Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter June 28, 2022

Analytical quality specifications in semen analysis according to the state of the current methodologies

  • Patricia Chenlo EMAIL logo , Susana Curi , Julia Ariagno , Cecilia Etchegoyen , Raul Girardi and Gabriela Mendeluk

Abstract

Objectives

The aim of this study was to establish analytical quality specifications for human semen measurands according to the state of the current methodologies.

Methods

Measurement errors were estimated based on data from participating laboratories in the External Quality Program (PEEC) led by the Argentine Biochemistry Foundation using the “Analytical Quality Minimum Specifications” model established in Spain for other biochemical collection parameters. Semen samples from the PEEC were analyzed according to WHO procedures.

Results

Analytical quality specifications were established according to the most recent results obtained by the External Quality Evaluation Program of the Fundación Bioquímica Argentina. Morphology, progressive motility, total motility and sperm concentration were 75%, 30%, 21% and 43%, respectively, for samples with assigned values between 6 and 15% of normal forms, 35–89% for progressive motility, 43–92% for total motility and for sperm count in the range of 1.8 × 106 –65 × 106 spermatozoa/mL.

Conclusions

Our allowable total error specification may affect medical conduct at certain dose levels, compromising clinical test validity. The measurement system employed is closely associated with the number of elements evaluated. The use of manual methods, where the fatigue of the operator counteracts their ability to evaluate a considerable number of elements, leads to errors typical of the poisson and binomial distribution characteristics of these measurands. This work reflects the laboratory performance in our region. The proposed specifications are a statement of minimums that every laboratory should comply with to ensure analytical performance of clinical utility with the current methodology available.


Corresponding author: Patricia Chenlo, Biochemist, Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Buenos Aires, Argentina, E-mail:

Funding source: UBACYT

Award Identifier / Grant number: 20720170100003BA

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The local Institutional Review Board deemed the study exempt from review.

References

1. Porras-Caicedo, A, Moreno, D, Lugo, O, Peña, K, Ibarguen, J, Amariles, A, et al.. Opciones para seleccionar límites analíticos de desempeño en el laboratorio clínico. Rev Latinoamer Patol Clin 2012;59:35–42.Search in Google Scholar

2. Clinical and Laboratory Standards Institute, CLSI. Statistical quality control for quantitative measurement procedures: principles and definitions, 4th ed. CLSI guideline C24. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.Search in Google Scholar

3. Kaplan, LA. Determination and application of desirable analytical performance goals: the ISO/TC 212 approach. Scand J Clin Lab Invest 1999;59:479–82. https://doi.org/10.1080/00365519950185193.Search in Google Scholar

4. Panteghini, M, Sandberg, S. Defining analytical performance specifications 15 years after the Stockholm conference. Clin Chem Lab Med 2015;53:829–32.10.1515/cclm-2015-0303Search in Google Scholar

5. Ricos, C, Alvarez, V, Cava, F, Garcia-Lario, JV, Hernandez, A, Jimenez, CV, et al.. Desirable specifications for total error, imprecision, and bias, derived from intra- and inter individual biologic variation. Scand J Clin Lab Invest 1999;59:491–500. (actualizado en 2014).Search in Google Scholar

6. Westgard, JO. Desirable biological variation database specifications [Internet]; 2014. Disponible de: https://www.westgard.com/biodatabase1.htm [Citado el 15 de Septiembre de 2021].Search in Google Scholar

7. Poland, ML, Moghissi, S, Giblin, PT, Ager, JW, Olson, JM. Variation of semen measures within normal men. Fertil Steril 1985;44:396–400. https://doi.org/10.1016/s0015-0282(16)48866-7.Search in Google Scholar

8. Cooper, TG, Jockenhovel, F, Nieschlag, E. Variations in semen parameters from fathers. Hum Reprod 1991;6:859–66. https://doi.org/10.1093/oxfordjournals.humrep.a137441.Search in Google Scholar PubMed

9. Tielemans, E, Heederik, D, Burdorf, A, Loomis, D, Dik, J, Habbema, F. Intraindividual variability and redundancy of semen parameters. Epidemiology 1997;8:99–103. https://doi.org/10.1097/00001648-199701000-00016.Search in Google Scholar PubMed

10. Alvarez, C, Castilla, JA, Martinez, L, Ramirez, JP, Vergara, F, Gaforio, JJ. Biological variation of seminal parameters in healthy subjects. Hum Reprod 2003;18:2082–8. https://doi.org/10.1093/humrep/deg430.Search in Google Scholar PubMed

