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Disease/health condition -
Endocrine disorders
Luteinizing hormone (LH)
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
54253
Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) 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
W0102050105
LUTEINISING HORMONE
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 Luteinizing Hormone (LH) 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 LH test category be asked to provide information on the applications of LH 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 LH test category be asked to provide information on the applications of LH 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. And testing LH levels is part of several international guidelines and best practice for a large number of indications in fertility medicine, gonadal disorders, anovulation, amenorrhoea and menstrual irregularities. 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. And there is little evidence available to review for the clinical impact of LH testing. SAGE IVD emphasized that LH testing goes hand in hand with FSH testing; and that result interpretation requires appropriate laboratory infrastructure and the availability of fertility or endocrinology specialists. The group also highlighted the importance of timing in sample collection (although timing requirements may vary depending on the condition being monitored).
SAGE IVD noted that the specimen types listed in the LH submission to the EDL did not include urine, even though urine LH is often used in practice, appears in at least one international guideline and is the subject of a published Cochrane review.
The group further noted that while LH testing is critical to evaluate and manage infertility, additional investigations may be needed for a definitive diagnosis.
The LH test is proposed to aid in the diagnoses of various diseases, including disorders of sexual development (DSD) and polycystic ovary syndrome (PCOS), to evaluate the causes of infertility, amenorrhoea and/or irregular menstrual bleeding and suspected Leydig cell insufficiency. Although guidelines and expert opinions state that LH tests are necessary to diagnose these conditions, there is very limited evidence on their diagnostic accuracy and no evidence on their clinical utility on their own.
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