关键词: 结核, 抗体, 干扰素γ, 试剂盒, 诊断, 诊断技术和方法, 数据说明, 统计

Abstract:

Objective To explore the value of tuberculosis antibody (TB-Ab) detection and T-SPOT.TB test in TB diagnosis. Methods Between January 1, 2016 and April 12, 2017 in Beijing Geriatric Hospital, 961 TB patients (defined as TB group; including 364 smear positive pulmonary TB cases (bacteriologically diagnosed) and 597 smear negative pulmonary TB cases (clinically diagnosed)) and 1046 non-TB patients (defined as control group) were included in this study. All subjects conducted serological TB-Ab detection by using TB-DOT (Shanghai Upper Bio-Tech Pharma Co., LTD) and ASSURE TB (MP Biomedicals Asia Pacific Pte Ltd. in Singapore) kits; among them, 574 patients in the TB group and 664 patients in the non-TB control group received both T-SPOT.TB test and TB-Ab detections using the two gold standard reagents. The sensitivity and specificity of those three kinds of laboratory detection techniques or joint detection (including tandem detection and parallel detection) were analyzed.Results The sensitivity and specificity of TB-DOT test were 52.86% (508/961) and 74.95% (784/1046), and those of ASSURE TB test were 45.99% (442/961) and 76.00% (795/1046). The sensitivity of TB-DOT and ASSURE TB were 64.84% (236/364) and 62.09% (226/364) for smear positive pulmonary TB patients versus 45.56% (272/597) and 36.18% (216/597) for smear negative pulmonary TB patients, which indicated that the sensitivity of TB-DOT and ASSURE TB was higher for smear positive patients compared with smear negative ones; the differences were statistically significant (χ²=60.99 and 33.69, all P<0.05). Tandem detection of two TB-Ab detections and T-SPOT.TB showed a sensitivity of 24.04% (138/574) and a high specificity of 89.91% (597/664). The parallel detection had a specificity of 21.23% (141/664) and a high sensitivity of 89.55% (514/574). 24.04% (138/574) patients in the TB group and 10.09% (67/664) patients in the non-TB control group reacted positively in all of the three tests including ASSURE TB, TB-DOT and T-SPOT.TB detection, while 10.45% (60/574) cases in the TB group and 21.23% (141/664) cases in the non-TB control group reacted negatively; the differences were statistically significant (χ²=43.37 and 26.32, all P<0.05).Conclusion Tandem of two TB-Ab detections and T-SPOT.TB test can improve the specificity, whereas parallel detection can improve the sensitivity in TB diagnosis. All positive and all negative profile in all of the three detections has an auxiliary value in serological diagnosis of TB.

Key words: Tuberculosis, Antibodies, Interferon-gamma, Reagent kits, diagnostic, Diagnostic techniques and procedures, Data interpretation, statistical