[Incremental cost-effectiveness of the second Xpert MTB/RIF assay for detection of Mycobacterium tuberculosis].

Objective: To study the incremental cost-effectiveness of the second Xpert assay in detection of Mycobacterium tuberculosis (Mtb) and rifampicin (RIF) resistance. Methods: We continuously collected 2 896 specimens from suspected tuberculosis patients who had undergone 2 Xpert tests in a week from March 2015 to March 2018, including 2 402 suspected tuberculosis patients with 1 523 males and 879 females, with an average age of 50 years. Among them, 2 144 specimens of sputum and 258 cases of bronchoalveolar lavage fluid were collected. We also enrolled 494 patients with suspected extrapulmonary tuberculosis, 318 males and 176 females, with an average age of 42 years. Among them, 157 pleural effusion specimens, 106 cerebrospinal fluid specimens, 34 urine specimens and 197 pus specimens were collected. All specimens were subjected to two Xpert tests, smear microscopy, liquid rapid culture (BACTEC MGIT 960), and positively cultured bacteria were tested for drug susceptibility. Results: Among the 2 896 specimens from suspected tuberculosis patients, either one of the two Xpert test results was positive (including both tests were positive, the same below) in 1 639 patients, and 1 502 (91.6%) were positive in the first Xpert tests. The additional 137 (8.4%) test results were positive in the second tests. According to the smear test results, all specimens were divided into the smear negative group and the smear positive group. The second Xpert test was significantly higher than the smear-positive group (14.86%, 3.2%, P< 0.001), and the extrapulmonary tuberculosis group was higher than the tuberculosis group (11.2%, 8.0%, P= 0.12).Of the susceptibility test results, a total of 371 were rifampicin-resistant specimens. The first Xpert detected 91.4% (339/371), and the second Xpert detected the additional 8.1% (30/371).The cost increase of the second test was very significant. Tests were calculated at 650 yuan per time, the tuberculosis group was 1 184 yuan and 13 696 yuan( P< 0.001); the extrapulmonary tuberculosis group was 1 755 yuan and 13 961 yuan( P< 0.001). In the test of specimens of tuberculosis and extrapulmonary tuberculosis, the smear-negative specimen cost increase of the second Xpert test was lower than that of the smear-positive specimen. Conclusion: The second xpert test showed significant value-added cost-effectiveness in the diagnosis of tuberculosis.