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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



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


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.


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.


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.


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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

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