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Printed For Final Review: 10/10/03
ECO Number: 27341
MID-MOLECULE PARATHYROID HORMONE RADIOIMMUNOASSAY
1.
INTENDED USE
FOR IN VITRO DIAGNOSTIC USE.
This kit contains instructions and material for the quantitative determination of parathy-
roid hormone containing mid-molecule and C-Terminal sequences in serum or plasma
by radioimmunoassay.
2.
SUMMARY AND EXPLANATION
Native parathyroid hormone is an 84 amino acid peptide which acts to increase serum
calcium by specific effects in soft tissue and bone metabolism. Parathyroid peptides
are secreted from small glands in response to a decrease of serum calcium. High
levels of serum calcium generally inhibit PTH secretion, except in the case of PTH-
secreting tumors. PTH circulates at a relatively low concentration; therefore, sensitive
radiometric techniques are needed to measure PTH in blood.
Clinically, the measurement of PTH has proven to be an extremely helpful and efficient
tool in the differential diagnosis and management of hypercalcemia; more specifically,
PTH measurement can help the physician diagnose tumors and hyperplasia of the
para-thyroid glands.
PTH can also be useful in localizing hyperfunctioning parathyroid
1
tissue by RIA of samples obtained via venous catheterization.
radio-immunoassay is also useful for the diagnosis and management of hypocalcemia
since,
with
rare
exceptions,
(hypoparathyroidism) have subnormal concentrations of PTH.
Evidence from several sources,
parathyroid peptides containing the mid-molecule region of human PTH may be the
most important markers for primary hyperparathyroid disease.
3.
PRINCIPLE OF THE ASSAY
The DiaSorin PTH-MM II RIA is a disequilibrium procedure using delayed tracer
addition to increase sensitivity. Antiserum is directed to only the mid-region of human
parathyroid hormone. Iodination is done by conventional methods utilizing synthetic
hPTH [Tyr 43] 44-68. In this RIA, sample and PTH-MM antiserum are combined and
incubated for 15 minutes at room temperature. Tracer is then added, followed by a
second incubation for 2 hours at 4°C. Phase separation is done in 15 minutes with a
pre-precip-itated complex of second antibody, carrier, and PEG added in a single
pipetting step. Calibrators are expressed as picomoles/liter of mid-molecule fragment.
4.
REAGENTS PROVIDED IN THE KIT
PTH-MM Primary Antibody
PTH-MM Calibrators (0-6)
PTH-MM DAG-ppt
PTH-MM Tracer (Red)
PTH-MM Controls
Number of tests
STORAGE: Upon receipt, the kit should be stored at 2-8°C, except the Precipitating
Complex which should be stored at –15°C. After opening, store each reagent at 2-8°
until the expiration date on the label. Reagents should not be used past the expiration
date. Reagents from different batches must not be mixed.
10:45 AM
hypocalcemic
persons
3-5
including DiaSorin Inc.,
6
7
1 vial/14 mL
1 vial/10 mL,
6 vials/1.0 mL
1 vial/35 mL
1 vial/14 mL
2 vials/1.0 mL
65
1
Finally, the PTH-MM
II
1
TM
with
deficient
PTH
now suggests that the
2 vials/14 mL
1 vial/10 mL,
6 vials/1.0 mL
2 vials/35 mL
2 vials/14 mL
2 vials/1.0 mL
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