Performance Data - Siemens Coat-A-Count TSH IRMA Manual Del Usuario

Further Reading: See Dudley RA, et al.
Guidelines for immunoassay data
reduction. Clin Chem 1985;31:1264-71.
Example Run: For illustration only. Not for
calculating results from another run. (See
"Example Run" table.)
Expected Values
Serum samples from a total of 443 adults
with no known thyroid dysfunction were
assayed by the Coat-A-Count TSH IRMA
procedure. The results showed a nearly
log-normal distribution, with a median of
1.3 µIU/mL, and suggest a reference
range of
0.3 – 5 µIU/mL
for adults with no known thyroid
dysfunction.
Laboratories should consider these results
as guidelines only. Each laboratory should
establish its own reference ranges.
Serum samples from patients with
untreated hyperthyroidism and untreated
primary hypothyroidism were also assayed
by the Coat-A-Count TSH IRMA
procedure, with the following results, in
µIU/mL.
Absolute
Reference Group
Hyperthyroid
Hypothyroid 5.7 – 150
ND: not detectable
The table shows that the Coat-A-Count
TSH IRMA procedure achieves a good
separation between patients with frank,
untreated hyperthyroidism or
hypothyroidism, on the one hand, and
individuals with no known thyroid
dysfunction. It should be remembered,
however, that hyperthyroidism and
hypothyroidism are graded conditions; this
implies that not all patients in these
disease categories can be expected to
have TSH levels as extreme as those
indicated in the table above. Conversely,
especially in hospital settings, patients
with no known thyroid dysfunction may
exhibit TSH levels outside the reference
range as a consequence of nonthyroidal
illness or treatment with glucocorticoids,
dopamine or other drugs.
Coat-A-Count TSH IRMA (PIIKTS-8, 2010-11-04)
Range Median
<0.15
ND
49
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Performance Data

See Tables and Graphs for data
representative of the Coat-A-Coat TSH
IRMA kit's performance. TSH results in the
sections below are expressed as µIU/mL.
Calibration Range: 0.15 – 60 µIU/mL
n
Analytical Sensitivity: 0.03 µIU/mL
61
Intraassay Precision (Within-Run):
77
Statistics were calculated for each of
seven samples from the results of 20 pairs
of tubes in a single assay. (See
"Intraassay Precision" table.)
Interassay Precision (Run-to-Run):
Statistics were calculated for each of
seven samples from the results of pairs of
tubes in 20 different assays. (See
"Interassay Precision" table.)
End-of-Run Effect: None up to
approximately 350 tubes (See "End-of-
Run Effect" table.)
Specificity: The Coat-A-Count TSH IRMA
antibodies are highly specific for TSH, with
an extremely low crossreactivity to other
glycoprotein hormones such as FSH, LH
and HCG.
Three patient samples containing elevated
levels of TSH were spiked with different
amounts of FSH, LH or HCG. The
samples were then assayed both spiked
and unspiked by the Coat-A-Count TSH
7