IVD reagents and consumables for use in NeuMoDx instrument open mode

To support customers developing in-house assays using real-time PCR molecular testing

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

 *Refer to the product information for exact requirements for use.

 

Product Details

NeuMoDx Molecular Systems simplifies infectious disease diagnostics so you efficiently deliver results to physicians caring for patients. The LDT-assay capability for DNA and RNA enables your laboratory to provide reliable and timely results which allow your clinicians to deliver personalized 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).

Customers can build their own LDT workflows  on the NeuMoDx platforms, which offer higher throughput, improved performance and increased efficiency by eliminating the waste associated with technologies that require reconstitution of lyophilized reagents.  

The NeuMoDx LDT Primer/Probe Strip is an empty, 16-well strip used for LDTs on the NeuMoDx System. NeuMoDx reagents, such as NeuMoDx Extraction Plate, NeuMoDx lysis Buffers, NeuMoDx Wash Reagent and NeuMoDx Release Reagent, make the development of LDTs streamlined and efficient, allowing sample extraction to be combined with real-time PCR in one system. The NeuMoDx LDT Primer/Probe Strip is universally used for all LDTs processed on the NeuMoDx System. 


The NeuMoDx LDT Master Mix, DNA, is a 16-well strip containing a proprietary, room-temperature stable, real-time PCR master mix that, when used with assay-specific primers and probe(s), enables a laboratory to rapidly develop and implement LDTs on the NeuMoDx Systems open mode. The NeuMoDx LDT Master Mix Test Strip, DNA, provides all the reagents required for real-time PCR except the LDT-specific primers and probe(s), which you provide. 


The NeuMoDx LDT Master Mix, RNA, is a 16-well strip containing a proprietary, room-temperature stable, real-time RT-PCR master mix that, when used with assay specific primers and probe(s), enables a laboratory to rapidly develop and implement LDTs on the NeuMoDx Systems. The NeuMoDx LDT Master Mix Test Strip, DNA, provides all the reagents required for real-time PCR except the LDT-specific primers and probe(s), which you provide. 
Once validated by your laboratory as part of the customer built in LDT workflow, these reagents can be used as a key component for rapid automation of the customer developed LDT workflow.

Procedure

LDT assays can be performed on the NeuMoDx™ platforms which offer higher throughput, improved performance and increased efficiency by eliminating the waste associated with technologies that required reconstitution of lyophilized reagents.  

The NeuMoDx Laboratory Developed Test (LDT) assay capability for DNA and RNA enables your laboratory to provide reliable and timely results which allow your clinicians to deliver better patient care. 

The NeuMoDx LDT Primer/Probe Strip is an empty, 16-well strip used for laboratory developed tests (LDTs) on the NeuMoDx 288 Molecular System and the NeuMoDx 96 Molecular System (NeuMoDx System(s)). NeuMoDx Systems, in conjunction with NeuMoDx reagents such as NeuMoDx Extraction Plate, NeuMoDx Lysis Buffers, NeuMoDx Wash Reagent and NeuMoDx Release Reagent make the development of LDTs streamlined and efficient, combining sample extraction with real-time PCR in one system. The NeuMoDx LDT Primer/Probe Strip is universally used for all LDTs processed on the NeuMoDx System. 

The NeuMoDx LDT Master Mix (MM), DNA is a 16-well strip containing a proprietary, room temperature stable, real-time PCR master mix that, when used in conjunction with assay specific primers and probe(s), enables a laboratory to rapidly develop and implement laboratory developed tests (LDTs) on the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System(s)). Other than the LDT specific primers and probe(s), the NeuMoDx LDT MM Test Strip, DNA incorporates all the reagents required for real-time PCR. Once validated by the user’s laboratory as part of the LDT, this reagent can be used as a key component for rapid automation of the LDT.

The NeuMoDx LDT Master Mix, RNA is a 16-well strip containing a proprietary, room temperature stable, real-time RT-PCR master mix that, when used in conjunction with assay specific primers and probe(s), enables a laboratory to rapidly develop and implement laboratory developed tests (LDTs) on the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System(s)). Other than the LDT specific primers and probe(s), the NeuMoDx LDT Master Mix, RNA incorporates all the reagents required for real-time RT-PCR. Once validated by the user’s laboratory as part of the LDT, this reagent can be used as a key component for rapid automation of the LDT.

 

Applications

The NeuMoDx IVD reagents and consumables for use in the NeuMoDx instrument open mode workflow can be used by customers to build their own LDT workflows. 

Resources

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