Román-Montes Carla M, Tamez-Torres Karla M, Guaracha-Basañez Guillermo A, Ordinola-Navarro Alberto, Ortiz-Bustamante Marco Antonio, Rajme-López Sandra, Martínez-Guerra Bernardo A, Ordaz-Vázquez Anabel, Sifuentes-Osornio José, Ponce-de-León Alfredo, González-Lara Fernanda, Bobadilla-Del-Valle Miriam
Infectious Diseases Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Immunology and Rheumatology Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
PLoS One. 2025 Jul 21;20(7):e0326615. doi: 10.1371/journal.pone.0326615. eCollection 2025.
Indeterminate QuantiFERON (QFT) results challenge clinical decision-making and often necessitate repeat testing. This study aimed to assess the prevalence of indeterminate QFT results and identify associated factors.
We compared patients with indeterminate QFT results to a 1:1 randomly selected sample of patients with determinate results from a tertiary care center in Mexico City between March 2020 and December 2022.
Among 4,557 QFT®-Plus tests performed during the study period, 10% yielded indeterminate results. A total of 352 cases with indeterminate results and 352 with determinate results were analyzed. In 96% of cases, indeterminate results were attributed to a low mitogen response. No significant differences were observed in age, sex, or comorbidities between groups. Multiple regression analysis identified the following factors as significantly associated with an indeterminate QFT®-Plus result: severe COVID-19 (OR 3.9, 95% CI 2.5-6.2, p < 0.001), pharmacological immunosuppression (OR 1.7, 95% CI 1.2-2.4, p = 0.004), severe lymphopenia (OR 1.7, 95% CI 1.1-2.7, p = 0.02), anemia (OR 1.9, 95% CI 1.3-2.8, p = 0.001) and hospitalization (non-COVID-19) (OR 3.9, 95% CI 2.6-5.9, p < 0.001).
The prevalence of indeterminate QFT®-Plus test results was 10%, which is significant, particularly among patients with COVID-19. Indeterminate results were linked to immunosuppression and markers of disease severity. These findings suggest that it may be advisable to postpone QFT®-Plus testing until the clinical condition of patients improves.
不确定的全血γ-干扰素释放试验（QFT）结果给临床决策带来挑战，通常需要重复检测。本研究旨在评估不确定的QFT结果的发生率并确定相关因素。
我们将QFT结果不确定的患者与2020年3月至2022年12月期间从墨西哥城一家三级医疗中心随机抽取的1:1的QFT结果确定的患者样本进行比较。
在研究期间进行的4557次QFT®-Plus检测中，10%的结果不确定。共分析了352例结果不确定的病例和352例结果确定的病例。在96%的病例中，不确定结果归因于低丝裂原反应。两组在年龄、性别或合并症方面未观察到显著差异。多元回归分析确定以下因素与QFT®-Plus结果不确定显著相关：重症新型冠状病毒肺炎（COVID-19）（比值比[OR]3.9，95%置信区间[CI]2.5-6.2，p<0.001）、药物性免疫抑制（OR 1.7，95%CI 1.2-2.4，p=0.004）、严重淋巴细胞减少（OR 1.7，95%CI 1.1-2.7，p=0.02）、贫血（OR 1.9，95%CI 1.3-2.8，p=0.001）和住院（非COVID-19）（OR 3.9，95%CI 2.6-5.9，p<0.001）。
QFT®-Plus检测结果不确定的发生率为10%，这一比例较高，尤其是在COVID-19患者中。不确定结果与免疫抑制和疾病严重程度标志物有关。这些发现表明，可能建议推迟QFT®-Plus检测，直到患者的临床状况改善。
