | 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 | SD | 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 |
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. |
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.
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.
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
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.
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. |
Fructosamine
![](\"http://pim-media.roche.com/Images/REF_Frame_1_970150539_All.jpg\"/)
![](\"http://pim-media.roche.com/Images/CONTENT_Frame_1_970070027_All.jpg\"/)
