Abstract :
[en] Background: We carried out a technical evaluation of the
Immunodiagnostic Systems (IDS) automated intact procollagen-
I N-terminus propeptide (PINP) assay on the iSYS
platform, and established reference intervals for PINP in
both adults and children.
Methods: Assay imprecision, recovery and interference
were studied. Serum and plasma values were compared,
and PINP stability was assessed. Using 828 specimens,
IDS iSYS intact PINP and Roche E170 total PINP values
were compared. Specimens from 597 adults and 485 children
and adolescents were used to establish reference
intervals for intact PINP.
Results: The method demonstrated good recovery and
acceptable imprecision. The assay was unaffected by
icterus and lipaemia, but haemolysis decreased measured
PINP. Serum and plasma values were comparable. There
was a non-linear relation between IDS intact and Roche
total PINP values. Pre- and post-menopausal women
had comparable PINP values, but there was a difference
between women of different age groups. Serum PINP in
men showed a decline in young age up to 45 years, but
remained steady thereafter. Separate reference intervals
were established for four age groups in women and for
two age groups in men. Data for children were partitioned
into four-year age groups, and these showed PINP to be
high with no major gender differences until 12 years of
age. Thereafter, values in females decreased in 13–16 years
age groups and further in 17–20 years age groups, whereas
PINP increased in boys of 13–16 years of age with a subsequent
decline at 17–20 years.
Conclusions: The IDS iSYS PINP intact assay appears to
be reliable. We have established gender- and age-related
reference intervals for children and adults based on a relatively
large healthy North European population.
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