Anti-Thyroid Peroxidase (Anti-TPO) ELISA

Enzyme immunoassay for the quantitative measurement of Anti-Thyroid Peroxidase (Anti-TPO) autoantibodies in human serum.

INTENDED USE:For the quantitative measurement of Anti-Thyroid Peroxidase (Anti-TPO) autoantibodies in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). Results shall be used in combination with other clinical and laboratory data to aid in the diagnosis of autoimmune thyroid diseases in the general population. This kit is intended for professional use only and is for laboratory use only. For in vitro diagnostic use only. Intended to be used manually but may be adaptable to open automated analyzers. The user is responsible for validating the performance of this kit with any automated analyzers.

GENERAL INFORMATION:Thyroid peroxidase (TPO), a glycoprotein with a molecular weight of 100 kD, is identified as the primary antigenic component of microsomes in thyroid cells. TPO catalyses the iodination of tyrosine in thyroglobulin during the biosynthesis of triiodothyronine and thyroxine (T3 and T4, respectively). Disorders of the thyroid gland are frequently caused by autoimmune reactions. TPO and thyroglobulin are the most important targets for autoimmune attacks. The major thyroid autoimmune diseases are Hashimoto’s thyroiditis and Graves’ disease. Anti-TPO autoantibodies are detected in 90–95% of autoimmune thyroid disease (AITD) patients, 80% of Graves’ disease (GD), and 10–15% of non-AITD patients. A high level of anti-TPO helps to confirm the diagnosis of these thyroid autoimmune disorders. The prevalence of TPO antibodies is higher in elderly (mean age 80 years) women (10%) compared to elderly men (2%).

KIT CHARACTERISTICS:
- Method: ELISA
- Tests: 96
- Incubation Time / Conditions: 30 min (RT), 30 min (RT), 15-20 min (RT/dark)
- Standard Range: 10 - 1,000 IU/ml
- Sensitivity analytical: LoD: 0.819 IU/ml
- Final Sample Volume: 100 µl
- Sample Type: serum
- Sample Pretreatment: dilution 1:20
- Isotope / Substrate: TMB 450 nm
- Internal Controls: 2
- Regulatory Status: CE