Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Clinical Epidemiology Unit, International Clinical Epidemiology Network (INCLEN), Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Centre for Tuberculosis Research, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Clin Chim Acta. 2018 Dec;487:96-100. doi: 10.1016/j.cca.2018.09.012. Epub 2018 Sep 7.
T-SPOT.TB may yield indeterminate results, including high nil responses and insufficient mitogen responses. We explored the incidence and risk factors of high nil responses.
A 1:1 matched case-control study of patients who underwent T-SPOT.TB tests in Peking Union Medical College Hospital from Jan 1, 2015 to Apr 30, 2017 was conducted. High nil responses were defined as >10 spots in negative control wells. Cases and controls were matched based on when the tests were performed. Demographic, clinical and laboratory data were obtained from the Medical Record System.
A total of 644 out of 36,316 (1.76%, 95% CI: 1.63%-1.90%) patients presented with high nil responses (280 cases and 280 controls were enrolled). Multivariate analysis revealed that male (OR = 1.882, 95% CI: 1.222-2.899), Behcet's disease (OR = 7.764, 95% CI: 1.714-35.167), heavy use of corticosteroids within a month (OR = 0.357, 95% CI: 0.138-0.921, for >1000 mg group) and hypoalbuminemia (OR = 0.385, 95% CI: 0.241-0.615) are significantly associated with high nil responses.
High nil responses in T-SPOT.TB assays are quite rare. Male gender and Behcet's disease are suggested as independent risk factors, while recent excessive use of corticosteroids and hypoalbuminemia seem to be independent protective factors.
T-SPOT.TB 可能会产生不确定的结果，包括高阴性对照反应和不足的有丝分裂原反应。我们探讨了高阴性对照反应的发生率和危险因素。
我们进行了一项 1:1 病例对照研究，纳入了 2015 年 1 月 1 日至 2017 年 4 月 30 日期间在北京协和医院进行 T-SPOT.TB 检测的患者。高阴性对照反应定义为阴性对照孔中>10 个斑点。病例和对照是根据检测时间进行匹配的。从病历系统中获取人口统计学、临床和实验室数据。
共有 36316 例患者中的 644 例（1.76%，95%CI：1.63%-1.90%）出现高阴性对照反应（纳入 280 例病例和 280 例对照）。多变量分析显示，男性（OR=1.882，95%CI：1.222-2.899）、白塞病（OR=7.764，95%CI：1.714-35.167）、一个月内大剂量使用皮质类固醇（OR=0.357，95%CI：0.138-0.921，>1000mg 组）和低白蛋白血症（OR=0.385，95%CI：0.241-0.615）与高阴性对照反应显著相关。
T-SPOT.TB 检测中高阴性对照反应相当罕见。男性和白塞病被认为是独立的危险因素，而近期大剂量使用皮质类固醇和低白蛋白血症似乎是独立的保护因素。
