| Objective:To investigate mycobacterium tuberculosis and related indicators, the peripheral blood and sputum specimens extracted from clinical-diagnosed TB cases were simultaneously detected by Tuberculosis Interferon Gamma Release Assays(TB- IGRA), the Tuberculin Skin Test(TST), sputum smear and bacteria culture, tuberculosis antibody detection, Lactate Dehydrogenase(LDH), Adenosine Deaminase(ADA), hypersensitive c-reactive protein(hs-CRP) and erythrocyte sedimentation rate(ESR). The results were analyzed to evaluate the meaning of TB-IGRA in the clinical diagnosis and treatment of tuberculosis.Methods:1 Research SubjectsSamples were from 135 cases(78 cases of male, female 57 cases; average age of 35.12 士 15. 33) of patients with TB(including the hospitalized and the clinic) in Baoding Municipal Infectious Diseases Hospital during the period from Nov. 2013 to Oct. 2014. All the cases of treatment time were less than 1 week, and confirmed by clinical or bacteriology examination including 102 cases pulmonary tuberculosis and 33 cases of extrapulmonary tuberculosis. Non-tuberculosis group was consisted of 57 patients diagnosed other infectious diseases from in-patient and outpatient department,contained 32 male cases and 25 female cases(average age 37.12 士 18. 21). The control group was comprised of 40 healthy physical cases, including 22 male cases and 18 female cases with the average age of 29. 01 士 13. 54.2 Testing MethodsAll the samples were examined by TB-IGRA, TST, sputum smear, bacteria culture, tuberculosis antibody detection, LDH, ADA, hs- CRP and ESR test. TB- IGRA was tested by enzyme-linked immune(ELISA) method; TST was tested by Mantoux method; Bacterial culture was tested by Versa TREK rapid liquid culture method; tuberculosis antibody was tested by protein chip method; LDH, ADA was tested by rate method; The hs-CRP was tested by end-point method; The ESR was tested by Westergren method. All the testing items were performed strictly in accordance with the Reagent testing instructions. All the results were analyzed by SPSS17.0.Results:1 The TB- IGRA positive rate of the tuberculous group, non-tuberculous group and control group were 91.9%, 5.2% and 5.0%,respectively. The TB- IGRA positive rate of the tuberculous group was significantly higher than that of non-tuberculosis disease group and control group(χ2=171.861, P< 0.01); However, the TB- IGRA positive rate was no statistically significant between non-tuberculosis group and control group.(χ2= 0.454, P > 0.05)(Table 1).2 The positive detection rate of TB-IGRA was significantly higher than TST test, sputum smear,bacteria culture and tuberculosis antibody detection in Tuberculosis group(χ2 = 137.278, P< 0.01).It was indicated that TB- IGRA in the tuberculosis group was more sensitive than that of several other TB diagnostic test; TB- IGRA positive rate of extrapulmonary tuberculosis group was significantly higher than that of TST test, sputum smear and bacteria culture, tuberculosis antibody detection,(χ2 = 84.545, P<0.01), It was indicated that the TB- IGRA was also sensitive than that of several other TB diagnostic test in extrapulmonary tuberculosis group; The positive rate of TB-IGRA was no statistical significance between tuberculosis and extrapulmonary tuberculosis group(χ2 = 0.052, P> 0.05). It showed that the TB- IGRA in tuberculosis and extrapulmonary tuberculosis had a high diagnostic value(Table 2).3 TB- IGRA test sensitivity was significantly higher than that of TST, sputum smear, germiculture and tuberculosis antibody(χ2 = 212.080, P< 0.01); TB- IGRA test and TST, tuberculosis antibody had no statistical significance(χ2 = 5.337, P> 0.05) in specificity. The positive predictive value of TB- IGRA test was statistically significant difference with that of TST, tuberculosis antibody assay(χ2 = 13.237, P < 0.05). The negative predictive value of TB- IGRA test was statistically significant difference with TST, sputum smear and bacteria culture, tuberculosis antibody(χ2 = 50.996, P < 0.01). TB- IGRA test and TST, tuberculosis antibody had no statistical significance(χ2 = 5.337, P > 0.05) in false-positive rate. The false negative rate of TB- IGRA test was statistically significant difference with that of TST, sputum smear and bacteria culture, tuberculosis antibody(χ2= 212.080, P < 0.01). Youden index of TB- IGRA test was 86.9, higher than that of TST, sputum smear and bacteria culture, tuberculosis antibody, suggested that TB- IGRA test accuracy is more reliable than other methods(Table 3).4 Positive rate of TB- IGRA test was 92.0% for Sputum smear-positive cases,and 91.8% for Sputum smear negative cases, with no statistically significant difference(χ2 = 0.001, P > 0.05). It showed that TB- IGRA test in the sputum smear negative TB patients had a high sensitivity(Table 4).5 The amount of LDH in TB- IGRA positive group was significantly higher than that in TB- IGRA negative groups(t = 2.028, P < 0.05). The amount of ADA in TB- IGRA positive group was significantly higher than that in negative group(t = 2.323, P < 0.05). Hs- CRP in TB- IGRA positive group was significantly higher than that in negative group(t = 3.211, P < 0.01). ESR in TB-IGRA positive group was significantly higher than that in negative group(t = 2.547, P < 0.01)(Table 5).Conclusions:1 The TB-IGRA positive rate of tuberculosis group is significantly higher than that of non-tuberculosis disease group and control group.2 The sensitivity and accuracy of TB-IGRA is significantly higher than that of TST, sputum smear, germiculture and tuberculosis antibody.3 TB- IGRA is a reliable index for judging whether infected with TB and may effectively enhance the accuracy in tuberculosis diagnosis combined with other laboratory assay. |
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