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

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 × 10 6 –65 × 10 6 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.