A systematic review of rapid diagnostic tests for the detection of tuberculosis infection

Abstract

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Laboratory evaluation of a specimen transport medium for downstream molecular processing of sputum samples to detect Mycobacterium tuberculosis

“…Performance was in line with generally accepted characteristics of molecular testing for M. tuberculosis: 90-100% sensitivity in microscopy smear-positive sputum specimens and 55-75% among smearnegative cases (Armand et al, 2011, Dinnes et al, 2007, Miller et al, 2011, Steingart et al, 2014. There was no apparent effect of chemical composition of PS-MTM on detection of lower bacillary loads as diagnostic performance among smear-negative cases was adequate.We did not test amplification suppression, but think that the effect, if present, was minimal as we were able to successfully amplify M. tuberculosis at relatively low CFU/ml as well as detect smear negative TB cases in the clinical laboratory evaluation.…”

Colorimetric microwell plate reverse-hybridization assay for Mycobacterium tuberculosis detection

“…The most notable advantage of NAA tests is their rapid turnaround time, which may have important implications for patient management and TB control (Dinnes et al 2007). Compared with culture-based methods, NAA tests can detect the presence of M. tuberculosis bacteria in a specimen weeks earlier for 80-90% of patients suspected to have PTB, whose TB will be ultimately confirmed by culture (CDC 2009).…”

“…NAA tests could have the greatest impact in smear-negative disease, as the lower sensitivity makes ruling out disease more difficult. For smear-negative disease, the appropriate use of NAA tests will depend on the associated degree of clinical suspicion (Dinnes et al 2007, CDC 2009.…”

“…The traditional gold standard for diagnosis is the combination of rapid identification of bacilli by direct microscopy with culture for subtype identification. However, given the diagnostic limitations of microscopy and the length of time required for traditional culture methods, attention has been focused on the development and evaluation of rapid methods for the detection of M. tuberculosis (Dinnes et al 2007). To improve the case-detection rate, many new molecular techniques have been developed for TB diagnosis, including commercially available kits and in-house methods.…”

Evaluation of Lionex TB kits and mycobacterial antigens for IgG and IgA detection in cerebrospinal fluid from tuberculosis meningitis patients

“…Ziehl Neelsen acid-fast bacilli (AFB) staining is the most commonly used laboratory method to diagnose TB; however, in extra-pulmonary TB, the sensitivity is too low (10-40%) and culture is more sensitive (50-70%) but time-consuming (Garg 1999, Chandramuki et al 2002, Thwaites et al 2004). Newer diagnostic methods based on nucleic acid amplification tests have been developed, but meta-analysis studies have indicated that despite high specificity, the sensitivity is lower and variable (Pai et al 2003, Dinnes et al 2007. T cell based assays detecting INF-γ production have been reported to be promising; however expense, the requirement of fresh clinical specimens and inadequate laboratory infrastructure limit their use in low-income countries.…”