José Luis Rodríguez-Rivera, Alondra Daniel-Cravioto, Gamaliel Benítez-Arvizu
{"title":"[Screening of Hepatitis C virus in blood donors over 11 years].","authors":"José Luis Rodríguez-Rivera, Alondra Daniel-Cravioto, Gamaliel Benítez-Arvizu","doi":"10.5281/zenodo.19076194","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>HCV infection remains a global concern due to its often asymptomatic course and the potential for transfusion transmission during the window period. In this setting, nucleic acid testing (NAT) can detect early viremia that is not yet identifiable by serology, thereby strengthening blood safety.</p><p><strong>Objective: </strong>To quantify HCV NAT yield (NAT-reactive donations with non-reactive anti-HCV serology, consistent with window-period detection) in blood donors using combined NAT and serology over an 11-year period.</p><p><strong>Material and methods: </strong>Cross-sectional, observational study including 568,569 donations recorded at the CMN Siglo XXI Blood Bank (2014-2025). NAT and serology results were analyzed in accordance with NOM-253-SSA1-2012 to identify donations with a NAT-reactive/serology-non-reactive pattern.</p><p><strong>Results: </strong>One NAT-reactive/serology-non-reactive case was identified, consistent with window-period infection. The NAT yield rate was 0.18 per 100,000 donations (1.8 per million). No risk factors or coinfections were reported, indicating that serology alone would have missed the infection. Because only one case was documented over 11 years, population-level inferences and epidemiologic impact estimates are not supported.</p><p><strong>Conclusions: </strong>In a large cohort within a very low-frequency setting, NAT identified a potentially infectious donation that serology did not detect. Although the absolute yield was low, each detected case is relevant to transfusion safety. Expanding NAT coverage and strengthening voluntary donation are recommended to optimize transfusion safety in Mexico.</p>","PeriodicalId":94200,"journal":{"name":"Revista medica del Instituto Mexicano del Seguro Social","volume":"64 4","pages":"e7025"},"PeriodicalIF":0.0000,"publicationDate":"2026-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13378682/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revista medica del Instituto Mexicano del Seguro Social","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5281/zenodo.19076194","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: HCV infection remains a global concern due to its often asymptomatic course and the potential for transfusion transmission during the window period. In this setting, nucleic acid testing (NAT) can detect early viremia that is not yet identifiable by serology, thereby strengthening blood safety.
Objective: To quantify HCV NAT yield (NAT-reactive donations with non-reactive anti-HCV serology, consistent with window-period detection) in blood donors using combined NAT and serology over an 11-year period.
Material and methods: Cross-sectional, observational study including 568,569 donations recorded at the CMN Siglo XXI Blood Bank (2014-2025). NAT and serology results were analyzed in accordance with NOM-253-SSA1-2012 to identify donations with a NAT-reactive/serology-non-reactive pattern.
Results: One NAT-reactive/serology-non-reactive case was identified, consistent with window-period infection. The NAT yield rate was 0.18 per 100,000 donations (1.8 per million). No risk factors or coinfections were reported, indicating that serology alone would have missed the infection. Because only one case was documented over 11 years, population-level inferences and epidemiologic impact estimates are not supported.
Conclusions: In a large cohort within a very low-frequency setting, NAT identified a potentially infectious donation that serology did not detect. Although the absolute yield was low, each detected case is relevant to transfusion safety. Expanding NAT coverage and strengthening voluntary donation are recommended to optimize transfusion safety in Mexico.
背景:HCV感染仍然是一个全球关注的问题,由于其通常无症状的过程和潜在的窗口期输血传播。在这种情况下,核酸检测(NAT)可以检测出血清学无法识别的早期病毒血症,从而加强血液安全。目的:通过联合NAT和血清学,量化献血者在11年期间的HCV NAT产量(NAT反应性献血者无反应性抗HCV血清学,与窗口期检测一致)。材料和方法:横断面观察性研究,包括CMN Siglo XXI血库记录的568,569例献血者(2014-2025)。根据NOM-253-SSA1-2012对NAT和血清学结果进行分析,以确定具有NAT反应/血清学无反应模式的献血者。结果:发现1例nat反应/血清学无反应病例,符合窗口期感染。NAT收益率为每10万次捐赠0.18次(每100万次捐赠1.8次)。没有危险因素或合并感染的报告,表明单独的血清学可能会遗漏感染。由于11年来仅记录了一例病例,因此不支持人口水平推断和流行病学影响估计。结论:在一个非常低频率设置的大队列中,NAT识别出血清学未检测到的潜在传染性捐献。虽然绝对产量很低,但每个检测到的病例都与输血安全有关。建议扩大NAT覆盖范围和加强自愿捐赠,以优化墨西哥的输血安全。