聚合酶链反应—微孔板杂交法检测结核杆菌的临床应用及其评价

Clinical application and evaluation of polymerase chain reaction-microwell plate hybridization assay in the detection of Mycobacterium tuberculosis]

OBJECTIVE: To evaluate the clinical application and feasibility of polymerase chain reaction-microwell plate hybridization assay in the detection of Mycobacterium tuberculosis. METHODS: 1130 specimens with strong suspicion for mycobacterium tuberculosis were collected from the hospitals and were detected by fast bacilli stain, culture, PCR-electrophoresis and PCR-microwell plate hybridization respectively. The laboratory results were analyzed in combination with the symptoms and signs of patients and the observations on treatment. Also detected were 100 samples from the clinically evidenced non-tuberculosis patients. RESULTS: In the 100 samples collected from the patients without tuberculosis, the PCR-hybridization method and culture method did not detect Mycobacterium tuberculosis, but the fast bacilli stain method and PCR-electrophoresis method brought out one and two false-positive results respectively. The results of testing the 1030 clinical samples which probably contained Mycobacterium tuberculosis demonstrated that the PCR-hybridization method had the highest positive rate (481/1030) among the four methods, and the positive rates of the other three methods were PCR-electrophoresis (406/1030), culture (365/1030) and fast bacilli stain (256/1030) in proper order. The chi-square test showed that there were significant difference between the PCR-hybridization method and the other three methods respectively (P < 0.0083 or P < 0.0017). CONCLUSION: PCR-Hybridization method is specific, sensitive, accurate and fast in detecting mycobacterium tuberculosis; it is worthy to be used clinically.