Fertility diagnostics at the heart of modern immunochemistry

From clinical questions to scalable laboratory strategies

Infertility is a relevant medical issue that is becoming increasingly important for clinics and laboratories. According to the World Health Organization (WHO), approximately one in six people of reproductive age worldwide are affected¹. Accordingly, international professional societies such as ESHRE and ASRM recommend structured, timely fertility diagnostics as the basis for evidence-based therapy decisions² ³.

For physicians, the focus is on clinically relevant, reproducible hormone findings. For laboratory managers, turnaround times, methodological consistency, and scalability are becoming increasingly important. Modern immunochemistry platforms play a central role here, especially when fertility diagnostics are not viewed in isolation, but as an entry point into an expanded endocrinological and reproductive medicine diagnostic portfolio.

Why fertility diagnostics meet more requirements today than in the past

In practice, diagnostic clarification of fertility disorders is rarely limited to individual parameters. Further questions often follow, for example, regarding endocrinological involvement, metabolic influencing factors, or the course of reproductive medicine therapies.

This increases the demands on laboratory diagnostics:

Results must be available promptly, methodologically consistent, and comparable across diagnostic phases. At the same time, many institutions expect an infrastructure that can be expanded to meet growing diagnostic needs without fragmenting existing processes.

 

Fertility diagnostics: clinically established – time-critical

Established cycle hormones form the basis of fertility diagnostics. In addition, anti-Müllerian hormone (AMH) in particular has established itself as a robust marker for estimating ovarian reserve. AMH has low cycle dependency and is described in guidelines as a useful component of fertility assessment, always in the context of the overall clinical situation. In healthcare practice, it is not only the selection of the parameter that is crucial, but also the timely availability of results. Delays due to external analysis can complicate treatment decisions and affect sensitive time windows. Many institutions therefore decide to map central fertility markers in their own laboratories. Compact CLIA systems such as MAGLUMI X3 are designed for such decentralized structures and enable timely provision of findings using standardized methodology (manufacturer's specifications).

 

 

When fertility and endocrinology converge

Fertility disorders are often associated with accompanying endocrinological factors. Current guidelines recommend structured hormonal and metabolic testing, especially when polycystic ovary syndrome (PCOS) is suspected⁵. It is essential for physicians that different hormone parameters are methodologically comparable. At the same time, laboratory managers are faced with the question of how this broad diagnostic spectrum can be efficiently mapped without having to operate several systems in parallel. Platforms such as MAGLUMI X6, which combine fertility and advanced endocrinological markers on a uniform CLIA methodology, support this consolidated approach (manufacturer's specifications).

The analytical performance was examined for thyroid parameters, among other things: An independent verification and method comparison study showed good overall precision and agreement with established reference values for TSH and free thyroxine (fT4).

 

 

Reproductive medicine: Diagnostics under time pressure

In IVF centers, hormonal findings are often decisive for immediate treatment decisions. Values such as estradiol, LH, or progesterone must be available within narrow time windows in order to make reliable decisions about stimulation or transfer. In addition to pure throughput, the stability of laboratory processes under load is therefore a key criterion. High-throughput systems such as MAGLUMI X8 or X10 are designed for such scenarios and enable the parallel processing of routine and time-critical samples (manufacturer's specifications). Evidence of the methodological robustness of the underlying CLIA technology can also be found outside the field of fertility diagnostics: In a recent method comparison study, tacrolimus measurements on the MAGLUMI platform showed good agreement with an established CMIA system⁷. Although this study comes from the field of therapeutic drug monitoring, it underscores the analytical stability of the platform.

 

 

 

From entry to strategy: growth without system disruption

Many laboratories start with a focused fertility panel. However, it is crucial that this entry point remains expandable in the long term. A scalable immunochemistry platform makes it possible to gradually expand the diagnostic spectrum—for example, in the direction of endocrinology, pregnancy monitoring, or specialized reproductive medicine diagnostics—without changing the methodological basis. The MAGLUMI-X series is designed accordingly as a tiered platform: from a compact entry-level system to a high-throughput solution for central laboratories (manufacturer's specifications).

 

Clinic and laboratory designed together

Today, modern fertility diagnostics is often the beginning of a more complex diagnostic path. Platforms that go beyond classic basic parameters and enable consistent, scalable immunochemistry support both clinical decision-making processes and stable laboratory workflows. For physicians, this means timely, comparable findings.

For laboratory managers, this opens up the possibility of building diagnostic depth without having to accept structural breaks in the workflow.

 

Literature

1. World Health Organization (WHO). Infertility prevalence estimates, 1990–2021 (2023).
https://www.who.int/news-room/fact-sheets/detail/infertility

2. European Society of Human Reproduction and Embryology (ESHRE). Guidelines on fertility assessment and management.
https://www.eshre.eu/Guidelines-and-Legal/Guidelines

3. American Society for Reproductive Medicine (ASRM). Testing and interpreting measures of ovarian reserve. Fertil Steril. 2020.
https://pubmed.ncbi.nlm.nih.gov/32222417/

4. Broer SL et al. Anti-Müllerian hormone: ovarian reserve testing. Endocr Rev. 2014.
https://pubmed.ncbi.nlm.nih.gov/24423320/

5. International PCOS Network. Evidence-based guideline for the assessment and management of PCOS. JCEM. 2023.
https://academic.oup.com/jcem/article/108/10/2447/7223068

6. Deniz L et al. Analytical verification of the MAGLUMI X8 for TSH and FT4. Clin Chem Lab Med. 2025.
https://pubmed.ncbi.nlm.nih.gov/40387742/

7. Sharma VK et al. Tacrolimus levels determined by two immunoassays. Clin Biochem. 2025.
https://pubmed.ncbi.nlm.nih.gov/41029032/

8. SNIBE Diagnostics. MAGLUMI X-Series – Product information.
https://www.snibe.com/en/products/maglumi.html