Clinical diagnostic value of simultaneous amplification and testing for the diagnosis of sputum-scarce pulmonary tuberculosis

Abstract

BackgroundSince 20% of pulmonary tuberculosis (PTB) patients are asymptomatic, the early detection of PTB is a challenge particularly in sputum-scarce patients and diagnostic accuracy based solely on clinical characteristics and chest X-ray/CT scans are not always satisfactory. The AmpSure simultaneous amplification and testing method for the detection of Mycobacterium tuberculosis (SAT-TB assay) is an alternative approach to diagnose PTB. In the present study, we analyzed the usefulness of the SAT-TB assay for PTB diagnosis in sputum-scarce patients.MethodsA total of 840 patients were prospectively enrolled for PTB diagnosis with bronchial alveolar lavage fluid (BALF) used as the samples for the SAT-TB assay. Of these, 536 had a definite diagnosis of PTB confirmed by positive microbiology culture, or clinical diagnosis of active PTB following anti-TB treatment with a favorable response.ResultsThe SAT-TB assay showed a 76.44% agreement with the culture test. The sensitivity and specificity of the SAT-TB assay were 50.75% and 94.73%, respectively. The sensitivity of SAT-TB was significantly higher than that of BALF cultures (21.64%) (X2 = 49.1503; P < 0.001) and smears (4.48%) (X2 = 175.2315; P < 0.001). The specificity of SAT-TB was slightly lower than that of BALF cultures (98.25%) (X2 = 2.0727; P = 0.150) and smears (98.25%) (X2 = 2.0727; P = 0.150). The accuracy rates were 63.87% for SAT-TB, 44.50% for BALF cultures and 29.84% for BALF smears.ConclusionThe high accuracy of the SAT-TB assay indicated that active PTB is present and anti-TB treatment is strongly recommended regardless of smear and culture test results for sputum scarce active PTB suspected patients when BALF SAT-TB is positive.

Application of real-time simultaneous amplification and testing method to accurately and rapidly detect extra-pulmonary tuberculosis

“…Simultaneous Amplification and Testing (SAT) is one of the molecular biological detection methods used by the tuberculosis laboratory in China in recent years. It is mainly used to detect MTB in sputum to assist diagnosis [4][5][6][7]. However, SAT has rarely been used to test EPTB specimens and therefore, its sensitivity and specificity for EPTB diagnosis are still not clear.…”

Application of Real-Time Simultaneous Amplification and Testing Method to Accurately and Rapidly Detect Extra-pulmonary Tuberculosis

“…Simultaneous Amplification and Testing (SAT) is one of the molecular biological detection methods used by the tuberculosis laboratory in China in recent years. It is mainly used to detect Mycobacterium tuberculosis (MTB) in sputum to assist diagnosis (Cui Z et al 2012;Zhang Q et al 2017;Yan L et al 2017;Chen Y et al 2018). However, SAT has rarely been used to test EPTB specimens and therefore, its sensitivity and specificity for EPTB diagnosis are still not clear.…”

Parallel Tests Using Culture, Xpert MTB/RIF, and SAT-TB in Sputum Plus Bronchial Alveolar Lavage Fluid Significantly Increase Diagnostic Performance of Smear-Negative Pulmonary Tuberculosis

“…Simultaneous amplification and testing method for TB is another fast molecular tool for MTB detection ( Fan et al, 2014 ; Yan et al, 2017 ). Previous studies showed that the specificity of SAT-TB is almost 100% in detecting PTB ( Yan et al, 2016a , b ), suggesting that SAT-TB has potential clinical value in the diagnosis of PTB as novel assay.…”