Analytical quality specifications in semen analysis according to the state of the current methodologies
-
Patricia Chenlo
,
Susana Curi
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.
Funding source: UBACYT
Award Identifier / Grant number: 20720170100003BA
-
Research funding: None declared.
-
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Competing interests: Authors state no conflict of interest.
-
Informed consent: Informed consent was obtained from all individuals included in this study.
-
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
© 2022 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorials
- Clinical Chemistry and Laboratory Medicine: enjoying the present and assessing the future
- Rethinking internal quality control: the time is now
- Review
- Multi-omics analysis from archival neonatal dried blood spots: limitations and opportunities
- Opinion Papers
- ‘Penelope test’: a practical instrument for checking appropriateness of laboratory tests
- Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?
- EFLM Paper
- Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- General Clinical Chemistry and Laboratory Medicine
- Cross-reactivity in assays for prolactin and optimum screening policy for macroprolactinaemia
- Repository of intra- and inter-run variations of quantitative autoantibody assays: a European multicenter study
- Stability of direct renin concentration and plasma renin activity in EDTA whole blood and plasma at ambient and refrigerated temperatures from 0 to 72 hours
- Comparison of four different immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry assay for serum folate
- Analytical quality specifications in semen analysis according to the state of the current methodologies
- Reference Values and Biological Variations
- Short-term biological variation study of plasma hemophilia and thrombophilia parameters in a population of apparently healthy Caucasian adults
- First morning voided urinary gonadotropins in children: verification of method performance and establishment of reference intervals
- Derivation of sex and age-specific reference intervals for clinical chemistry analytes in healthy Ghanaian adults
- Cancer Diagnostics
- Serum free light chain analysis: persisting limitations with new kids on the block
- Cardiovascular Diseases
- Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort
- The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions
- Infectious Diseases
- Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2
- Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay
- Presepsin levels in neonatal cord blood are not influenced by maternal SARS-CoV-2 infection
- Letters to the Editors
- How to evaluate fixed clinical QC limits vs. risk-based SQC strategies
- Reply to Westgard et al.: ‘Keep your eyes wide … as the present now will later be past’*
- Platelet phagocytosis by monocytes
- Early detection of Candida parapsilosis in peripheral blood as a result of a peripheral blood smear performed after cytographic changes on the Beckman Coulter UniCel DxH 800 hematology
- Pseudo-erythroblastosis on Sysmex XN hematology analyzers: a clue to Candida sepsis. Case report and literature review
- Covert poisoning with difenacoum: diagnosis and follow-up difficulties
- Comparison of Sebia Capillarys 3-OCTA with the Tosoh Bioscience HLC®-723G8 method for A1C testing with focus on analytical interferences and variant detection
Articles in the same Issue
- Frontmatter
- Editorials
- Clinical Chemistry and Laboratory Medicine: enjoying the present and assessing the future
- Rethinking internal quality control: the time is now
- Review
- Multi-omics analysis from archival neonatal dried blood spots: limitations and opportunities
- Opinion Papers
- ‘Penelope test’: a practical instrument for checking appropriateness of laboratory tests
- Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?
- EFLM Paper
- Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- General Clinical Chemistry and Laboratory Medicine
- Cross-reactivity in assays for prolactin and optimum screening policy for macroprolactinaemia
- Repository of intra- and inter-run variations of quantitative autoantibody assays: a European multicenter study
- Stability of direct renin concentration and plasma renin activity in EDTA whole blood and plasma at ambient and refrigerated temperatures from 0 to 72 hours
- Comparison of four different immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry assay for serum folate
- Analytical quality specifications in semen analysis according to the state of the current methodologies
- Reference Values and Biological Variations
- Short-term biological variation study of plasma hemophilia and thrombophilia parameters in a population of apparently healthy Caucasian adults
- First morning voided urinary gonadotropins in children: verification of method performance and establishment of reference intervals
- Derivation of sex and age-specific reference intervals for clinical chemistry analytes in healthy Ghanaian adults
- Cancer Diagnostics
- Serum free light chain analysis: persisting limitations with new kids on the block
- Cardiovascular Diseases
- Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort
- The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions
- Infectious Diseases
- Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2
- Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay
- Presepsin levels in neonatal cord blood are not influenced by maternal SARS-CoV-2 infection
- Letters to the Editors
- How to evaluate fixed clinical QC limits vs. risk-based SQC strategies
- Reply to Westgard et al.: ‘Keep your eyes wide … as the present now will later be past’*
- Platelet phagocytosis by monocytes
- Early detection of Candida parapsilosis in peripheral blood as a result of a peripheral blood smear performed after cytographic changes on the Beckman Coulter UniCel DxH 800 hematology
- Pseudo-erythroblastosis on Sysmex XN hematology analyzers: a clue to Candida sepsis. Case report and literature review
- Covert poisoning with difenacoum: diagnosis and follow-up difficulties
- Comparison of Sebia Capillarys 3-OCTA with the Tosoh Bioscience HLC®-723G8 method for A1C testing with focus on analytical interferences and variant detection