11. Keel, BA. Within- and between-subject variation in semen parameters in infertile men and normal semen donors. Fertil Steril 2006;85:128–34. https://doi.org/10.1016/j.fertnstert.2005.06.048.Search in Google Scholar PubMed

12. Bartlett, WA, Braga, F, Carobene, A, Coskun, A, Prusa, R, Fernandez-Calle, P, et al.. Biological variation critical appraisal checklist (BioVarC) A checklist for critical appraisal of studies of biological variation. Clin Chem Lab Med 2015;53:879–85.10.1515/cclm-2014-1127Search in Google Scholar PubMed

13. Palacios, ER, Gonzalvo, MC, Clavero, A, Ramirez, JP, Rosales, A, Mozas, J, et al.. Aplicaciones de las especificaciones de calidad analítica al cálculo de los límites admisibles de error en programas de evaluación externa de calidad para concentración espermática. Rev. Lab. Clin. 2011;4:134–44. https://doi.org/10.1016/j.labcli.2011.03.003.Search in Google Scholar

14. 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.Search in Google Scholar PubMed

15. Data innovations. Available from: https://www.datainnovations.com/allowable-total-error-table.Search in Google Scholar

16. Etchegoyen, MC, Prevoo, MM, Girardi, RH. Programa de evaluación externa de la calidad “Prof. Dr. Daniel Mazziotta”: una nueva etapa asegurando la mejora continua de la calidad. Acta Bioquim Clin Latinoam 2019;53:499–504.Search in Google Scholar

17. World Health Organization WHO. Laboratory manual for the examination and processing of human semen, 5th ed Geneva, Switzerland: World Health Organization; 2010.Search in Google Scholar

18. Peruzzetto, C, Grammatico, J, Valdata, C. Programa de Acreditación de Laboratorios: contribuyendo a la calidad de los laboratorios en Argentina por más de 22 años. Acta Bioquím Clín Latinoam 2016;50:721–32.Search in Google Scholar

19. Salas, A, Ricos, C, Prada, E, Ramon, F, Morancho, J, Jou, JM, et al.. State-of-the-art approach to goal setting. Clin Lab Med 2016;37:73–84. https://doi.org/10.1016/j.cll.2016.09.007.Search in Google Scholar PubMed

20. Clar, CR, Bassini, GG, Turallas, JMJ, Zaragoza, JM, Bauza, FR, Aguila, CR, et al.. Revista del Laboratorio Clínico. Consenso sobre especificaciones mínimas de calidad analítica para magnitudes hematológicas y de bioquímica especial. Rev Lab Clin 2010;3:87–93.10.1016/j.labcli.2010.02.002Search in Google Scholar

21. Ariagno, J, Curi, S, Chenlo, P, Repetto, H, Pugliese, N, Palaoro, L, et al.. Our experience in sperm morphology assessment. Asian J Androl 2011;13:201–2. https://doi.org/10.1038/aja.2010.119.Search in Google Scholar PubMed PubMed Central

22. World Health Organization. WHO laboratory manual for the examination and processing of human semen, 6th ed Geneva, Switzerland: World Health Organization; 2021.Search in Google Scholar

23. ISO 23162:2021. Basic semen examination — specification and test methods. In: Technical committee ISO/TC 212, 1st ed. Clinical Laboratory Testing and in vitro Diagnostic Test Systems ICS: 11.100.01 Laboratory Medicine in General:32 p. Geneva, Switzerland.Search in Google Scholar

24. Chenlo, P, Curi, S, Pugliese, N, Avendaño, C, Munuce, M, Ariagno, J, et al.. Acreditación de los laboratorios de andrología en la república argentina. Acta Bioquim Clin Latinoam 2019;53:315–21.Search in Google Scholar

25. EP15-A3. User verification of precision and estimation of bias; approved guideline, 3rd ed USA: Clinical and Laboratory Standards Institute; 2014.Search in Google Scholar

26. Curi, S, Ariagno, J, Chenlo, P, Pugliese, M, Segovia, S, Repetto, H, et al.. Control de calidad externo en el estudio del semen. Acta Bioquim Clin Latinoam 2008;42:183–7.Search in Google Scholar

27. ISO 15189. Specifies requirements for quality and competence particular to medical laboratories. ISO Geneva, Switzerland. 2012. p. 1–58.Search in Google Scholar

Received: 2022-02-01
Accepted: 2022-06-09
Published Online: 2022-06-28
Published in Print: 2022-08-26

© 2022 Walter de Gruyter GmbH, Berlin/Boston

Downloaded on 4.3.2024 from https://www.degruyter.com/document/doi/10.1515/cclm-2022-0084/html
Scroll to top button