Suhair Abdalrahman Ahmed

Quality assurance during the

pre-analytical activity
(Biological sources of variation).

Suhair.A.A./ Quality Assurance / 3rd year 2

Suhair.A.A./ Quality Assurance / 3rd year 3
Suhair.A.A./ Quality Assurance / 3rd year 4
When receiving the report the clinician may
ask?

Suhair.A.A./ Quality Assurance / 3rd year 5

Pre-examination Processes

Suhair.A.A./ Quality Assurance / 3rd year 6

⚫ The procedure for collection, handling,
and processing before analysis,
constitute the preanalytic phase.
⚫ Physiologic variables, such as age, and
sex, and conditions such as pregnancy
and menstruation, are some of the
preanalytic phase factors.

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Within-subject
biological variation
⚫ Fluctuation of the concentration
of body fluid components
around the setting point

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Between-subject
biological variation
⚫ Differences in concentration
of the components of
biologic fluids
among persons

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Physiologic Variables

⚫ Age
The effect of age on laboratory results has been
well recognized to the point that separate
reference intervals have been used to distinguish
pediatric, adolescent, adult, and geriatric
populations.
Neonates
Increased RBC count leading to increased glucose
metabolism
Growing child
3-fold increase in alkaline phosphatase level due
to bone growth

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Physiologic Variables

⚫ Sex Differences
The differences for some of the analytes based
on sex can be explained as due to differences in
muscle mass and to endocrine and organ-specific
differences.
E.g. Between 15 and 55 years, progressive
increase in total and LDL cholesterol levels;
higher in premenopausal females , owing to the
stimulating effect of estrogens. Creatinine and
CK are muscle mass dependent; generally higher
in males
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⚫ Time
There are time-related fluctuations in the
level of some analytes .Circadian rhythm
(Biorythum) is responsible for the diurnal
changes seen in the circulating levels of
some analytes. A classic example of an
analyte subject to diurnal variation is
cortisol, which generally peaks at around
9:00 AM, with levels becoming lower toward
the evening and midnight.
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⚫ Seasonal Changes
Vitamin D levels tend to be higher during the
summer , apparently due to prolonged
exposure to sunlight
A slight increase in the total cholesterol
level (average, 2.5%) has been observed
during the winter compared with values
measured during the summer.

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Physiologic Variables

⚫ Altitude
Changes in levels of some of the
constituents in blood occur when measured
at sea level as opposed to measurement at a
higher altitude. For example, hematocrit and
hemoglobin levels can be up to 8% higher at
an altitude.

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Physiologic Variables

⚫ Menstruation
Estradiol, FSH, LH, progesterone levels
depend on stages of cycle . Cholesterol level
lowest at ovulation . Decrease in serum iron
and phosphate.

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Physiologic Variables

⚫ Pregnancy
⚫ A dilutional effect is observed due to an
increase in the mean plasma volume, which in
turn causes hemodilution. The effect is more
pronounced when measuring trace
constituents such as trace elements in serum.
During pregnancy, there is a considerable
increase in the glomerular filtration rate.
Hence, the creatinine clearance rate is
increased by 50% or more over the normal
rate.
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 Lifestyle

⚫ Diet influences the results obtained for

some analytes . Differences between
vegetarians and nonvegetarians. consuming
a high-protein or a high-purine diet are
well known.
⚫ Nonvegetarians tend to have increased
blood levels of uric acid, urea, and ammonia
compared with those for their vegetarian
counterparts.
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