Quality control materials for infectious disease diagnostics

Millions of people are tested for infectious diseases every year. As you know, reporting an inaccurate test result can have devastating consequences for a patient. To increase confidence in reported results, multiple regulatory and accreditation bodies, including ISO, CLIA, CLSI and CAP recommend the consistent use of 3rd party controls.

As the most trusted brand in third-party quality controls, ZeptoMetrix is partnering with Bio-Connect, to help your laboratory consistently deliver accurate results. ZeptoMetrix manufactures an extensive range of quality controls and verification panels that are preferred by hospitals, clinics, and research organisations around the world for use with Nucleic Acid Testing (NAT), serological, and antigen-based assays. Products treated with ZeptoMetrix patented NATtrol™ process represent the industry-leading choices for NAT – the benchmark for external quality controls and verification materials for the diagnostic testing industry.

NATtrol controls are made with highly-purified microorganisms that have been processed to alter surface proteins and stabilised in an optimal state for research and testing. With intact nucleic acids, these products are non-infectious, refrigerator stable, and work with a wide variety of PCR-based assay systems.

Today, ZeptoMetrix is a renowned contributor in the global infectious disease diagnostics industry, recognised for developing and manufacturing a growing portfolio of reagents and kits. We also stock highly characterised seroconversion panels, for HIV, HBV, HCV, and Zika, using multiple samples collected from infected individuals across the course of their infection to capture markers that present at different stages of disease progression.

ZeptoMetrix corporate headquarters, R&D, quality, and technical operations teams are in Buffalo, New York, with the primary manufacturing, assembly/packaging, distribution, and customer service teams working out of our FDA-registered facility, located in Franklin, Massachusetts.

ZeptoMetrix is committed to understanding, implementing, and maintaining quality at all levels to meet customer needs, while adhering to applicable standards and regulatory requirements.

  • ZeptoMetrix Buffalo and Franklin are ISO 13485-2016 certified medical device manufacturers, FDA registered, and committed to all applicable Current Good Manufacturing Practices (CGMP) as outlined in FDA 21 CFR Part 820.
  • ZeptoMetrix Franklin is currently producing a line of IVD external run controls that are CE marked, which indicates conformity with IVDD 98/79/EC Annex IV.
  • ZeptoMetrix also upholds IVD, Quality Management System Audit for IVDR 2017/746, RUO capabilities and In Process compliance.

Bio-Connect supplies all their products in the Benelux. If you have any questions, please contact the helpdesk.

Major product lines from ZeptoMetrix

    • Molecular controls & panels for respiratory, BCID, gastrointestinal, healthcare-associated infections, women’s health & STI, and critical ID

We also offer:

    • Antigen controls

    • Serology products, including seroconversion panels

    • Immunoassay solutions

Why choose ZeptoMetrix?

ZeptoMetrix NATtrol Controls and Panels offer:

  • Purified and intact whole organism standards
  • Refrigerator stable (storage between 2 – 8 °C)
  • Available in different formats (single/multiple analytes, quantitative/qualitative)
  • Inactivated whole organisms are non-infectious and mimic a true clinical specimen
  • Full process controls to monitor extraction and amplification steps
  • Decreased need for repeat testing that saves time and money
  • Can be used across various molecular testing platforms and assays

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