Prevalence and influencing factors of the high nil-control spot count in T-SPOT.TB: A matched case-control study

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.