Establishment of allowable total error for semen analysis based on the state of the art in China
-
Yan Zheng
und
Fuping Li
Abstract
Objectives
To establish evidence-based analytical performance specifications (APS), specifically allowable total error (TEa), for five fundamental semen analysis parameters (sperm concentration, progressive motility, total motility, morphology, and vitality) in China utilizing the state-of-the-art model, and to compare these specifications with existing international benchmarks.
Methods
We examined national external quality assessment (EQA) data from 2019 to 2025, encompassing 315 laboratories across 30 provinces in China. TEa was calculated using the state-of-the-art model as half the 10th–90th percentile range of result deviations from assigned values. Given that the participant count was below 100 from 2019 to 2022, this study eventually utilized data from 2023 to 2025 for the calculation of TEa. The pass rate of participating laboratories was evaluated against the established TEa criteria.
Results
The established TEa values as follows: sperm concentration, 34.3 %; progressive motility, 26.9 % (for assigned value ≤40 %) and 13.5 % (>40 %); total motility, 26.3 % (≤50 %) and 10.5 % (>50 %); morphology, 67.7 %; vitality, 24.6 % (≤60 %) and 7.9 % (>60 %). The pass rates for all parameters in recent EQA cycles were approximately 80 %, supporting the practical achievability of the proposed specifications. Comparisons showed that the derived TEa values are generally consistent with or more refined than previous state-of-the-art and biological variation-based standards.
Conclusions
This study provides the first large-scale, evidence-based TEa for semen analysis in China. The stratified TEa for motility and vitality based on clinical thresholds, improves diagnostic accuracy. The proposed specifications are practical, achievable, and clinically relevant, providing a consistent foundation for quality assurance in reproductive medicine laboratories.
Funding source: Chengdu Municipal Health Commission
Award Identifier / Grant number: 2025160
Funding source: Health Commission of Sichuan Province Medical Science and Technology Program
Award Identifier / Grant number: 24SYJS01
Funding source: Sichuan Science and Technology Program
Award Identifier / Grant number: 2024NSFSC0647
-
Research ethics: The study protocol was approved by the Ethics Review Board of West China Second University Hospital of Sichuan University (IRB No. 2023-072).
-
Informed consent: Informed consent was obtained from the patients.
-
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. Yuan Liu performed statistical analysis and interpreted data. Yan Zheng draughted the article and revised it critically for important intellectual content. Fuping Li developed the original concept of this study collectively. Data collection were performed by Lin Yu, Yingbi Wu, Yelin Jia, Shasha Liu, Jiao Qin, Jintao Yuan. All authors have contributed to critical discussion and reviewed the final version of the manuscript.
-
Use of Large Language Models, AI and Machine Learning Tools: None declared.
-
Conflict of interest: The authors state no conflict of interest.
-
Research funding: Supported by Sichuan Science and Technology Program (2024NSFSC0647); Supported by Health Commission of Sichuan Province Medical Science and Technology Program (24SYJS01).
-
Data availability: Not applicable.
