Tounsi Wajnat A, Hakami Nora Y, Alamoudi Seraj O, Altayeb Wejdan A, Aljuhani Shahad H, Al-Sulami Afnan J, Alzahrani Osama A, Garout Raed M, Almansouri Taghreed S, Bawazir Waleed M, Qattan Aisha, Badawi Maha A
Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah 21589, Saudi Arabia.
Laboratory Department, King Abdulaziz University Hospital, Jeddah 21589, Saudi Arabia.
Diagnostics (Basel). 2025 Sep 7;15(17):2261. doi: 10.3390/diagnostics15172261.
: Grey zone serologic results in blood donor screening pose challenges for transfusion safety, donor management, and blood supply sustainability. In Saudi Arabia, standardized national protocols for managing grey zone outcomes remain lacking. This study aimed to evaluate the prevalence and follow-up outcomes of grey zone serologic results among blood donors at a Saudi hospital over a five-year period. : Serological screening results of six transfusion-transmissible infections (TTIs) markers were extracted alongside nucleic acid testing (NAT) results for HBV, HCV, and HIV. The grey zone was defined as a signal-to-cutoff (S/CO) of 0.90-0.99. Repeat and follow-up results, including subsequent donations, were assessed for seroconversion. : A total of 48,241 donations from 38,524 donors were analyzed. Anti-HBc showed the highest reactivity ( = 2312; 4.8%), followed by HbsAg ( = 2292; 0.31%) and syphilis ( = 218; 0.5%). Grey zone results were rare, and most frequent in anti-HBc ( = 76; 0.16%), HCV ( = 39; 0.08%), and HBsAg ( = 28; 0.06%). Grey zone-to-reactive conversion upon subsequent donation was rare. Three donors who initially tested in the grey zone for anti-HBc later tested reactive in subsequent donations, but their HBV NAT remained negative. : While grey zone outcomes were infrequent, a subset involving HBV markers showed low-level reactivity on repeat testing. For other TTIs markers, grey zone results likely reflected assay variability rather than true infection. We propose a six-month temporary deferral with follow-up serologic and NAT testing, allowing conditional re-entry for donors with consistently non-reactive results, supporting both transfusion safety and a more sustainable donor pool.
在献血者筛查中，灰区血清学结果给输血安全、献血者管理和血液供应可持续性带来了挑战。在沙特阿拉伯，仍缺乏管理灰区结果的标准化国家方案。本研究旨在评估沙特一家医院五年期间献血者中灰区血清学结果的患病率及随访结果。提取六种输血传播感染（TTI）标志物的血清学筛查结果以及乙肝病毒（HBV）、丙肝病毒（HCV）和人类免疫缺陷病毒（HIV）的核酸检测（NAT）结果。灰区定义为信号与临界值（S/CO）为0.90 - 0.99。对重复检测和随访结果（包括后续献血情况）进行血清学转换评估。共分析了来自38524名献血者的48241份献血样本。抗-HBc反应性最高（n = 2312；4.8%），其次是HBsAg（n = 2292；0.31%）和梅毒（n = 218；0.5%）。灰区结果罕见，在抗-HBc中最常见（n = 7
