Ruedas-López Alba, Herrero-Martínez Juan María, Reyes Alhena, González-Blanco Beatriz, López-Roa Paula
Clinical Microbiology and Parasitology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Department of Preventive Medicine, Public Health and Microbiology, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
PLoS One. 2025 Sep 8;20(9):e0330345. doi: 10.1371/journal.pone.0330345. eCollection 2025.
The Quantiferon Gold Plus (QFT) test, a widely used interferon-γ release assay (IGRA), diagnoses latent tuberculosis infection (LTBI) with a positivity threshold of ≥0.35 IU/mL. Results near this cut-off can be challenging to interpret due to variability from immunological, pre-analytical, and technical factors, prompting recommendations for a borderline range to refine diagnosis and reduce overtreatment. This retrospective study analyzed QFT results from 9,944 patients (2019-2023), establishing ranges: < 0.2 IU/mL as negative, 0.2-0.35 IU/mL as borderline negative, 0.35-0.7 IU/mL as borderline positive, and >0.7 IU/mL as positive. Borderline results occurred in 7.6% of patients, particularly in those born in Africa or South America, and in older individuals. Of 64 patients retested, 60.9% reverted to negative, while 17.1% of borderline negatives later converted to positive or borderline positive. Notably, no active TB cases emerged among those who reverted to negative on repeat testing. These findings emphasize the need for cautious interpretation of borderline QFT results, as their link to active TB progression differs from clear results. The study supports repeat testing of borderline cases to enhance LTBI diagnostic accuracy and inform treatment decisions.
结核感染T细胞检测金标增强版(QFT)试验是一种广泛应用的干扰素-γ释放试验(IGRA),用于诊断潜伏性结核感染(LTBI),阳性阈值为≥0.35 IU/mL。由于免疫、分析前和技术因素的变异性,接近该临界值的结果可能难以解释,因此有人建议设定一个临界范围以优化诊断并减少过度治疗。这项回顾性研究分析了9944例患者(2019 - 2023年)的QFT结果,确定了以下范围:<0.2 IU/mL为阴性,0.2 - 0.35 IU/mL为临界阴性,0.35 - 0.7 IU/mL为临界阳性,>0.7 IU/mL为阳性。临界结果出现在7.6%的患者中,特别是那些出生在非洲或南美洲的患者以及老年患者。在64例重新检测的患者中,60.9%的结果恢复为阴性,而17.1%的临界阴性患者后来转为阳性或临界阳性。值得注意的是,在重复检测中恢复为阴性的患者中没有出现活动性结核病例。这些发现强调了对临界QFT结果进行谨慎解释的必要性,因为它们与活动性结核进展的关联与明确结果不同。该研究支持对临界病例进行重复检测,以提高LTBI诊断准确性并为治疗决策提供依据。