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Disease/health condition -
Endocrine disorders
17-Hydroxyprogesterone (17-OHP)
Assay format
Immunoassay
Information History
First added in 2022
Purpose type
Diagnosis, Montoring
Purpose
To diagnose and monitor congenital adrenal hyperplasia (CAH) outside of the neonatal period.* .
* Not appropriate for screening
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
63577
17-Hydroxyprogesterone 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 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of congenital adrenal hyperplasia (CAH).
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
W0102050107
17 OH Progesterone
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 listing the 17-hydroxyprogesterone (17-OHP) test category in EDL 4
• as a disease-specific IVD for use in clinical laboratories (EDL 4, Section II.b);
• using an immunoassay format;
• using serum and plasma as specimen types;
• to diagnose and monitor congenital adrenal hyperplasia (CAH) outside of the neonatal period. SAGE IVD also recommended including a note to the EDL table stating that the test is not appropriate for screening.
• as a disease-specific IVD for use in clinical laboratories (EDL 4, Section II.b);
• using an immunoassay format;
• using serum and plasma as specimen types;
• to diagnose and monitor congenital adrenal hyperplasia (CAH) outside of the neonatal period. SAGE IVD also recommended including a note to the EDL table stating that the test is not appropriate for screening.
The 17-OHP assay is intended to diagnose congenital adrenal hyperplasia (CAH).
SAGE IVD members noted that the evidence for the use of the test in different settings was not well defined in this application. For example, 17-OHP is appropriate for diagnosing CAH outside of the neonatal period as well as other adrenal and ovarian issues in older persons. Moreover, some experts questioned whether the test was intended for screening or for diagnosis.
One expert explained that this test is used to support the diagnosis of CAH outside of the neonatal period, to monitor CAH therapy, and to assess and manage hirsutism and infertility.
The group noted that WHO and the United Nations Children’s Fund have referred to the unreliability of the test for screening for a range of pregnancy conditions. One member highlighted that using 17-OHP to screen in a neonatal setup generates 1–2% false positives in the best case, making it unfeasible. And for neonatal screening, spectroscopy or high-performance chromatography are the preferred modalities in any event.
SAGE IVD acknowledged the limited evidence for the test within this application. However, the group saw value in this test.
The experts acknowledged that using 17-OHP to diagnose CAH is appropriate and important for patients. Consequently, SAGE IVD decided to list the 17-OHP assay specifically to diagnose CAH outside of the neonatal period, but not to screen for it.
CAH is a rare health problem, but it can be life-threatening if not diagnosed in a timely manner. The 17-OHP immunoassay has been developed for diagnosing this condition. In a clinical guideline, the assay is recommended for screening in newborns, and several countries have implemented this as part of their screening programme. However, the originator of this application provided no evidence (i.e. no systematic reviews, no primary studies) relating to diagnostic accuracy or clinical utility. Furthermore, the costs are unclear, and it is also unclear how this assay relates to other diagnostic tests.
World Health Organization. (2023). The selection and use of essential in vitro diagnostics: report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/373322