Abstract

ObjectiveTo evaluate a biochip system in determining isoniazid and rifampicin resistances of Mycobacterium tuberculosis in sputum samples in a Chinese population.MethodsWe assembled 907 sputum smeared positive specimens of tuberculosis patients in total. Each sample would be separated into two parts for culture and biochip assay simultaneously. And those cultured positive and having full drug resistance results would be used as reference. The McNemar χ2 test was adopted for evaluating the paired 2×2 table.ResultsCompared with drug sensitivity test, the agreement rates of the two methods in detecting rifampicin and isoniazid resistances were 93.37% and 94.49%, respectively. The sensitivity and specificity of biochip in detecting isoniazid were 74.31% and 96.92%, respectively. Meanwhile, the sensitivity and specificity for rifampicin were 79.76% and 96.53%, respectively. For multi-drug resistance, the sensitivity and specificity were 64.62% and 97.75%, respectively.ConclusionsThe biochip system is a rapid and accurate method for drug resistant tuberculosis diagnosis using sputum samples directly, especially for rifampicin resistance detection.

Highlights

  • Tuberculosis (TB) as an infectious disease causes millions of death every year in the world, and it remains a major public health burden in developing countries [1,2]

  • It was in dilemma for TB treatment due to the increasing emergence of drug resistance of Mycobacterium tuberculosis (MTB) complex, which resulted in longer treatment duration but poor prognosis [3,4,5,6]

  • In most countries, there was only less than 5% of the new and previously treated TB patients tested for multidrug resistance (MDR), and the number of MDR cases found only accounted for 16% of the total MDR TB estimated in 2010 [2]

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Summary

Introduction

Tuberculosis (TB) as an infectious disease causes millions of death every year in the world, and it remains a major public health burden in developing countries [1,2]. China holds the second largest number of TB cases in the world and it was estimated that around 1 million new incident TB cases were emerging each year [2]. Recent years, it was in dilemma for TB treatment due to the increasing emergence of drug resistance of Mycobacterium tuberculosis (MTB) complex, which resulted in longer treatment duration but poor prognosis [3,4,5,6]. Diagnosis of MDR TB in China mainly depends on the conventional drug susceptibility test (DST), a complex and fragile method, usually needs several weeks to complete from a primary specimen and requires proficient technicians to interpret the results [8,9]

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