NeuMoDx transplant-associated virus assays

• 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

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

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 quantitative NeuMoDx transplant-associated virus assays for cytomegalovirus (CMV), human Epstein-Barr virus (EBV), BK virus (BKV), human adenovirus (HAdV), herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2) and human betaherpesvirus 6A (HHV-6A) enable your laboratory to provide reliable and timely viral load results which allow your clinicians to deliver better patient care. 

NeuMoDx simplifies infectious disease diagnostics so you can get faster results for your patients

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 CMV Quant assay is an automated, in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human plasma specimens.  

The NeuMoDx EBV Quant assay is an automated, in vitro nucleic acid amplification test for the quantitation of human EBV DNA in plasma.

The NeuMoDx EBV Quant assay 2.0 is an automated in vitro nucleic acid amplification test for the quantification of human EBV DNA in EDTA plasma from immunocompromised transplant patients. 

The NeuMoDx BKV Quant assay is an automated, in vitro nucleic acid amplification test for the identification and quantification of BKV DNA in samples extracted from human plasma/serum and urine.

The NeuMoDx HAdV Quant assay is an automated, in vitro nucleic acid amplification test for the identification and quantification of AdV DNA in samples extracted from human plasma/serum and urine.

The NeuMoDx HSV-1/HSV-2 Quant assay is an automated, in vitro nucleic acid amplification test for the quantification and differentiation of HSV-1 DNA and/or HSV-2 DNA in EDTA plasma from immunocompromised transplant patients.

The NeuMoDx HHV-6 Quant assay is an automated, in vitro nucleic acid amplification test for the quantification and differentiation of HHV-6A DNA and/or HHV-6B DNA in EDTA plasma from immunocompromised transplant patients.

The NeuMoDx CMV Quant assay enables detection and quantitation of CMV DNA over the linear range of the assay for CMV genotypes gB1 through gB4 in plasma samples from CMV-infected individuals.  

The NeuMoDx EBV Quant assay can be used for in vitro detection and quantitation of EBV DNA to assess response to antiviral treatment using  plasma samples from EBV-infected individuals.

The NeuMoDx EBV Quant assay 2.0 is for use as an aid in monitoring EBV DNA levels in plasma to assess viral response to treatment. This assay can be used in conjunction with clinical presentation and other laboratory markers of disease progression for the clinical management and monitoring of EBV infection.  

The NeuMoDx BKV Quant assay is intended for use as an aid in the diagnosis and monitoring of BKV infection together with other clinical and laboratory findings.

The NeuMoDx HAdV Quant assay is intended for use as an aid in the diagnosis and monitoring of AdV infection together with other clinical and laboratory findings.

The NeuMoDx HSV-1/HSV-2 Quant assay is intended for use as an aid in the monitoring of HSV-1 and/or HSV-2 DNA levels in EDTA plasma. This assay is intended for use in conjunction with clinical presentation and other laboratory markers of disease progression for the clinical management and monitoring of HSV-1 and/or HSV-2 infections.

The NeuMoDx HHV-6 Quant assay is intended for use as an aid in the monitoring of HHV-6A and/or HHV-6B DNA levels in EDTA plasma. This assay is for use in conjunction with clinical presentation and other laboratory markers of disease progression for the clinical management and monitoring of HHV-6A and/or HHV-6B infections.

The NeuMoDx CMV, EBV, EBV 2.0, BKV, hAdV, HSV 1/2 and HHV-6 Quant assays can be used as an aid in the management of patients with diagnosed infections. The results from these assays must be interpreted within the context of all relevant clinical and laboratory findings. 

The NeuMoDx CMV, EBV, EBV 2.0, BKV, hAdV, HSV-1/HSV2 and HHV-6A/B Quant assays are not intended for use as a screening test for blood or blood products or to diagnose the clinical status of infection.

* Calibrators and controls for the CMV, EBV and EBV 2.0 NeuMoDx transplant-associated assays are stored frozen. Refer to Information for Use for exact requirements.

The NeuMoDx BKV, HAdV, HSV1/2 and HSV-6 assay are manufactured by Sentinel Diagnostics and uses STAT-NAT technology; the associated calibrators and external controls require reconstitution with the dedicated buffers provided.