Validation of a mail-in delayed semen analysis protocol developed for home collection

Objective

To validate a mail-in delayed semen analysis service using deidentified remnant samples from a US fertility clinic.

Design

Double-blinded prospective validation of screening/diagnostic test.

Setting

Fertility clinic and clinical reference laboratory.

Patient(s)

Deidentified remnant samples from patients attending fertility clinic for fertility assessment (study A, n = 68; study B, n = 232).

Intervention(s)

None.

Main Outcome Measure(s)

Total motility, concentration, and morphology (Kruger, strict) measures were compared between split semen specimens that underwent comprehensive semen analysis at <1 hour (referent) and 26 hours (experimental). The concordance between the paired measures was described using coefficient of variance and percent bias. Clinical concordance (CC) between 1- and 26-hour results for total motility, concentration, and morphology measures was also reported, using the fifth centile clinical reference ranges described in the World Health Organization manual (fifth edition).

Result(s)

In a controlled laboratory setting (study A), total motility, concentration, and morphology measures were highly consistent between the 1- and 26-hour analyses, with mean coefficients of variation (%CVs) of 9.0% for total motility, 4.0% for concentration, and 3.0% for morphology. There were also high CC rates: 94.2% for total motility; 100% for concentration; and 98.5% for morphology. In a real-world setting (study B), which included commercial shipment of specimens, the mean %CVs for total motility and concentration were 15% and 27%, respectively, which were more variable than those in study A yet still considerably less variable than that measured between laboratories using College of Anatomical Pathologist proficiency testing during the study period (motility %CV, 31%; concentration %CV, 37%). These comparisons also had high CC rates for total motility (86%) and concentration (93.1%).

Conclusion(s)

These results demonstrate the validation of a laboratory service that provides accurate, comprehensive semen analysis on specimens collected remotely and shipped overnight to a clinical diagnostic laboratory.