{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T11:36:03Z","timestamp":1785411363128,"version":"3.56.0"},"reference-count":17,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T00:00:00Z","timestamp":1779753600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013128","name":"Korea Technology and Information Promotion Agency for SMEs","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100013128","id-type":"DOI","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/02kxx1z36","id-type":"ROR","asserted-by":"publisher"}]},{"name":"Korea Health Technology R&D Project"},{"DOI":"10.13039\/501100003710","name":"Korea Health Industry Development Institute","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100003710","id-type":"DOI","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/00fdzyk40","id-type":"ROR","asserted-by":"publisher"}]},{"name":"Ministry of Health & Welfare, Republic of Korea","award":["RS-2025-02183084"],"award-info":[{"award-number":["RS-2025-02183084"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Male factor infertility contributes to approximately 40\u201350% of infertility cases globally, yet traditional laboratory-based semen analysis often imposes logistical and psychological barriers. This study aimed to evaluate the analytical performance and diagnostic concordance of a novel smartphone-based point-of-care testing (POCT) system, Hagobogo Pro, compared with a laboratory-based computer-assisted sperm analysis (CASA) reference system. Methods: This retrospective validation study analyzed 520 video microscopy clips obtained from 104 men undergoing infertility evaluation at a tertiary fertility center. Following World Health Organization (WHO) 2021 guidelines, sperm concentration and total motility were measured using the Hagobogo Pro smartphone device and the reference system. Analytical performance was assessed based on intra-assay precision, operational time, and method agreement using Passing\u2013Bablok regression, Bland\u2013Altman analysis, and Spearman correlation. Results: The smartphone-based system demonstrated strong analytical agreement with the CASA reference, with high correlations observed for sperm concentration (\u03c1 = 0.943) and motility (\u03c1 = 0.7335). Bland\u2013Altman analysis indicated minimal systematic bias, and intra-assay precision showed coefficients of variation below 6%. There were no statistically significant differences in mean parameters between the smartphone device, CASA, and manual assessment. Conclusions: The Hagobogo Pro platform enables rapid, reliable, and standardized sperm concentration and motility quantification, and results showed good agreement with laboratory CASA. While not a replacement for holistic laboratory evaluations, this technology improves access to preliminary male fertility screening and may empower patients by mitigating barriers to initial testing.<\/jats:p>","DOI":"10.3390\/diagnostics16111631","type":"journal-article","created":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T16:17:58Z","timestamp":1779812278000},"page":"1631","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Validation of a Novel Smartphone-Based Point-of-Care Semen Analysis System to Evaluate Male Reproductive Potential: A Concordance Study with Computer-Assisted Sperm Analysis"],"prefix":"10.3390","volume":"16","author":[{"given":"Byeong Jun","family":"Mun","sequence":"first","affiliation":[{"name":"Department of Biomedical Science, College of Life Science, CHA University, Pocheon 11160, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seung A","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Life Science, CHA University, Pocheon 11160, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin Young","family":"An","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Life Science, CHA University, Pocheon 11160, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seong Jung","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Life Science, CHA University, Pocheon 11160, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu Ha","family":"Shim","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Life Science, CHA University, Pocheon 11160, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji Soo","family":"Ryu","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Life Science, CHA University, Pocheon 11160, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-4583-4780","authenticated-orcid":false,"given":"Hyun Seung","family":"Lee","sequence":"additional","affiliation":[{"name":"CHA Fertility Center, Seoul Station, Hangang-daero, Jung-gu, Seoul 04637, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae Eun","family":"Shin","sequence":"additional","affiliation":[{"name":"CHA Fertility Center, Seoul Station, Hangang-daero, Jung-gu, Seoul 04637, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji Hoon","family":"Kim","sequence":"additional","affiliation":[{"name":"INTIN Inc., 52, Cheombok-ro, Dong-gu, Daegu 41068, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu Jin","family":"Lee","sequence":"additional","affiliation":[{"name":"INTIN Inc., 52, Cheombok-ro, Dong-gu, Daegu 41068, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun Ho","family":"Ji","sequence":"additional","affiliation":[{"name":"INTIN Inc., 52, Cheombok-ro, Dong-gu, Daegu 41068, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3237-6304","authenticated-orcid":false,"given":"Dae Keun","family":"Kim","sequence":"additional","affiliation":[{"name":"CHA Fertility Center, Seoul Station, Hangang-daero, Jung-gu, Seoul 04637, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8735-444X","authenticated-orcid":false,"given":"Jae Ho","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Life Science, CHA University, Pocheon 11160, Republic of Korea"},{"name":"CHA Fertility Center, Seoul Station, Hangang-daero, Jung-gu, Seoul 04637, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,5,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"265","DOI":"10.5534\/wjmh.240069","article-title":"Contemporary Diagnostic Work-Up for Male Infertility: Emphasizing Comprehensive Baseline Assessment","volume":"43","author":"Pozzi","year":"2025","journal-title":"World J. Mens. Health"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"e20250180","DOI":"10.1590\/s1677-5538.ibju.2025.0180","article-title":"Integrating Quality Management and Male Reproductive Health in Assisted Reproduction","volume":"51","author":"Bento","year":"2025","journal-title":"Int. Braz. J. Urol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"41","DOI":"10.4103\/0970-1591.78424","article-title":"Semen analysis and sperm function tests: How much to test?","volume":"27","author":"Vasan","year":"2011","journal-title":"Indian J. Urol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1502","DOI":"10.1016\/j.fertnstert.2014.10.021","article-title":"Limitations of semen analysis as a test of male fertility and anticipated needs from newer tests","volume":"102","author":"Wang","year":"2014","journal-title":"Fertil. Steril."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"458","DOI":"10.1093\/humupd\/dmx005","article-title":"Men\u2019s knowledge, attitudes and behaviours relating to fertility","volume":"23","author":"Hammarberg","year":"2017","journal-title":"Hum. Reprod. Update"},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Tesarik, J. (2025). Lifestyle and Environmental Factors Affecting Male Fertility, Individual Predisposition, Prevention, and Intervention. Int. J. Mol. Sci., 26.","DOI":"10.20944\/preprints202503.1302.v1"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"763","DOI":"10.1111\/andr.12209","article-title":"Uncertainty of measurement and clinical value of semen analysis: Has standardisation through professional guidelines helped or hindered progress?","volume":"4","author":"Tomlinson","year":"2016","journal-title":"Andrology"},{"key":"ref_8","unstructured":"World Health Organization (2021). 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Urol."}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/16\/11\/1631\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T04:17:31Z","timestamp":1779941851000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/16\/11\/1631"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,26]]},"references-count":17,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2026,6]]}},"alternative-id":["diagnostics16111631"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics16111631","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,26]]}}}