| Tuberculosis (TB) is an ancient infectious disease, which is wides-pread in the world and seriously affects the health of the human body. The early, rapid and accurate diagnosis of TB is essential in the TB prevention and treatment. Currently, there are three types of laboratory diagnostic methods of TB, which are through the test of bacteriology, serology or molecular biology. Serological testing has been widely used in clinical practice of primary hospitals because of its simple, economic and no requirement of precise instruments. However, there are still some problems, such as the lacking of high titers of specific antigen, the low sensitivity of TB-specific antigen detection, each antigen can only be detected in part of the infected person, the serological diagnosis effect with a single antigen is not ideal. Those are the factors which make the sensitivity and specificity of serological diagnosis unable to meet the requirements of the clinical diagnosis. Therefore, the associated antigen protein fusion expression, or a combination of several antigens has become the research directions of TB serological diagnosis in the future.In this study, a total of81patients with TB diagnosis have been collected in the309th Hospital of Chinese People’s Liberation Army from October2011to May2012. Among them,53cases were male and28female, with the age range from16to84years old. The average age is (43±12) years old. Eleven cases of sputum positive patients, and70cases with sputum negative. The serum from74non-TB patients which has been diagnosed with respiratory diseases, such as pneumonia, emphysema, lung cancer or other lung disease, are from patients hospitalized by the Respiratory Department during the same period in the309th Hospital of Chinese People’s Liberation Army. Among them,39cases were male and35female, with the age range from17to82years old. The average age is (38±21) years old. The serums from30healthy persons are from the Health Examination Center of the309th Hospital of Chinese People’s Liberation Army. Among them,18cases were male and12female, with the age range from18to72years old. The average age is (38±17) years old. The serums from185patients are divided into the following three groups, TB group, non-TB respiratory diseases group, healthy control group. Chemiluminescence immunoassay (CLEIA) is used in the detection of antibody expression level of anti-Rv2041c, Rv1419,38kD-Rv0577-Rv1271c and Rv0057-Rv1352in the serum of the patients. And the clinical application value of these four antigens of serological diagnosis in TB has been analyzed and evaluated statistically. In the TB group, the antibody expression level of anti-Rv2041c, Rv1419,38kD-Rv0577-Rv1271c and Rv0057-Rv1352are (152634.0±24942.8,191623.81±28683.2,115100.9±9255.2,190269.3±20944.2), respectively, which are obviously higher than the non-TB respiratory diseases group, which are (38417.5±4371.8,31166.27±4314.9,27506.7±2604.5.8,45622.3±7083.6), and the healthy control group, which are (36382.9±7774.2,24766.5±4595.7,24280.4±4106.7,36389.9±5000.7, P<0.01). However, there is no significant difference in the antibody expression level between the non-TB respiratory diseases group and the healthy control group (P>0.05). The sensitivity of TB detection with anti-Rv2041c, Rv1419,38kD-Rv0577-Rv1271c, and Rv0057-Rv1352are70.4%,74.1%,75.3%, and67.9%, respectively, which are obviously higher than the sputum smear and culture (13.6%), TB antibody test kit made in Korea (19.8%), and test kit made in Beijing Modern Gaoda Company (24.7%, P<0.01). There is no significant difference compared to the TB antibody test kit made in the Shanghai Upper Bio-Tech Pharmaceutical Co. Ltd (75.3%, P>0.05). The specificity of TB diagnosis are86.5%,83.7%,86.5%, and87.5%, respectively, which are obviously higher than the test kit made in the Shanghai Upper Bio-Tech Pharmaceutical Co. Ltd (62.2%, P<0.05). Compared with the test kit made in Korea (90.5%), there is no obvious difference in the test kit made in Beijing Modern Gaoda Company (85.1%, P>0.05). The combination of any two antigens among these four antigens can be a desirable combination with the sensitivity between77.7%and85.2%, and the specificity between87.5%and90.4%. Results mentioned above showed that all of the recombinant Rv2041c, Rv1419,38kD-Rv0577-Rv1271c, and Rv0057-Rvl352protein of mycobacterium tuberculosis have good antigenic factors and can be used in the TB antibody detection with high sensitivity and specificity. Their combination can increase the detection sensitivity without significantly reducing the detection specificity. These four antigens may become the candidate antigen for serological diagnosis of TB. |
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