NeuMoDx sexual and reproductive health assays

For sexual- and reproductive-health-related infectious disease using real-time PCR molecular testing

NeuMoDx HPV Test Strip

Cat. No. / ID: 617007

For 96 tests: Dried PCR reagents containing HPV- and βG specific TaqMan probe and primers.

Assay

HPV

CT/NG

TV/MG

GBS

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As of June 6, 2024 NeuMoDx 96 and 288 Molecular Systems will be discontinued. Please contact your sales representative for support.

The NeuMoDx system and assays are intended for in vitro diagnostic use. Product availability may vary from country to country based on regulations and approvals. 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

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 sexual and reproductive health (SRH) assays for human papillomavirus (HPV), Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG) and group B Streptococcus (GBS) enable your laboratory to provide reliable and timely results which allow your clinicians to deliver better patient care.

Performance

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-accessanalyzers. 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 provideclinicians 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 thesystem 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 HPV Assay, as performed on the NeuMoDx 96 and NeuMoDx 288, is a rapid, automated, in vitro diagnostic, real-time PCR-based nucleic acid amplification assay for the qualitative detection of high-risk types of HPV DNA in cervical specimens. The test specifically identifies HPV16 and HPV18 while concurrently detecting the other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68) at clinically relevant infection levels.

The NeuMoDx CT/NG Assay is an automated, qualitative in vitro nucleic acid amplification test for the direct detection and differentiation of CT and/or NG DNA in urogenital specimens.

The NeuMoDx TV/MG Assay is a rapid, automated, qualitative in vitro nucleic acid amplification test for the direct detection and differentiation of DNA from TV and/or MG in clinical urogenital specimens.

The NeuMoDx GBS Assay is a qualitative in vitro diagnostic test designed to detect GBS DNA from 18-24–hour LIM broth enrichments of vaginal/rectal swabs from pregnant women.

Applications

The NeuMoDx HPV Assay enables qualitative detection of high-risk types of HPV DNA from cervical specimens.

The NeuMoDx CT/NG Assay enables qualitative direct detection and differentiation of CT and/or NG DNA in urogenital specimens.

The NeuMoDx GBS Assay enables qualitative detection of GBS DNA from 18-24 hour LIM broth enrichments of vaginal/rectal swabs from pregnant women.

The NeuMoDx TV/MG Assay enables qualitative direct detection and differentiation of DNA from TV and/or MG in clinical urogenital specimens.