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Transcript
0195BH1013D-1.qxp_Layout 1 2/11/15 6:52 AM Page 1
Technical
Data Sheet
Intact PTH
For In Vitro Diagnostic Use
The MicroVue PTH EIA measures the amount of intact Parathyroid Hormone (PTH) in experimental samples.
PTH (Parathyroid hormone, Parathormone, Parathyrin) is biosynthesized in the parathyroid gland as a pre-proparathyroid
hormone, a larger molecular precursor consisting of 115 amino acids. Following sequential intracellular cleavage of a
25 amino acid sequence, pre-proparathyroid hormone is converted to an intermediate, a 90 amino acid polypeptide,
proparathyroid hormone. With additional proteolytic modification, proparathyroid hormone is then converted to
parathyroid hormone, an 84 amino acid polypeptide.
In healthy individuals, regulation of parathyroid hormone secretion normally occurs via a negative feedback action of
serum calcium on the parathyroid glands. Intact PTH is biologically active and clears very rapidly from the circulation
with a half-life of less than four minutes. Intact PTH assays are important for the differentiation of primary hyperparathyroidism from the other (nonparathyroid-mediated) forms of hypercalcemia, such as malignancy, sarcoidosis
and thyrotoxicosis. The measurement of parathyroid hormone is the most specific way of making the diagnosis of
primary hyperparathyroidism. In the presence of hypercalcemia, an elevated level of parathyroid hormone virtually
establishes the diagnosis. In over 90% of patients with primary hyperparathyroidism, the parathyroid hormone will be
elevated.
Format
ELISA
96-well microplate with reagents
sufficient to test 40 samples in
duplicate
Sample type: Serum, plasma or
other experimental samples
Controls included
Species Reactivity
Human
Specimen
Samples collected to avoid
hemolysis
Assay Steps
Dilute Wash Buffer; reconstitute
Standard and Controls
Pipette 25 µL of Standards,
Control and samples into assay
wells
Add 50 µL of Biotin Labeled
Antibody and 50 µL of Enzyme
Labeled Antibody to each well
Incubate 3 hours ± 30 minutes at
22°C to 28°C with shaking
Wash the assay wells five times
Pipette 150 µL Substrate Solution
Incubate 30 ± 5 minutes at 22°C
to 28°C with shaking
Add 100 µL of Stop Solution to
each assay well
Measure absorbance at 450 nm
and again at 405 nm
Assay Performance
Method: ELISA
Analyte: Intact PTH
Specimen Volume: 25 µL
Limit of Detection: 1.57 pg/mL
Assay Range: 0-700 pg/mL
Precision (inter-assay): 2.8%-3.6%
Precision (intra-assay): 3.7%-6.1%
Assay Time: Approx. 4 hours
Quidel | Specialty Products | Research to Rapids® | quidel.com | 800.874.1517 | 858.552.1100
SL0205 | 0195BH1013D-1 (02/15)
MicroVue Intact PTH EIA – Cat. #8044