NeoLSD 7plex LC-MSMS kit

The NeoLSD 7plex LC-MSMS kit represents the latest advancement in newborn screening for lysosomal storage disorders (LSDs), combining innovation, efficiency, and clinical confidence in a single, powerful solution. It is the first commercial CE-IVDR kit to include screening for Hunter syndrome (MPS II), broadening the reach of newborn screening and strengthening the capabilities of laboratories worldwide.

Building upon the success of the globally trusted NeoLSD MSMS kit, which has already been used to screen millions of newborns, the NeoLSD 7plex kit expands the number of disorders detectable from six to seven. The kit enables simultaneous measurement of enzymatic activities for acid-β-glucocerebrosidase, acid-sphingomyelinase, acid-α-glucosidase, β-galactocerebrosidase, α-galactosidase A, α-L-iduronidase, and iduronate-2-sulfatase, all from two dried blood spot punches consolidated into one injection. This efficiency translates into optimized laboratory workflows, high throughput, and streamlined resource use.

The NeoLSD 7plex kit leverages LC-MSMS technology, recognized for its expanded analyte coverage and high specificity. By enabling superior separation of analytes and minimizing false positives, LC-MSMS ensures diagnostic reliability, an essential requirement for laboratories performing high-throughput newborn screening.

The NeoLSD 7plex LC-MSMS kit is optimized for use with the QSight® 225MD UHPLC Screening System*, delivering a streamlined workflow with Simplicity 3Q™ MD Software designed for high-throughput LC assays with the following features:

• Automated peak detection and integration
• Peak quality flagging for improved reliability
• Injection counter for individual LC-columns

Additionally, the MSMS Workstation** software supports the workflow by:

• Tracking samples through multi-punch workflows
• Combining data from separate preparation pathways
• Automating data entry -enables the import of IS concentrations, QC targets and SD from QC certificate with a barcode reader
• Enabling easy optimization of cut-offs
• Quick result acceptance and customizable exporting and reporting tools

This comprehensive approach minimizes complexity, increases throughput, and supports laboratories in delivering timely, accurate results.

The kit is CE-IVDR compliant, reflecting Revvity’s commitment to meeting the highest regulatory and quality standards. By ensuring compliance and reproducibility, the NeoLSD 7plex kit provides laboratories with confidence in both their processes and their results.

For healthcare providers and families, early detection of lysosomal storage disorders can be life changing. Disorders such as MPS II, Pompe, and Krabbe can progress rapidly without intervention, making timely diagnosis through newborn screening essential for improved clinical outcomes. With the NeoLSD 7plex kit, laboratories can offer broader coverage - helping clinicians initiate interventions earlier and supporting better long-term outcomes for affected infants.

In summary, the NeoLSD 7plex LC-MSMS kit is more than an assay; it is a complete solution designed to empower newborn screening programs with:

• Broader screening capabilities with the inclusion of MPS II
• Specificity and accuracy through LC-MSMS technology
• Seamless software integration for streamlined data handling and reporting
• Trusted global expertise, built on decades of innovation and millions of newborns screened worldwide

By delivering unmatched efficiency, accuracy, and compliance, the NeoLSD 7plex LC-MSMS kit sets a new standard in newborn screening for lysosomal storage disorders - giving laboratories the tools to expand testing, improve outcomes, and transform the future of newborn health.

*MSMS Workstation is a CE marked in vitro diagnostic device, compliant with IVD regulation (EU) 2017/746

**QSight 225MD UHPLC Screening System is a CE marked in vitro diagnostic device, compliant with IVD regulation (EU) 2017/746