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Disease/health condition -
Endocrine disorders
Estradiol
Assay format
Immunoassay
Information History
First added in 2020
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of primary and secondary amenorrhoea, anovulation, gonadal dysfunction and precocious puberty. To aid in the evaluation and management of infertility.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
54152
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using an enzyme immunoassay (EIA) method.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024EMDN
W0102050103
ESTRADIOL
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
N/A
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including the estradiol test category in the third EDL:
• as a disease-specific IVD for use in clinical laboratories (EDL 3, Section II.b, within a new subsection for endocrine disorders);
• using an immunoassay format;
• to aid in the diagnosis of primary and secondary amenorrhoea, anovulation, gonadal dysfunction and precocious puberty; and
• to aid in the evaluation and management of infertility. The group requested the addition of a note to the test category entry in the EDL stating that it is only recommended for use in specialized health care settings. The group further requested that the original submitter of the estradiol test category be asked to provide information on the applications of estradiol in urine to support an edit of the EDL entry next year.
• as a disease-specific IVD for use in clinical laboratories (EDL 3, Section II.b, within a new subsection for endocrine disorders);
• using an immunoassay format;
• to aid in the diagnosis of primary and secondary amenorrhoea, anovulation, gonadal dysfunction and precocious puberty; and
• to aid in the evaluation and management of infertility. The group requested the addition of a note to the test category entry in the EDL stating that it is only recommended for use in specialized health care settings. The group further requested that the original submitter of the estradiol test category be asked to provide information on the applications of estradiol in urine to support an edit of the EDL entry next year.
The consequences of infertility from a personal and social point of view can be dramatic. Fertility is considered a major public health issue by WHO. Estradiol is used in clinical practice as part of a battery of tests for diagnosing and managing a range of fertility issues. It forms part of several international guidelines for diagnosing WHO I–III anovulation. It is also acknowledged in guidelines to be of some (more limited) use in diagnosing and monitoring ovarian reserve, amenorrhoea, PP and hypogonadism. One of the medicines that is routinely used in fertility – clomiphene – is also included in the complementary list of the EML.
There is, however, potential for overuse of the test. SAGE IVD emphasized that result interpretation requires appropriate laboratory infrastructure and the availability of fertility or endocrinology specialists. The group also emphasized that estradiol test results can only be interpreted correctly in combination with other tests, for example FSH.
SAGE IVD noted that the specimen types listed in the estradiol submission to the EDL did not include urine, even though urine testing is often used in practice.
The estradiol test is aimed at aiding the diagnosis of disorders related to reproductive dysfunction in women, more specifically to screen for decreased ovarian reserve. No evidence is presented on the diagnostic accuracy of the test for these conditions. Practice guidelines and committee opinions recommend using estradiol for a range of conditions including WHO I–III anovulation, amenorrhoea, menstrual irregularities and hypogonadism, although they warn against using basal estradiol alone to screen for decreased ovarian reserve.
The estradiol test has value as an aid to correct interpretation of a ‘‘normal’’ basal serum FSH value.
World Health Organization. (2021). The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (including the third WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/339064