Serological Evaluate Using Recombinant 16kDa-38kDa-ESAT-6 Protein Of Mycobacterium Tuberculosis

ObjectiveTB is Mycobacterium tuberculosis (Mycobacterituberculosis, Mtb) caused by chronic infectious diseases, Each year more than 900 million new cases, about two million deaths. So far about 20 million people are infected,Tuberculosis has become a serious global public health and social problems, the current gold standard for diagnosis of tuberculosis is smear or culture diagnosis. However, lower smear-positive rate and long culture time Can not meet the clinical needs. Serological testing for its simple, fast, accurate and received extensive attention. How to find the ideal target antigen has been the focus of many academic research. Recent studies show that only a single antigen sensitivity of serological diagnosis of TB is often not enough. At present, the TB recombinant protein 16Kda-38kda improve the specificity and the sensitivity of serological diagnosis of tuberculosis have proved by foreign scholars. But our country 16Kda-38kda recombinant fusion protein was little research. The purpose of this study is use of 16Kda-38kda-ESAT-6 recombinant protein of Mycobacterium tuberculosis for the coated antigen to detection of serum TB, gain serological evaluate about antigen in the diagnosis of tuberculosis, and comparate to the commercial kit,To assess the value of the antigen for diagnosis of tuberculosis in serodiagnosis..For the further development of diagnostic kits to provide the basis.MethodsELISA was used for the detection of Recombinant 16kDa-38kDa-ESAT-6 Protein of all cases as coated antigen in serum of 150 patients, Humoral immune response was analysed in a group of 105 TB patients (26smear-positive,79 smear-negative), and in control groups consisting of 20 healthy volunteers and 25 subjects with pulmonary diseases other than TB(NTB). Compared the positive rates and OD value and sensiti- vity,specificity,positive predictive value and negative predictive value,reen the sera of tuberculosis(TB) patients (n=105),healthy controls(n=20) and non-tuberculosis(NTB) patients (n=25) by ELISA,compared with TB-DOT to evaluate the value of the recombinant 16kDa-38kDa-ESAT-6 Protein. Assess the value of the antigen for diagnosis of tuberculosis in serodiagnosis,and establish a ROC evaluation systemResultIn control groups, the positive rates of anti-the recombinant 16kDa-38kDa-ESAT-6 Proteinis and Commercialization of Tuberculosis Antibody Test Kit had statistical significant difference (P<0.01);but in TB patients, which hadn't statistical significant difference (P>0.05); The OD value of TB and control groups is 2.22±0.58,1.35±0.24 respectively,the OD value of two groups had statistical significant difference(F=6.06,P<0.01); The sensitivity, specifity, positive predictive value and negative predictive value of the test were determined at 59.05%,93.33%,95.38%,49.41%, respectively. Application of ROC curves, the area under the curve for 0.751,the value of cutoff 2.52, sensitive and specific were 65.4% and 84.8%,respectively.ConculutionRecombinant 16kDa-38kDa-ESAT-6 Protein of Mycobacterium Tuberculosis with higher sensitivity and specificity,there was significantly distinction between TB patients and non-TB patients. So Recombinant 16kDa-38kDa-ESAT-6 Protein had an important value in diagnosis of tuberculosis,and it might be selected as one of diagnosis antigens of tuberculosis.