Longitudinal studies regarding the reproducibility of Interferon-gamma release assay (IGRA) T-SPOT.TB for the diagnosis of Mycobacterium tuberculosis (M. tb) infection in serial testing are limited. We retrospectively analysed results of serially tested subjects in a medical laboratory in Germany over a time period of 14 years. From October 2004 to December 2018, a total of 5440 subjects were identified with a second T-SPOT.TB test after a median time interval of 258 days (interquartile range [IQR] 62–665). Consistently negative (n = 4520) or positive results (n = 682) were observed in 5202 (95.6%) subjects, indicating a high degree of concordance in serial testing (κ = 0.83). Test conversions occurred in 101 of 4621 (2.2%) subjects with initially negative tests. Of 819 subjects with initially positive test results, 137 (16.7%) had a test reversion which was associated with low spot numbers of the first test. Of 529 subjects retested within 1 year, only 60 (11.3%) displayed a test reversion. In subjects retested after more than 1 year, 77 of 290 (26.6%) tests reverted. This significantly higher rate of test reversions after more than 1 year was age-dependent and only observed in subjects above the age of 40 years. In the medical laboratory, the T-SPOT.TB test demonstrates a high reproducibility in serial testing.

关于干扰素-γ释放测定（IGRA）T-SPOT的可重复性的纵向研究。TB为诊断结核分枝杆菌（结核分枝杆菌）感染的串行测试是有限的。我们回顾性分析了德国医学实验室历时14年的连续测试受试者的结果。从2004年10月到2018年12月，共有5440名受试者被确定为第二次T-SPOT。中位时间间隔为258天（四分位间距[IQR] 62-665）后进行TB测试。 在5202名（95.6％）受试者中观察到始终为阴性（n  = 4520）或阳性结果（n = 682），这表明在系列测试中高度一致（κ = 0.83）。测试转换发生在4621位（101％）受试者中的101位最初为阴性测试。在819名最初测试结果呈阳性的受试者中，有137名（16.7％）的测试回复与第一次测试的低点数相关。在1年内重新测试的529位受试者中，只有60位（11.3％）表现出测试反转。在超过一年后重新测试的受试者中，290个测试中有77个（26.6％）恢复了测试。超过1年的测试复归率明显更高，这取决于年龄，并且仅在40岁以上的受试者中观察到。在医学实验室，是T-SPOT。TB测试证明了串行测试的高度可重复性。