NeuMoDx respiratory assays

NeuMoDx respiratory assays are intended for in vitro diagnostic use. Product availability may vary from country to country. Contact your country representative for further details.

Features

  • Flexible assay testing, with true continuous random-access that is scalable to meet your needs
  • Room-temperature-stable reagents minimize the need for cold-chain shipment and storage*
  • Timely and reliable results available in 50–90 minutes 
  • Intuitive three-step workflow with minimal hands-on time
  • Run IVD and laboratory-developed assays on a single platform using the same reagents and easy, reproducible workflow

* Controls for the NeuMoDx assays are stored frozen. Refer to the product Information for User for exact requirements.

 

Product Details

Assays are performed on the high-throughput NeuMoDx platforms, which deliver improved performance and increased efficiency by eliminating the waste associated with technologies that required reconstitution of lyophilized reagents. The NeuMoDx Respiratory assays for influenza A virus (Flu A), influenza B virus (Flu B), respiratory syncytial virus (RSV) and SARS-CoV-2 RNA (multiplex), SARS-CoV-2 and Strep A/C/G (GAS) enable your laboratory to provide reliable and timely results which allow your clinicians to deliver better patient care.

Principle

NeuMoDx Molecular Systems provide a fully integrated molecular diagnostic process from sample to result. The NeuMoDx Systems are fully automated, continuous random-access analyzers. Liquid handling and transport is achieved through proven robotic technologies. The intuitive touch-screen interface displays all the information needed to operate the instrument and view the system status.

The NeuMoDx Molecular Systems provide automated extraction of nucleic acids from multiple specimen types, as well as automated real-time amplification and detection of target nucleic acid sequences by fluorescence-based, real-time PCR. 

Our proprietary and unitized microfluidic cartridge features autonomous lanes, allowing simultaneous processing of different assays.

Our unique integration of robotics and advanced microfluidics reduces operation to three simple steps, providing industry-leading usability. These capabilities dramatically improve lab productivity and the ability to provide clinicians with critical information in a timely manner.

A broad IVD menu and room-temperature stable reagents and consumables offer unmatched flexibility while minimizing waste associated with reagent preparation, hands-on time and batch testing. The flexibility of the system allows the consolidation of your infectious disease portfolio onto one system. The versatile NeuMoDx Molecular Systems can also be used as an open system to process lab-developed-tests (LDTs).

The NeuMoDx FluA/FluB/RSV/SARS-CoV-2 assay is a multiplexed, in vitro real-time RT-PCR diagnostic test for the simultaneous qualitative detection and differentiation of FluA/FluB/RSV/SARS-CoV-2 from nasopharyngeal swab specimens collected in transport medium from individuals with signs and symptoms of Influenza like illness. 

The NeuMoDx FluA/FluB/RSV/SARS-CoV-2 External Controls are a component of the NeuMoDx FluA/FluB/RSV/SARS-CoV-2 assay.

The NeuMoDx Strep A/C/G Vantage assay, as performed on the NeuMoDx Molecular Systems, is a rapid, automated, qualitative in vitro nucleic acid amplification test for the direct detection and differentiation of Streptococcus pyogenes (Group A β- hemolytic Streptococcus [GAS]) and Streptococcus dysgalactiae (pyogenic Group C and G β-hemolytic Streptococcus, including subsp. dysgalactiae group C, and Streptococcus dysgalactiae subsp. equilisimilis Group C and G [GCS/GGS]) in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. 

The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay is a multiplex, rapid, automated, qualitative in vitro real-time RT-PCR diagnostic test for simultaneous direct detection and differentiation of Flu A, Flu B, RSV and SARS-CoV-2 RNA from nasopharyngeal swabs in transport medium from individuals with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. 

The NeuMoDx SARS-CoV-2 Assay is a real-time RT-PCR diagnostic test for the qualitative detection of SARS-CoV-2 coronavirus RNA in nasal, nasopharyngeal and oropharyngeal swabs in transport medium, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.

 

Applications

The NeuMoDx FluA/FluB/RSV/SARS-CoV-2 Assay is a multiplexed diagnostic test for the simultaneous qualitative detection and differentiation of Flu A, Flu B, RSV and SARS-CoV-2 RNA from nasopharyngeal swab specimens.  

The NeuMoDx Strep A/C/G Vantage Assay, is a qualitative diagnostic test for the direct detection and differentiation of Strep A/C/G in throat swab specimens.

The NeuMoDx FluA/FluB/RSV/SARS-CoV-2 Vantage Assay is a multiplex qualitative diagnostic test that can be used for simultaneous direct detection and differentiation of Flu A, FluB, RSV and SARS-CoV-2 RNA from nasopharyngeal swabs in transport medium. 

The NeuMoDx SARS-CoV-2 Assay, is a diagnostic test that can be used for the qualitative detection of SARS-CoV-2 coronavirus RNA in nasal, nasopharyngeal and oropharyngeal swabs in transport medium, and bronchoalveolar lavage (BAL) specimens.

Resources

Safety Data Sheets (1)
Certificates of Analysis (1)