References
1. Agarwal, A, Baskaran, S, Parekh, N, Cho, CL, Henkel, R, Vij, S, et al.. Male infertility. Lancet 2021;397:319–33. https://doi.org/10.1016/s0140-6736(20)32667-2.Suche in Google Scholar PubMed
2. Zegers-Hochschild, F, Adamson, GD, Dyer, S, Racowsky, C, de Mouzon, J, Sokol, R, et al.. The international glossary on infertility and fertility care. Fertil Steril 2017;108:393–406. https://doi.org/10.1016/j.fertnstert.2017.06.005.Suche in Google Scholar PubMed
3. World Health Organization WHO. Laboratory manual for the examination and processing of human semen, 6th ed. Geneva, Switzerland: World Health Organization; 2021.Suche in Google Scholar
4. Sciacovelli, L, Padoan, A, Aita, A, Basso, D, Plebani, M. Quality indicators in laboratory medicine: state-of-the-art, quality specifications and future strategies. Clin Chem Lab Med 2023;61:688–95. https://doi.org/10.1515/cclm-2022-1143.Suche in Google Scholar PubMed
5. Sandberg, S, Coskun, A, Carobene, A, Fernandez-Calle, P, Diaz-Garzon, J, Bartlett, WA, et al.. Analytical performance specifications based on biological variation data - considerations, strengths and limitations. Clin Chem Lab Med 2024;62:1483–9. https://doi.org/10.1515/cclm-2024-0108.Suche in Google Scholar PubMed
6. Westgard, QC. CLIA acceptance limits for proficiency testing; 2024. https://westgard.com/clia-a-quality/quality-requirements/2024-cliarequirements.html.Suche in Google Scholar
7. Data innovation – total allowable error table (Updated June 2024). https://www.datainnovations.com/allowable-total-error-table.Suche in Google Scholar
8. Chenlo, P, Curi, S, Ariagno, J, Etchegoyen, C, Girardi, R, Mendeluk, G. Analytical quality specifications in semen analysis according to the state of the current methodologies. Clin Chem Lab Med 2022;60:1403–8. https://doi.org/10.1515/cclm-2022-0084.Suche in Google Scholar PubMed
9. Castilla, JAS, Morancho-Zaragoza, J, Aguilar, J, Prats-Gimenez, R, Gonzalvo, MC, Fernandez-Pardo, E, et al.. Quality specifications for seminal parameters based on the state of the art. Hum Reprod 2005;20:2573–8. https://doi.org/10.1093/humrep/dei061.Suche in Google Scholar PubMed
10. Alvarez, C, Castilla, JA, Molina, R, Ramı, ́rez JP, Vergara, F, Yoldi, A, et al.. Biological variation in seminal parameters in healthy subjects. Hum Reprod 2003;18:2082–8.10.1093/humrep/deg430Suche in Google Scholar PubMed
11. Zheng, Y, Wu, Y, Yu, L, Jia, Y, Yang, T, Cheng, Q, et al.. How has the external quality assessment/proficiency testing of semen analysis been developed in the past 34 years: a review. Clin Chem Lab Med 2024;63:670–83. https://doi.org/10.1515/cclm-2024-1062.Suche in Google Scholar PubMed
12. Sandberg, S, Fraser, CG, Horvath, AR, Jansen, R, Jones, G, Oosterhuis, W, et al.. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European Federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med 2015;53:833–5. https://doi.org/10.1515/cclm-2015-0067.Suche in Google Scholar PubMed
13. Zheng, Y, Wu, YB, Jia, YL, Ying, LJ, Yang, TT, Cheng, QY, et al.. External quality assessment scheme for sperm DNA fragmentation: a pilot study in China. Basic Clin Androl 2023;33:36. https://doi.org/10.1186/s12610-023-00211-0.Suche in Google Scholar PubMed PubMed Central
14. Wu, XY, Lu, JC, Peng, XH, He, JL, Wang, D, Dai, CL, et al.. Exploration of evaluation criteria based on the biological variation in the external quality assessment for basic semen analysis in China. Asian J Androl 2025;27:621–6. https://doi.org/10.4103/aja2024118.Suche in Google Scholar PubMed PubMed Central
15. Wang, QL, Jiang, SH, Ma, CJ, Zhong, KX, Zhuang, JM, Lin, DL, et al.. Evaluating an external quality assurance program for semen analysis in China during 2009–2020. Andrology 2022;10:1143–9. https://doi.org/10.1111/andr.13205.Suche in Google Scholar PubMed
16. Li, T, Wang, W, Zhao, H, He, F, Zhong, K, Yuan, S, et al.. Quality specification and status of internal quality control of cardiac biomarkers in China from 2011 to 2016. J Clin Lab Anal 2018;32:e22324. https://doi.org/10.1002/jcla.22324.Suche in Google Scholar PubMed PubMed Central
17. International Organization for Standardization (ISO). Basic semen examination – specification and test methods. Geneva, Switzerland: ISO; 2021. ISO 23162:2021.Suche in Google Scholar
Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2025-1222).
© 2025 Walter de Gruyter GmbH, Berlin/Boston
