Assay for fetal thyroid function

• US 5,670,380 A
• Filed: 07/08/1994
• Issued: 09/23/1997
• Est. Priority Date: 05/04/1994
• Status: Expired due to Fees

• Current Assignee: Sing-Yung Wu
• Original Assignee: Sing-Yung Wu
• Inventors: Wu, Sing-Yung
• Primary Examiner(s): Scheiner, Toni R.
• Application Number:
  US08/273,104
• Time in Patent Office: 1,173 Days
• Field of Search: 435/7.1, 436/500, 436/501
• US Class Current: 436/500
• CPC Class Codes: G01N 33/78 Thyroid gland hormones , e.g. T3, T4, TBH, TBG or their receptors

Abstract

Disclosed is an assay for fetal thyroid function involving determining the amount of fetal thyroid function indicator that is present in the maternal blood and maternal urine and then comparing the determined value to a known standard for the gestation age of the fetus. It is defined as below one standard deviation of the normal values. Also disclosed is a method of treating a fetus having hypothyroidism involving determining that the fetus is hypothyroid using the assay of the present invention and thereafter, administering supplemental thyroid hormone (T₄, 500 ug/wk) into the amniotic sac. Also disclosed is a method of identifying euthyroid state using the assay of the present invention in hypothyroid fetuses receiving T₄ therapy.

Claims

1. An assay for quantifying fetal thyroid function of a fetus in a pregnant woman, comprising the steps of:

(a) obtaining a sample of fluid from said pregnant woman, wherein said fetus has a gestational age;

(b) determining the amount of Fetal Thyroid Hormone Indicator (FTFI) present in the fluid, said FTFI having the following characteristics;

immunological cross-reactivity with L-T₂ sulfate (T₂ S), presence in cord blood at birth, crosses the placenta, presence in maternal blood in an increasing concentration with gestational age in a normal pregnancy, and has a different chromatographic peak than synthetic T₂ S in high pressure liquid chromatography; and

is also present in maternal urine; and

(c) comparing the amount of determined FTFI to a known normal amount of FTFI for the gestational age, wherein a determined amount lower than about 1 standard deviation (SD) of the normal FTFI amount for the gestation age indicates abnormally low thyroid function in said fetus.

2. The method of claim 1, wherein the fluid is maternal blood.

3. The method of claim 1, wherein the fluid is maternal urine.

4. The method of claim 1, wherein the determining step comprises an immunoassay for said FTFI.

5. The method of claim 4, wherein said immunoassay uses an anti-T₂ S antibody.