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STORE AT 2-8ºC
Reagents for measurement of fructosamine concentration FRUCTOSAMINE
Only for in vitro use in the clinical laboratory NBT
− Reagent: Presence of particulate material, turbidity, absorbance over 0.065 at 530 nm (1 cm DIAGNOSTIC CHARACTERISTICS
cuvette). Fructosamine is the generic name for plasma protein ketoamines formed by non-enzymatic
− Standard: Absence of lyophilised material. Presence of moisture. attachment of glucose to amino groups of proteins (largely albumin).
REAGENT PREPARATION The measurement of fructosamine is useful to monitor the average concentration of blood
glucose for an extended period of time (2-3 weeks) in individuals with diabetes mellitus.
Reagent (A) is provided ready to use. Because fructosamine determination monitors short-term glycemic changes different from
Standard (S): Reconstitute with 1.00 mL of distilled water. Mix gently and let stand for 30 glycated hemoglobin, it is recommended to be used in conjuction with glycated hemoglobin
minutes before using. The solution is stable for 15 days at 2-8ºC if contaminations are prevented rather than instead of it2.
during their use, or for 45 days at -20ºC when frozen in aliquots. Glycated protein levels are a valuable adjunt to blood glucose determinations in the assessment
of glycemic control. However, these proteins are not reliable for the diagnosis of diabetes
ADDITIONAL EQUIPMENT mellitus2,6.
− Analyzer, spectrophotometer or photometer with cell holder thermostatable at 37ºC and able Clinical diagnosis should not be made on the findings of a single test result, but should integrate
to read at 530 ± 20 nm. both clinical and laboratory data.
SAMPLES NOTES
Serum collected by standard procedures. Hemolysed samples are not suitable for testing. 1. The reagent may be used in several automated analyzers. Instructions for many of them are
Fructosamine in serum is stable for 7days at 2-8ºC. available on request.
PROCEDURE BIBLIOGRAPHY
1. Bring the Reagent to room temperature. 1. Baker R John, Metcalf A Patricia, Johnson N Roger, Newman David and Rietz Peter. Use of
protein-based standards in automated colorimetric determinations of fructosamine in serum.
2. Pipette into labelled test tubes: (Note 1)
Clin Chem 1985; 31: 1550-1554.
Sample Standard
2. Tietz Textbook of Clinical Chemistry, 2nd edition. Burtis CA, Ashwood ER. WB Saunders
Reagent (A) 1.0 mL 1.0 mL Co., 1994.
Sample 50 µL
3. Van Dieijen-Visser MP, Seynaeve C and Brombacher PJ. Influence of variations in albumin
Standard (S) 50 µL
or total-protein concentration on serum fructosamine concentration. Clin Chem 1986; 32:
3. Mix thoroughly and incubate immediately at 37ºC. Start the stopwatch. 1610.
4. Read the absorbance (A) of the Sample and Standard at 530 nm after exactly 10 minutes 4. Hurst L Paul. Effect of anticoagulants on fructosamine determination. Clin Chem 1987; 33:
(A1) and 15 minutes (A2) of incubation against distilled water. 1947.
5. Young DS. Effects of drugs on clinical laboratory tests, 3th ed. AACC Press, 1997.
CALCULATIONS 6. Friedman and Young. Effects of disease on clinical laboratory tests, 3th ed. AACC Press,
The fructosamine concentration in the sample is calculated using the following general formula: 1997.
(A2 - A1) Sample
× C Standard = C Sample
(A2 - A1) Standard
REFERENCE VALUES
Serum1,2: 1.9-2.9 mmol/L (DMF), 205-285 µmol/L (glycated albumin). Concentrations are
slightly lower (5%) in child. Fructosamine reference values depends on albumin concentration . 3
These ranges are given for orientation only; each laboratory should establish its own reference
ranges.
QUALITY CONTROL
Each laboratory should establish its own internal Quality Control scheme and procedures for
corrective action if controls do not recover within the acceptable tolerances.
METROLOGICAL CHARACTERISTICS
− Detection limit: 0.14 mmol/L (DMF), 16 µmol/L (glycated albumin).
− Linearity limit: 7 mmol/L (DMF), 800 µmol/L (glycated albumin). For higher values dilute
sample 1/2 with distilled water and repeat measurement.