NeuMoDx respiratory assays US

• 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 NeuMoDx Respiratory assay for SARS-CoV-2 enables your laboratory to provide reliable and timely results which allow your clinicians to deliver better patient care. 
 

NeuMoDx SARS-CoV-2 Assay Intended Use. 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 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 specimens from individuals suspected of COVID-19 by their healthcare provider. 

NeuMoDx SARS-CoV-2 Assay Intended Use.

The NeuMoDx SARS-CoV-2 Assay performed on the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx Molecular System(s)), is a real-time RT-PCR diagnostic test intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests.

This test is also for use with saliva specimens that are collected in a healthcare setting under the supervision of a healthcare provider (HCP) using the NeuMoDx Saliva Collection Kit from individuals suspected of COVID-19 as determined by an HCP due to symptoms.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.

Negative results must be combined with clinical observations, patient history and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

The NeuMoDx SARS-CoV-2 Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The NeuMoDx SARS-CoV-2 Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

• This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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 specimens.