Molecular Diagnostics

LiquidArray® MTB-XDR VER 1.0

Powered by LiquidArray® | Next generation multiplexing
Next generation multiplexing

LiquidArray® powering detection of second-line drug resistance in tuberculosis

Next generation multiplexing
Detect MTB complex and report up to 28 mutations in fluoroquinolones, linezolid, amikacin and ethambutol resistance-mediating genes
Wealth of information
Sequencing-like results in under 5.5 hours for personalised treatment and for disease surveillance
LiquidArray® technology
Pioneering PCR-based technology enables high level multiplex analysis to provide comprehensive coverage in one well
Results at a glance
Familiar PCR workflow with each resistance-mediating mutation listed in a user-friendly report

Detection of MTB complex and its resistance to second-line antibiotics

Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis or a closely related species and affecting over 10 million people worldwide. TB requires multidrug therapy over several months, which can fail due to mutations that result in drug resistance. Drug resistance accounted for over 400,000 estimated cases in 2020. Emergence and global spread of drug-resistant TB is a major medical and public health problem. Therefore, rapid and reliable detection of resistance-mediating mutations is essential for fast intervention and effective disease management at individual and public health level.

Drug resistance in TB is most commonly associated with first-line antibiotics, isoniazid and rifampicin, and requires tailored treatment with second-line anti-TB drugs, such as fluoroquinolones, bedaquiline and linezolid. Additional resistance to fluoroquinolones and at least one other of these “Group A” drugs leads to extensively drug-resistant (XDR-)TB, which is notoriously difficult to treat, using drugs with serious side effects over lengthy therapy. Closely monitoring drug-resistant strains equips doctors with information necessary to ensure most effective therapy and increase the chances of success for every TB patient.

LiquidArray® MTB-XDR VER 1.0 offers reliable reporting of resistances to the 5 WHO-endorsed drugs: fluoroquinolones (moxifloxacin and levofloxacin), linezolid, amikacin and ethambutol, from sputum or culture specimens. In a single well, the test allows detection of M. tuberculosis complex as well as up to 28 mutations in resistance-mediating gyrA, gyrB, rplC, rrl, rrs and embB genes, according to latest WHO findings. The molecular genetic assay is powered by the innovative LiquidArray® technology, providing next generation multiplexing in a familiar PCR format. Moreover, the results at a glance provide information on individual mutations, including differentiation between high-level and low-level resistance to moxifloxacin, allowing for instances of high-dose moxifloxacin treatment where low-level resistance is detected. Additionally, this feature alerts to instances where the certainty of resistance is currently not completely established but may do so in the future as more clinical and scientific data becomes available. The wealth of information generated in a single PCR reaction by LiquidArray® MTB-XDR makes the assay an invaluable tool in guiding the doctors to choosing the most relevant individual therapy.

LiquidArray® MTB-XDR VER 1.0 assay complements FluoroType® MTBDR VER 2.0, which reports resistances to rifampicin and isoniazid. FluoroType® MTBDR VER 2.0 is endorsed by the WHO as a test for the detection of pulmonary TB, and of rifampicin and isoniazid resistance, in people with signs and symptoms of pulmonary TB. The two assays can be run independently or, alternatively, in parallel or step-wise from the same DNA extraction. The possibility of reflex-testing from a single sample eliminates the necessity for a second patient sample, providing an efficient and time-saving diagnostic workflow for MDR- and XDR-TB from one sample. Starting with DNA extraction from decontaminated sputum or culture samples, and following PCR set-up, amplification and detection are performed with the FluoroCycler® XT. The FluoroSoftware® XT-IVD generates results at a glance, in an easy-to-use, easy-to-interpret test report. The streamlined workflow allows detection of resistance-conferring mutations in just 3 to 5.5 hours, depending on the number of samples, making the LiquidArray® MTB-XDR VER 1.0 assay an indispensable tool for the rapid diagnosis of XDR-TB.

Fast and reliable detection of second-line drug resistance

Rapid and reliable detection of resistance-mediating mutations is essential for determination of treatment courses to ensure successful outcomes. LiquidArray® MTB-XDR VER 1.0 offers a one-PCR-reaction solution for a comprehensive coverage of the most prevalent resistance-mediating mutations in the gyrA, gyrB, rplC, rrl, rrs and embB genes conferring resistances to fluoroquinolones, linezolid, amikacin and ethambutol. The highly specific and sensitive assay helps reduce delays in diagnosis and mitigate the risk of incorrect treatment regimens and unnecessary patient health deterioration.

Powered by LiquidArray®

LiquidArray® from Bruker is a next generation multiplexing PCR-based technology. It is underpinned by the unique features of the FluoroCycler® XT – Bruker’s high performance thermocycler. With precise temperature control and no optical cross-talk or colour compensation, assays are designed with a high number of targets per optical channel. LiquidArray® assays follow a familiar PCR format with melting curves automatically interpreted by FluoroSoftware® XT-IVD providing results at a glance in a user-friendly report.

Streamlined workflow from sample to result

Starting from decontaminated sputum or culture samples, DNA can be extracted manually using the FluoroLyse kit and PCR set up in a few simple steps. Alternatively, automated DNA extraction and PCR setup is performed on the GenoXtract® fleXT (12-96 samples). The choice of manual or automated extraction and PCR setup allows for a flexible workflow suitable for laboratories of any size.

The same DNA extract can be used for all mycobacteria assays that are based on LiquidArray® technology, provided that the sample material is validated for the selected assays. Whether run in parallel or in a reflex-testing based approach, the streamlined workflow saves time and the necessity for additional patient samples.

Our three LiquidArray®-based assays, FluoroType® MTBDR VER 2.0, FluoroType® Mycobacteria VER 1.0, and LiquidArray® MTB-XDR VER 1.0, provide the broadest coverage in mycobacteria diagnostics: MTBC detection, first- and second-line resistances and over 30 NTMs. Following PCR set-up, LiquidArray® amplification and detection are performed with the FluoroCycler® XT, and the integrated FluoroSoftware® XT-IVD software provides results at a glance in an easy-to-use easy-to-interpret test report.

 

Please contact your local representative for availability in your country.

Not for sale in the USA.

Legal manufacturer is Hain Lifescience GmbH, Nehren · Germany, info.mdx.de@bruker.com, Phone +49 (0) 7473-9451-0

The legal manufacturer of GenoXtract® fleXT is Hamilton Bonaduz AG, Via Crusch 8, CH-7402 Bonaduz, Switzerland.