F&S reports · 2024
Validation of a mail-in delayed semen analysis protocol developed for home collection.
СтатьяНазвание и аннотация: Перевод в очереди
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Racicot Karen, Sakkas Denny, Barrett Brent C, Chiang Kenneth, Jenkins Charles
Аннотация
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.
PATIENTS: Deidentified remnant samples from patients attending fertility clinic for fertility assessment (study A, n = 68; study B, n = 232).
INTERVENTIONS: None.
MAIN OUTCOME MEASURES: 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).
RESULTS: 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%).
CONCLUSIONS: 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.
DESIGN: Double-blinded prospective validation of screening/diagnostic test.
SETTING: Fertility clinic and clinical reference laboratory.
PATIENTS: Deidentified remnant samples from patients attending fertility clinic for fertility assessment (study A, n = 68; study B, n = 232).
INTERVENTIONS: None.
MAIN OUTCOME MEASURES: 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).
RESULTS: 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%).
CONCLUSIONS: 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.