Abstract

BackgroundThis study aimed to establish and evaluate a simultaneous amplification and testing method for detection of extra-pulmonary tuberculosis (EPTB).MethodsFrom January 2016 and December 2017 the pus or surgical excision from the lesions of inpatients admitted from Chongqing Public Health Treatment Center were collected. According to the clinical diagnosis, the samples were divided into two groups including EPTB (Group A) and other diseases excluded from tuberculosis diseases (Group B). Simultaneous detection of Mycobacterium tuberculosis (MTB) used Roche culture method, liquid culture method and simultaneous amplification and testing (SAT) method. The sensitivity and specificity of the SAT method were compared with culture methods and clinical diagnosis of EPTB.ResultsFor 433 EPTB specimens and 49 non-TB specimens, the simultaneous amplification and testing tuberculosis (SAT-TB) results correlated with 80.5% (388/482 specimens) of the culture assay results. The sensitivity, specificity, and positive and negative predictive values of the SAT-TB test for the diagnosis of EPTB were 83.6, 79.4, 59.4, and 93.0%, respectively, compared to culture methods. Compared with the clinical diagnosis of patients, the sensitivity and specificity of the SAT-TB test were 41.6 and 100%, respectively, the cultures test were 29.3 and 98.0%.ConclusionsSAT test is a simple and rapid test with high specificity which may enhance the detection of EPTB. SAT-TB is a higher clinical diagnosis value for EPTB in clinical microbiology laboratories.

Highlights

  • This study aimed to establish and evaluate a simultaneous amplification and testing method for detection of extra-pulmonary tuberculosis (EPTB)

  • This study aimed to evaluate the clinical accuracy of Simultaneous Amplification and Testing (SAT) in the diagnosis of EPTB by comparing sensitivity, specificity, positive predictive value and negative predictive value of both SAT and culture methods in detecting EPTB specimens

  • Comparison of tuberculosis simultaneous amplification and testing (TB-SAT) and culture methods Four hundred eighty-two extra-pulmonary tuberculosis specimens tested by the TB-SAT and culture methods

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Summary

Introduction

This study aimed to establish and evaluate a simultaneous amplification and testing method for detection of extra-pulmonary tuberculosis (EPTB). Tuberculosis (TB) is a chronic infectious disease that endangers human health for a long time. Rapid and accurate laboratory testing technology plays an important role in assisting the early diagnosis of EPTB in clinical practice. Simultaneous Amplification and Testing (SAT) is one of the molecular biological detection methods used by the tuberculosis laboratory in China in recent years. SAT has rarely been used to test EPTB specimens and its sensitivity and specificity for EPTB diagnosis are still not clear. This study aimed to evaluate the clinical accuracy of SAT in the diagnosis of EPTB by comparing sensitivity, specificity, positive predictive value and negative predictive value of both SAT and culture methods in detecting EPTB specimens

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