NeuMoDx HBV External Controls

• 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 blood borne virus 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 blood borne virus assays for human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) 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 288 and NeuMoDx 96 Molecular 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 System provides 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 System can also be used as an open system to process lab-developed-tests (LDTs).

The NeuMoDx HIV-1 Quant Assay is an automated, quantitative and qualitative in vitro diagnostic nucleic acid amplification test designed for detection and quantitation of HIV-1 RNA in human plasma.

The NeuMoDx HBV Quant Assay is an automated, in vitro nucleic acid amplification test for the detection and quantitation of HBV DNA in human plasma and serum specimens.

The NeuMoDx HCV Quant Assay is an automated, in vitro nucleic acid amplification test for the detection and quantitation of hHCV RNA in human plasma and serum specimens.  
A sample process control is included in each of the assays to help monitor the presence of potential inhibitory substances as well as other issues that might be encountered during the extraction and amplification processes.

The NeuMoDx HIV-1 Quant Assay enables quantitation of HIV-1 RNA over the linear range of the assay for HIV-1 group M (subtypes A, B, C, D, F, G, H, K, CRF01_AE, CRF02_AG) N, O, and P. The NeuMoDx HIV-1 Quant Assay can also be used as a supplemental test for specimens that have repeat reactive results with approved HIV immunoassays and as a confirmation of HIV-1 infection.

The NeuMoDx HBV Quant Assay enables quantitation over the linear range of the assay for HBV genotypes A through H in HBV-infected individuals. 

The NeuMoDx HCV Quant Assay enables quantitation over the linear range of the assay for HCV RNA genotypes 1 to 6 HCV in HCV antibody positive infected individuals.

The NeuMoDx HIV-1 Quant Assay, NeuMoDx HBV Quant Assay and NeuMoDx HCV Quant Assay 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 HIV-1 Quant Assay, NeuMoDx HBV Quant Assay and NeuMoDx HCV Quant Assay are not intended for use as a screening test for blood or blood products or to diagnose the clinical status of HIV-1, HBV or HCV infection.