VisionArray® MYCO Chip
VisionArray® Chip for MYCO Genotyping
The mycobacterial genera comprise nearly 200 species, which, for the purpose of diagnosis and treatment, have been grouped into three categories: M. tuberculosis complex (MTC), M. leprae, and non-tuberculous mycobacteria (NTM). The majority of the Mycobacterium species belongs to the NTM group and can be found in different environments. Some of these bacteria can cause life-threatening infections in humans and in recent years, the mortality and morbidity associated with NTMs has increased especially in immunocompromised patients worldwide. Treatment of NTMs is specific to each species, and therefore a clear distinction between the species present is of extreme importance. Reliable and rapid molecular diagnostics, which is provided by the VisionArray® MYCO Chip 2.0 are the basis of an adequate therapy.
Chip Description
The VisionArray® MYCO Chip 2.0 is designed to detect several clinically relevant mycobacterial species. All capture sequences and the positive control are set up on the Chip as duplicates and the guide dots as triplicates. The signals are visible on the Chip as dark blue areas. The automated evaluation of the results is performed by a VisionArray® Software.
Note
CE/IVD In vitro diagnostic medical device according to European Union directive 98/79/EC. CE IVD only available in certain countries. Please check the status in your country below:
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VisionArray® MYCO PreCise Master Mix 2.0
The VisionArray® MYCO PreCise Master Mix 2.0 is intended to be used to amplify and biotinylate specific sections of the ITS and, in case of the M. tuberculosis complex, the IS6110 region and, in case of M. chimaera, the SR4 region (Zozaya-Valdés et al 2017) of mycobacterial genomes by polymerase chain reaction (PCR) using DNA samples extracted from e.g. clinical specimens, pulmonary smears or cultivated samples.
The VisionArray® MYCO PreCise Master Mix 2.0 is designed to amplify mycobacterial sequences including but not limited to those detected by the corresponding VisionArray® MYCO Chip and, if present in the DNA sample, genomic sequences of the human HLA-DQA1 gene as a PCR positive control.
Note
CE/IVD In vitro diagnostic medical device according to European Union directive 98/79/EC. CE/IVD only available in certain countries. Please check the status in your country below:
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VisionArray® Detection Kit
The VisionArray® Detection Kit is intended to be used with a VisionArray® PreCise Master Mix and the corresponding VisionArray® DNA Chip for the qualitative detection of specific DNA sequences. The automated analysis has to be performed with a VisionArray® Software. The product is intended for professional use only. All tests using the product should be performed in a certified, licensed anatomic pathology laboratory under the supervision of a pathologist by qualified personnel.
Note
CE/IVD In vitro diagnostic medical device according to IVDR (European Union) 2017/746. CE/IVD only available in certain countries. Please check the status in your country below:
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VisionArray® MultiScan Software - Required hardware
The VisionArray® MultiScan Software is intended to be used for the detection and analysis of hybridization signals on VisionArray® Chips in combination with the corresponding chip file. The product is intended for professional use only. All tests using the product should be performed in a certified, licensed anatomic pathology laboratory under the supervision of a pathologist by qualified personnel.
For information on software installation services please contact your local dealer.
VisionArray® MultiScan
Laptop, scanner V600 photo, USB hub, external hard disk, computer mouse.
Note
CE/IVD In vitro diagnostic medical device according to IVDR (European Union) 2017/746. CE IVD only available in certain countries. Please check the status in your country below:
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VisionArray® SingleScan Software
The VisionArray® SingleScan Software is intended to be used for the detection and analysis of hybridization signals on VisionArray® Chips in combination with the corresponding chip file. The product is intended for professional use only. All tests using the product should be performed in a certified, licensed anatomic pathology laboratory under the supervision of a pathologist by qualified personnel.
For information on software installation services please contact your local dealer.
VisionArray® SingleScan
Laptop, scanner 8100, hand-held scanner, USB hub, external hard disk, computer mouse.
Note
CE/IVD In vitro diagnostic medical device according to IVDR (European Union) 2017/746. CE IVD only available in certain countries. Please check the status in your country below:
Check status by country
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