TPO IgG EULISA - Discontinued

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High titers of autoantibodies to thyroid peroxidase (TPO), a hemoprotein located in the microsomal membrane and involved in the synthesis of thyroid hormones, are frequently found in patients with goitrous thyroiditis (Hashimoto's disease), atrophic thyroiditis (myxedema) and Graves' disease (immunogenic form of hyperthyroidism). 
 
In most cases, TPO antibodies are found together with thyroglobulin (Tg) antibodies. Tg antibodies are considered as better markers of thyroiditis induction while TPO antibodies more specifically indicate active thyroid inflammation.

Product code
212096
Format
ELISA
Tests
Break apart micro titration strips (12x8) 96 wells
Calculation
Qualitative and quantitative
Antigen
Thyroid peroxidase (TPO)
Units
IU/mL
Calibrators
6
Range
0-3 000 IU/mL serum
Incubation time
30+30+30 min
Detection system
HRP/450 nm
Availability
CE marked. Not for sale in US

Intended use

Enzyme immunoassay for the detection of autoantibodies IgG against TPO.

Background

Autoimmune-mediated, pathogenically related disorders of the thyroid gland are characterized by the occurrence of autoantibodies directed at thyroid antigens, such as thyroglobulin (TG), thyroid peroxidase (TPO) and TSH receptor.

TPO (formerly known as thyroid microsomal antigen) is a thyrocyte-specific, glycosylated 105 kDa hemoprotein, located in the microsome membrane and involved in the synthesis of thyroid hormones. It constitutes a major antigen of the thyroid gland.

High titers of autoantibodies to TPO are frequently found in patients with goitrous thyroiditis (Hashimoto's disease), atrophic thyroiditis (myxedema) and Graves' disease (immunogenic form of hyperthyroidism). However, the antibody concentration does not usually reflect the degree of thyroid dysfunction or therapy effectivity. TPO inhibition caused by autoantibodies is believed to decrease the synthesis of thyroid hormones, thereby leading to hypothyroidism.

In most cases, TPO antibodies are found together with TG antibodies. TG antibodies are considered as better marker of thyroiditis induction while TPO antibodies more specifically indicate active thyroid inflammation. At a low percentage, TPO antibodies also occur in the normal population with a clear female predominance, their prevalence increasing with age.

Technical information

The EULISA TPO IgG is intended for the quantitative or qualitative determination of IgG antibodies in human serum, directed against TPO. The immobilised antigen is a highly purified preparation of recombinant human TPO. The test is fast (incubation time 30-30-30 minutes) and flexible (break apart wells, ready-to-use reagents). Six calibrators allow quantitative measurements; a negative and a positive control are used to check assay performance.

Kit components and storage of reagents

Contents of the kit

  1. 1 microwell plate, coated with TPO and hermetically packed in a foil laminate pouch together with a desiccant bag.
  1. Sample buffer, 100 mL, ready-to-use, orange coloured.
  1. Wash buffer, 100 mL, 10 x-concentrate, blue coloured.
  1. 6 calibrators, 2.0 mL each, 0, 30, 100, 300, 1 000 and 3 000 IU (IgG)/mL ready-to-use, gradually blue coloured.
  1. Negative and positive control, 2.0 mL each, ready-to-use, green and red coloured, respectively.
  1. Anti-human IgG HRP conjugate, 14 mL, ready-to-use, red coloured.
  1. Substrate solution, 14 mL, ready-to-use, colourless.
  1. Stop solution (0.5 M H2SO4), 14 mL, colourless, ready-to-use.
  1. Directions for use
  1. Lot-specific certificate of analysis

All kit components are stored at 2 - 8°C.