Siemens IMMULITE 2000 Manual Del Usario página 6

High-dose Hook Effect:
None up to 500,000 ng/mL
Precision: Samples were assayed in
duplicate over the course of 20 days,
two runs per day, for a total of 40 runs and
80 replicates. (See "Precision" table.)
Linearity: Samples were assayed under
various dilutions. (See "Linearity" table for
representative data.)
Recovery: Samples spiked 1 to 19 with
three thyroglobulin solutions (380, 840
and 1,680 ng/mL) were assayed. (See
"Recovery" table for representative data.)
Bilirubin: Presence of bilirubin in
concentrations up to 200 mg/L has no
effect on results, within the precision of the
assay.
Hemolysis: Presence of packed red blood
cells in concentrations up to 30 µL/mL has
no effect on results, within the precision of
the assay.
Lipemia: Presence of triglycerides in
concentrations up to 3,000 mg/dL has no
effect on results, within the precision of the
assay.
Specificity: The assay is specific for
thyroglobulin, with no detectable
crossreactivity to alpha-fetoprotein (AFP),
FSH, TSH, diiodothyronine (T2),
triiodothyronine (T3) and thyroxine (T4).
(See "Specificity" table.)
Method Comparison: The assay was
compared to a commercially available
indirect solid phase enzyme immunometric
assay for thyroglobulin (Kit A) on 150
samples from patients with Hashimoto's
disease, Graves disease, patients who
had undergone thyroidectomy, as well as
euthyroid individuals. The thyroglobulin
concentrations of these patients covered
the entire calibration range of the assay.
The data are tabulated in reference to the
respective assays' suggested cutoffs.
IMMULITE 2000 Thyroglobulin
55 ng/mL 55 ng/mL
Kit A
50 ng/mL 10 0
50 ng/mL
10 130
Agreement: 93.3%
95% Confidence Limits for Relative Sensitivity
and Specificity, respectively: 69.2% – 100% and
87.3% – 96.5%,
6
Clinical Performance: A clinical study at
a university medical center in the
midwestern United States included 56
thyroid disease patients (41 females and
15 males, with an age range from 20 to
72 years) who provided from 2 to 6 serial
specimens in the course of their
treatments that included partial, subtotal or
total thyroidectomy, and other medical
interventions. The results of this study
showed that IMMULITE 2000
Thyroglobulin measurements were
consistent with the thyroid disease
conditions of these patients.
References
1) Bodlaender P, et al. Sensitive
radioimmunological screening test for
anti-thyroglobulin autoantibodies. Clin Chem
1978;24:272-4. 2) Cody V. Thyroglobulin and
thyroid hormone synthesis. Endocr Res
1984;10:73-88. 3) Czernichow P, et al. Plasma
thyroglobulin measurements help determine the
type of thyroid defect in congenital
hypothyroidism. J Clin Endocrinol Metab
1983;56242-5. 4) Dammacco F, et al. Serum
thyroglobulin and thyroid ultrasound studies in
infants with congenital hypothyroidism. J Pediat
1985;106:451-3. 5) Feldt-Rasmussen U. Serum
thyroglobulin and thyroglobulin autoantibodies in
thyroid diseases. Allergy 1983;38:369-87.
6) Gons MH, et al. Concentration of plasma
thyroglobulin and urinary excretion of iodinated
material in the diagnosis of thyroid disorders in
congenital hypothyroidism. Acta Endocrinol
1983;104:27-34. 7) Ket JL, et al. Serum
thyroglobulin levels: physiological decrease in
infancy and the absence in athyroidism. J Clin
Endocrinol Metab 1981;58:1301-3. 8) Lo Gerfo
P, et al. Thyroglobulin in benign and malignant
thyroid disease. JAMA 1979;241:923-5.
9) Pacini F, et al. Serum thyroglobulin in thyroid
carcinoma and other thyroid disorders.
J Endocrinol Invest 1980;3:283-92. 10) Pinchera
A, et al. Recent studies on the application of
serum thyroglobulin measurement in thyroid
disease. In: Eggo M, Burrow GN, editors.
Thyroglobulin – the prothyroid hormone. New
York: Raven Press, 1985: 307-16. 11) Refetoff
S, Lever EG. The value of serum thyroglobulin
measurement in clinical practice. JAMA
1983;250:2352-57. 12) Van Herle AJ, Vassart G,
Relative Relative
Dumont JE. Control of thyroglobulin synthesis
Sensitivity Specificity
and secretion. N Engl J Med 1979;301:239-49
and 307-14. 13) Walfish PG. Thyroid function in
100% 92.9% pediatrics. In: Hicks J, Boeckx RL, editors.
Pediatric clinical chemistry, Philadelphia: W.B.
Saunders, 1984: 170-239. 14) Spencer CA,
Wang C-C. Thyroglobulin measurement:
techniques, clinical benefits, and pitfalls.
Endocrinol Metab Clin North Am 1995;24:
841-63. 15) Spencer CA, Takeuchi M,
Kazarosyan M. Current status and performance
IMMULITE 2000 Thyroglobulin (PIL2KTY-22, 2015-04-22)