The Investigation On Aplication Of Phage-based Splitting Assay In Fast Detection For Mycobacterium Tuberculosis

At present, the whole world 1/3 of the population approximately are infectious to Mycobacterium Tuberculosis .One Person is infectious to Mycobacterium Tuberculosis every minute on the everage. Every year 3 million people die of tuberculosis . It is the most infectious disease to life as the unitary germs. It has become a task of diagnosing and curing tuberculosis. Now we still are short of the distinctive , sensitive , speedy laboratory diagnosing method.In recent years as the increase of the knowledge on the function and structure of phage by human. The function of phage is being developed step by step as a kind of studying tool. We have developed phage of Mycobacterium Tuberculosis successfully. On basis of the test of Mycobacterium Tuberculosis we can detect Mycobacterium Tuberculosis using the characteristic of growing fast phage and high specificity. This technology is paid closed attention on the tuberculosis in recent years ,especially the detection rate of tuberculosis in the pleural fluid whose Tuberculosis concentration is lower is more highly. We can offer help with the method of phage-based splitting assay to test the Mycobacterium Tuberculosis in the sputum, pleural fluid, ascitic fluid of the Tuberculosis patient.Objective : To explore the clinical application value of phage-based splitting assay in fast detecting mycobacterium tuberculosis.Method :I have collected 116 samples of Tuberculosis patients who lived in hospital and being diagnosed. (including the sputum/alveolar wash 58, pleural fluid 46, ascitic fluid 12).The samples were detected with phage-based splitting assay , smear method and L-J cultivation.Results: 1,79.3% of samples was positive by phage-based splitting assay ,which was significantly deviated with smear method (31.9%) but not significantly deviated with L-J cultivation (74.1%). The detection rate of phage-based splitting assay is higher to smear method,the contrast has statistical significance. (P<0.05). The detection rate of phage-based splitting assay is nearly to L-J cultivation, the contrast has not statistical significance (P>0.05).2,The positive coincidence is 94.6%,negative coincidence is 27.8%,integer coincidence is 49.1% by phage-based splitting assay with smear method. The positive coincidence is 84.9%,negative coincidence is 36.7%,integer coincidence is 72.4% by phage-based splitting assay with L-J cultivation.Conclusion : 1,the phage-based splitting assay is higher coincidence to L-J cultivation,the detection has not statistical significance.the detection has statistical significance between the phage-based splitting assay with L-J cultivation. This method has higher sensitivity. 2,the time of the phage-based splitting assay is only 18-24 hours which is short in 8 weeks of L-J cultivation. It is important to the rapid diagnosis and early treatment of mycobacterium tuberculosis.3,Phage-based splitting assay is fast,safe and convenient method to detect the viable organism of mycobacterium tuberculosis with high sensitivity and specificity. Its result can be judged easily, it has no special technique request to the operator,it can be extanded at all medical units,especially in basic hospital. It has vast prospect foreground and accord to the clinical requirement.