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Thyroid Peroxidase Antibody ELISA Kit (TPO-Ab)

INTENDED USE

Human thyroid peroxidase antibody ELISA kit is a reliable quantitative procedure for measuring human TPO-Ab (thyroid peroxidase antibody, TPO antibody) in human serum and plasma. This assay has a detection sensitivity limit of 5 IU/ml.

BACKGROUND

Thyroid peroxidase (TPO) is a membrane-bound hemoprotein which has a molecular weight of approx. 100kDa. It is essential for thyroid-hormone synthesis because this microsomal antigen is an integral membrane protein of microsomes. Persisting inhibition of TPO-activity by specific autoantibodies is found to cause a decrease in the synthesis of thyroid hormones and this lead to hypothyroidism. Also, high autoantibodies titers to thyroid peroxidase are frequently discovered in patients that have myxedema (atrophic thyroiditis), Hashimoto’s disease (goitrous thyroiditis) and Graves’ disease.

They may be predictive in asymptomatic individuals who are diagnosed for hypothyroidism. Especially at the end of pregnancy, where the determination of thyroid peroxidase antibody can be a helpful diagnostic tool to diagnose the early onset of post-partum hypothyroidism.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

1. Divisible Microplate: Wells coated with purified anti thyroid peroxidase antibody.
2. Calibrator A-F: Concentration 0-3000 IU/ml.
3. Control Positive and Control Negative.
4. Sample Buffer.
5. Enzyme Conjugate: Consisting of anti-human IgG antibody conjugated to HRP labelled.
6. Substrate Solution: Tetramethylbenzidin (TMB).
7. Stop Solution: Contains acid.
8. Wash Buffer (50x Concentarted).
9. Instruction for Use.
10. Certificate of Analysis

SENSITIVITY

The minimum sensitivity detection limit of human thyroid peroxidase antibody (TPO-Ab, TPO antibody) using current  TPO-Ab ELISA kit was approximately 5 IU/ml. The dynamic range for this assay is between 33 – 3,000 IU/ml.

ASSAY CHARACTERISTICS

– Measuring Range: 0 – 3000 IU/ml
– Expected Values: Cut-off 75 IU/ml
– Linearity: 98 – 109%
– Limit of Detection (LoD): 5 IU/ml
– Intra-Assay Precision: 1.5 – 2.9%
– Inter-Assay Precision: 3.1 – 9.7%
– Interfering Substances: None
– Clinical Diagnostics: Sensitivity (97.7%), Specificity (98.7%), Overall Agreement (98.2%)

REFERENCES

  1. Anti thyroid peroxidase antibody in patients with autoimmune thyroid disease: possible identity with antimicrosomal antibody. J Clin Endocrinol Metab 61 (1985) 1001-1003. Portmann, L., et al.
  2. Thyroid peroxidase is the organ-specific “microsomal” antigen involved in thyroid autoimmunity. Acta Endocrinol (Copenhagen) 281 (1987) 49-55. Ruf, J., et al.
  3. Thyroperoxidase, an auto-antigen with a mosaic structure made of nuclear and mitochondrial gene modules. EMBO J 6 (1987) 4193-4196. Libert, F., et al.
  4. Antithyroid peroxidase autoantibodies in thyroid disease. J Clin Endocrinol Metab 71 (1990) 661-669. Mariotti, S., et al.
  5. Autoimmune thyroid disease. Autoimmunity 37-4 (2004) 337-340. Weetman, A. P.

ADDITIONAL INFORMATION

  • Full Name: Thyroid Peroxidase Antibody ELISA Kit (TPO-Ab)
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity:  5 IU/ml

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