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. 2023 Mar 9;4(1):52-69.
doi: 10.1515/almed-2023-0020. eCollection 2023 Apr.

Recommendations for the measurement of sexual steroids in clinical practice. A position statement of SEQCML/SEEN/SEEP

[Article in English, Spanish]
Affiliations

Recommendations for the measurement of sexual steroids in clinical practice. A position statement of SEQCML/SEEN/SEEP

[Article in English, Spanish]
Gregori Casals et al. Adv Lab Med. .

Abstract

The proper clinical approach to a wide range of disorders relies on the availability of accurate, reproducible laboratory results for sexual steroids measured using methods with a high specificity and sensitivity. The chemiluminescent immunoassays currently available have analytical limitations with significant clinical implications. This position statement reviews the current limitations of laboratory techniques for the measurement of estradiol and testosterone and their impact on diverse clinical scenarios. A set of recommendations are provided to incorporate steroid hormone analysis by mass spectrometry in national health systems. International societies have recommended this methodology for a decade.

Keywords: estradiol; immunoassay; mass spectrometry; sexual steroids; testosterone.

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Conflict of interest statement

Competing interests: Authors state no conflict of interest.

Figures

Figure 1:
Figure 1:
Immunoassays. (A–C) Example of competitive chemiluminiscence immunoassay. (A) By this method, a specific antibody recognizes the analyte of interest. (B) The antibody is incubated with the sample (containing the analyte of interest and other molecules) and with the labeled analyte. The analyte and labeled analyte compete for antibody binding sites. (C) The chemiluminiscence signal generated by the bound labeled analyte is recorded. In this example, the recorded signal will be inversely proportional to the amount of analyte initially present in the sample. (D-H) Mass spectrometry. Example of liquid chromatography tandem-mass spectrometry (LC-MS/MS). (D) and (E) Extraction of a serum sample using an organic solvent. This step eliminates potential interferences. (F) Separation of sample components by liquid chromatography. (G) Selection of analyte-specific ions. (H) Representation of results. The chromatographic peak area is directly proportional to the amount of the analyte initially present in the sample.
Figure 2:
Figure 2:
Advantages and limitations of immunoassay and mass spectrometry based methods.
Figure 3:
Figure 3:
Number of laboratories that measure testosterone and estradiol by chemoluminiscent immunoassays (IA), mass spectrometry (MS), and radioimmunoassays (RIA) in accordance with the European External Quality Control Program of the Referenzinstitut für Bioanalytk, Germany.

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