Quality specifications for seminal parameters based on the state of the art

BACKGROUND: The aim of this study was to calculate the analytical goal for seminal parameters based on the state of the art, and then to compare these specifications with those previously obtained by our group based on biological variation. METHODS: All data used for analysis were derived from the Spanish programme of external quality control on semen analysis. Over 90 laboratories participated from 1999 to 2003. Using graphs of the state of the art, we also determined the numbers of laboratories that achieved quality specifications. RESULTS: The total allowable error calculated using state of the art graphs is similar to that calculated using biological variation for concentration and total motility. However, it is much higher for morphology and rapidly progressive motility. Over 80% of the laboratories achieved the minimum quality specification based on biological variation for concentration, total and progressive motility. However, only ∼30% of the laboratories achieved the minimum quality specification based on biological variation for morphology and rapidly progressive motility. CONCLUSIONS: The study enabled us to identify the state of the art of analytical performance for seminal parameters, and revealed the difficulty inherent in meeting the quality specifications based on biological variation.