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Hum. Reprod. Advance Access originally published online on December 16, 2005
Human Reproduction 2006 21(4):847-851; doi:10.1093/humrep/dei423
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

DEBATE CONTINUED

Influence of analytical and biological variation on the clinical interpretation of seminal parameters

J.A. Castilla1,5, C. Álvarez2, J. Aguilar3, C. González-Varea1, M.C. Gonzalvo4 and L. Martínez1

1 Unidad de Reproducción, Hospital Virgen de las Nieves, Granada, 2 Departamento de Ciencias de la Salud, Universidad de Jaén, Jaén, 3 Unidad de Reproducción, Clínica Avicena, Jaén and 4 Laboratorio CEIFER, Granada, Spain

5 To whom correspondence should be addressed at: Unidad de Reproducción, Hospital Virgen de las Nieves, E-18014, Granada, Spain. E-mail: josea.castilla.sspa{at}juntadeandalucia.es

Quality assurance in semen analysis has been questioned recently in this journal. Based on the limited capacity of seminal parameter in the determination of fertility, the authors advocated abandoning methods of quality assurance in semen analysis for clinical situations. In this article, we explore arguments as to why quality assurance in semen analysis for clinical use is not ‘a waste of time’. Imprecision and within-subject biological variations are the two major components involved in the dispersion of seminal parameter results obtained by analysis of a semen sample from an individual. As within-subject biological variation is constant across geography, time and population, imprecision is a very important factor in the quality of laboratory test results. We analyse this influence on various seminal parameters and observe that there is an amount of error that can be tolerated without invalidating the medical usefulness of seminal parameter determination. However, there is a maximum allowable analytical error above which the medical usefulness of seminal parameter results is invalidated. The level of performance required to facilitate clinical decision-making is termed quality specification. We comment on different strategies to define the maximum allowable analytical error.

Key words: analytical variation/biological variation/quality specification/semen analysis


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