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The development of a new reference range for fructosamine for the pathcare pathology group, Somerset West, South Africa
Author(s)
Smit, Francois Christiaan
Date Issued
2010
Type
Thesis
Publisher
Cape Peninsula University of Technology
Abstract
Fructosamine is a generic name given to a compound known as plasma protein
ketoamines. It is formed by a non-irreversible enzymatic reaction between glucose and
serum proteins, mainly albumin. Fructosamine together with glycated haemoglobin
(HbA1c) are used to monitor the state of hyperglycaemia in diabetics. It provides the
clinician with an index of glycaemia over a shorter period of time than HbA1c, about 4
weeks due to the high turnover of human serum albumin in blood and the degree of
glycation in serum proteins. The evolvement of automation in Clinical Chemistry
necessitates that each pathology laboratory provides relevant sets of reliable reference
values that are population and analyzer or method specific. Currently, the reference
range for fructosamine at PathCare ranges between 200 to 285 μmol/L.
Four hundred and forty six (120 white females, 117 white males, 114 mixed ancestry
females, 95 mixed ancestry males) apparently healthy participants visiting the PathCare,
Somerset West practice, were recruited for this study. Fructosamine, random blood
glucose, HbA1c, total protein, albumin, and lipid profile was preformed on all individuals.
Nonparametric methods, whereby the sample 2.5 and 97.5 percentiles are used to form
the 95% reference interval, were used to determine the reference values for
fructosamine.
Though no significant differences (p = 0.086) were observed between males and
females in the total population group the mixed ancestry males had significantly higher
fructosamine levels (p = 0.01) compared to their female counterparts. The reference
range of the entire sample was 223 – 295 μmol/L, however differed in the different
population groups (white females = 228 - 291 μmol/L, white males= 223 – 296 μmol/L,
mixed ancestry females = 217 - 293 μmol/L and mixed ancestry males = 222 – 304
μmol/L).
The new fructosamine reference range obtained in this study showed a significant
difference than the one used at Pathcare, which is 200 – 285 μmol/L. Our results further
strengthen the recommendations by pathology bodies that laboratories must establish
reference values that are representative of local populations. The single reference range
(226 - 293 μmol/L) for the Caucasian males and females is recommended, however due
to the significant differences observed between the mixed ancestry males and females it
is recommended that gender specific references ranges be used for this population
group, which are: 1) 222 - 304 μmol/L for the mixed ancestry males and 2) 217 - 293
μmol/L for the mixed ancestry females respectively.
ketoamines. It is formed by a non-irreversible enzymatic reaction between glucose and
serum proteins, mainly albumin. Fructosamine together with glycated haemoglobin
(HbA1c) are used to monitor the state of hyperglycaemia in diabetics. It provides the
clinician with an index of glycaemia over a shorter period of time than HbA1c, about 4
weeks due to the high turnover of human serum albumin in blood and the degree of
glycation in serum proteins. The evolvement of automation in Clinical Chemistry
necessitates that each pathology laboratory provides relevant sets of reliable reference
values that are population and analyzer or method specific. Currently, the reference
range for fructosamine at PathCare ranges between 200 to 285 μmol/L.
Four hundred and forty six (120 white females, 117 white males, 114 mixed ancestry
females, 95 mixed ancestry males) apparently healthy participants visiting the PathCare,
Somerset West practice, were recruited for this study. Fructosamine, random blood
glucose, HbA1c, total protein, albumin, and lipid profile was preformed on all individuals.
Nonparametric methods, whereby the sample 2.5 and 97.5 percentiles are used to form
the 95% reference interval, were used to determine the reference values for
fructosamine.
Though no significant differences (p = 0.086) were observed between males and
females in the total population group the mixed ancestry males had significantly higher
fructosamine levels (p = 0.01) compared to their female counterparts. The reference
range of the entire sample was 223 – 295 μmol/L, however differed in the different
population groups (white females = 228 - 291 μmol/L, white males= 223 – 296 μmol/L,
mixed ancestry females = 217 - 293 μmol/L and mixed ancestry males = 222 – 304
μmol/L).
The new fructosamine reference range obtained in this study showed a significant
difference than the one used at Pathcare, which is 200 – 285 μmol/L. Our results further
strengthen the recommendations by pathology bodies that laboratories must establish
reference values that are representative of local populations. The single reference range
(226 - 293 μmol/L) for the Caucasian males and females is recommended, however due
to the significant differences observed between the mixed ancestry males and females it
is recommended that gender specific references ranges be used for this population
group, which are: 1) 222 - 304 μmol/L for the mixed ancestry males and 2) 217 - 293
μmol/L for the mixed ancestry females respectively.
Additional information
Thesis (MTech (Biomedical Technology))--Cape Peninsula University of Technology, 2010
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