分析了解γ-干扰素释放试验中QuantiFERON-TB gold In-Tube (QFT-GIT)检测可疑结核感染患者结核分枝杆菌(Mycobacterium tuberculosis，MTB)不确定结果(indeterminate test results, ITRs)的分布情况，为制定改进QFT-GIT检测MTB结果准确率的措施，提供客观依据。

回顾性分析2015年1月至2016年6月期间,从山东省104家医院收集的4854份可疑结核感染患者标本在济南金域医学检验中心用QFT-GIT检测MTB的结果，比较不同级别医院、不同性别、7个不同年龄组ITRs发生率和分布情况，并回访分析产生ITRS的原因。

用QFT-GIT检测4854份可疑结核感染患者标本,ITRs总发生率为6.55%(318/4854)。其中：一级医院为24.53%(13/53)，二级医院为6.25%(52/832)，三级医院为6.37%(253/3969)，经一级医院与二级医院和三级医院间的ITRs发生率两两比较，差异有统计学意义(χ²分别为24.462、27.908，P均<0.001)，二级医院ITRs发生率与三级医院比较，差异无统计学意义(χ²=0.018，P>0.05)。女性可疑结核感染患者标本的ITRs发生率为6.09%(117/1921份)，男性为6.85%(201/ 2933份)，不同性别组标本的ITRs发生率差异无统计学意义(χ²=2.135，P>0.05)。≥76岁组ITRS发生率最高[9.39%(63/671)]，且与16~30岁组[3.43%(23/670)]、31~45岁组[5.91%(46/779)]、46~60岁组[6.13%(75/1224)]比较，差异均有统计学意义(χ²值分别为19.816、6.294、6.828；P值分别为0.000、0.012、0.009)。6~15岁组[7.89%(9/114)]与16~30岁组比较，差异亦有统计学意义(χ²=为4.954，P<0.05)，16~30岁组与61~75岁组[7.24%(98/1353)]比较，差异有统计学意义(χ²=11.569，P<0.001)。回访194例可疑结核感染患者ITRs的发生原因，确定83例患者发生ITRs的原因为，服用大剂量激素类和免疫抑制剂药物治疗期间采集标本患者36例，常规检测淋巴细胞偏低25例，严重炎症如重症肺炎、肺脓肿等22例; 3种原因在三级医院的分布顺序为药物、淋巴细胞偏低、严重炎症，二级医院为淋巴细胞偏低、药物、严重炎症，一级医院为严重炎症、淋巴细胞偏低。

QFT-GIT检测可疑结核感染患者MTB感染的ITRs发生率一级医院与二级和三级医院的差异可能与不同级别医院患者疾病种类、治疗状况不同有关，三级医院主要原因为服用免疫抑制剂和激素类药物为主，二级医院以为淋巴细胞偏低为主，一级医院造成不确定原因可能以严重炎症为主，也可能同时与不同级别医院对标本分析前质量控制程度不同有关。ITRs发生率在不同性别人群中无差异，≥76岁组ITRs发生率最高，依次为6-15岁组、61~75岁组、46-60岁组、31-45岁组、16-30岁组，年龄因素是造成ITRs发生的重要影响因素。

Analyze the indeterminate test results(ITRs) distribution in the detection of Quanti-FERON-TB Gold In-Tube (QFT-GIT), a kind of interferon gamma release test, within patients suspected with tuberculosis infection.

Four thousand eight hundred and fifty-four blood samples from patients speculated with tuberculosis infection were collected from 104 hospitals in different regions of Shandong province from January 2015 to June 2016, all samples were detected with QFT-GIT in Ji′nan Jinyu medical examination center. A retrospective study was performed to analyze the incidence and distribution of ITR in gender, ages and levels of hospitals, and to explore the causes of ITRS by reviewing the data in a comprehensive way.

QFT-GIT was used to detect 4854 cases of suspected tuberculosis infection. The incidence of ITRs was 6.55% (318/4854) in all blood samples, including: 24.53% (13/53) in first grade hospital, 6.25% (52/832) in second grade hospitals and 6.37% (253/3969) in the third grade hospitals. There was a significant difference in the incidence of ITRs between the first and two grade hospitals and the level three hospitals, compared with the level of(χ² were respectively 24.462, 27.908, P<0.001). There was no significant difference in the incidence of ITRs between the two hospitals and the grade three hospitals(χ²=0.018, P>0.05). the incidence of ITR was 6.09% (117/1921) in female was, and 6.85%(201/2933) in male, which showed no significant difference (χ²=2.135, P>0.05). More than 76 years old was the highest incidence of ITRS[9.39% (63/671)], and the 16-30 years group[3.43%(23/670)], 31-45 years group[5.91%(46/779)], 46-60 years group [6.13%(75/1124)]differences were statistically significant (χ² were 19.816, 6.294, 6.828; and P=0.001, 0.012, 0.009). There was significant difference between 6-15 years old group [7.89%(9/114)]and 16-30 years old group (χ²=4.954, P<0.05), there was significant difference between 16-30 years old group and 61-75 years old group[7.24%(98/1353), χ²=11.569, P<0.001]. Eighty-three from 194 cases of ITR could be attribute to the use of large dose of immunosuppressant drugs and predison (36) accounting for 43.37%, severe inflammation (22), accounting for 26.50%, and in, revealing that the clinical detection of this project causes the occurrence of ITRs, immunosuppressive drugs, lymphocyte is abnormal and inflammatory diseases are the dominant factors lead to this result.

The difference in patients infected with MTB ITRs QFT-GIT to detect suspicious tuberculosis infection in a hospital and two hospital three hospitals may be different with different level of hospital patients with different diseases, treatment status, level three the main reason for immunosuppression and hormone drugs, two hospitals that low level lymphocytes mainly caused by hospital not likely to determine the cause of serious inflammation, may also by different levels of hospital quality control analysis of the influence of different degree of specimen. The incidence of ITRs in different gender groups there were no differences. In the age group over 76 years, ITRs group was the highest, and the 6-15 years old group, 61-75 years group, 46-60 years group, 31-45 years group, 16-30 years group. There was significant difference between and 16-30 years old group, and age factor was an important factor of ITRs.