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 sam...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-12-01
|
| Series: | F&S Reports |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666334124001181 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850104564535001088 |
|---|---|
| author | Karen Racicot, Ph.D. Denny Sakkas, Ph.D. Brent C. Barrett, Ph.D. Kenneth Chiang, Ph.D. Charles Jenkins, B.S. |
| author_facet | Karen Racicot, Ph.D. Denny Sakkas, Ph.D. Brent C. Barrett, Ph.D. Kenneth Chiang, Ph.D. Charles Jenkins, B.S. |
| author_sort | Karen Racicot, Ph.D. |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-8b2247b6708a42d89a84dad381a10be7 |
| institution | DOAJ |
| issn | 2666-3341 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | F&S Reports |
| spelling | doaj-art-8b2247b6708a42d89a84dad381a10be72025-08-20T02:39:18ZengElsevierF&S Reports2666-33412024-12-015437838410.1016/j.xfre.2024.10.005Validation of a mail-in delayed semen analysis protocol developed for home collectionKaren Racicot, Ph.D.0Denny Sakkas, Ph.D.1Brent C. Barrett, Ph.D.2Kenneth Chiang, Ph.D.3Charles Jenkins, B.S.4Quest Diagnostics, Secaucus, New Jersey; ReproSource, Marlborough, Massachusetts; Correspondence: Karen Racicot, Ph.D., Quest Diagnostics, 500 Plaza Dr, Secaucus, New Jersey 07094.Boston IVF IVIRMA-Global Research Alliance, Waltham, MassachusettsBoston IVF IVIRMA-Global Research Alliance, Waltham, MassachusettsIndependent, Irvine, CaliforniaQuest Diagnostics, Secaucus, New Jersey; ReproSource, Marlborough, MassachusettsObjective: 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.http://www.sciencedirect.com/science/article/pii/S2666334124001181Semen analysisspermatozoamale infertilityhome collectionmail-in |
| spellingShingle | Karen Racicot, Ph.D. Denny Sakkas, Ph.D. Brent C. Barrett, Ph.D. Kenneth Chiang, Ph.D. Charles Jenkins, B.S. Validation of a mail-in delayed semen analysis protocol developed for home collection F&S Reports Semen analysis spermatozoa male infertility home collection mail-in |
| title | Validation of a mail-in delayed semen analysis protocol developed for home collection |
| title_full | Validation of a mail-in delayed semen analysis protocol developed for home collection |
| title_fullStr | Validation of a mail-in delayed semen analysis protocol developed for home collection |
| title_full_unstemmed | Validation of a mail-in delayed semen analysis protocol developed for home collection |
| title_short | Validation of a mail-in delayed semen analysis protocol developed for home collection |
| title_sort | validation of a mail in delayed semen analysis protocol developed for home collection |
| topic | Semen analysis spermatozoa male infertility home collection mail-in |
| url | http://www.sciencedirect.com/science/article/pii/S2666334124001181 |
| work_keys_str_mv | AT karenracicotphd validationofamailindelayedsemenanalysisprotocoldevelopedforhomecollection AT dennysakkasphd validationofamailindelayedsemenanalysisprotocoldevelopedforhomecollection AT brentcbarrettphd validationofamailindelayedsemenanalysisprotocoldevelopedforhomecollection AT kennethchiangphd validationofamailindelayedsemenanalysisprotocoldevelopedforhomecollection AT charlesjenkinsbs validationofamailindelayedsemenanalysisprotocoldevelopedforhomecollection |