Diagnostic Press Releases
ZeptoMetrix® awarded In Vitro Diagnostic Regulation (IVDR) Certification
Buffalo, NY, October 3, 2023 — ZeptoMetrix® is pleased to announce it has been awarded an IVDR Quality Management System certificate from British Standards Institution BSI, NB 2797, one of the notified bodies under the new EU In Vitro Diagnostics Regulation (IVDR). This certificate applies to the majority of the current portfolio of CE marked ZeptoMetrix NATtrol™ quality control products that are the industry’s preferred brand for molecular diagnostic testing and are supplied ready-to-use as independent third-party quality control materials. With this significant certification step completed, ZeptoMetrix will focus on the implementation of updated product labelling over the next several months.
ZeptoMetrix® launches PROtrol™: Quality Control Material for the Lateral Flow Immunoassay Market
Buffalo, NY, May 16, 2023 — ZeptoMetrix® is excited to introduce PROtrol TM, a new line of products designed for antigen-based diagnostic methods. These third-party materials mimic a true clinical specimen and can be used to evaluate and monitor the performance of antigen-based assays, including lateral flow immunoassays for infectious diseases.
ZeptoMetrix® Launches New Flu/RSV/SARS-CoV-2 External Run Control
Buffalo, NY, July 26, 2022 — ZeptoMetrix launches its new external run control for Flu, RSV, SARS and CoV-2: NATFRC-ERC. This third-party molecular quality control can be used by laboratories to monitor the continued performance of their multiplexed respiratory assays. With target concentrations of 15,000 cp/mL for all four analytes, the launch of NATFRC-ERC represents an exciting addition to the ZeptoMetrix respiratory product line and is now available for pre-order.
ZeptoMetrix® Launches New Women’s Health Molecular Quality Controls
Buffalo, NY, July 14, 2022 — ZeptoMetrix, an Antylia Scientific company, today launches two new vaginal molecular QC controls, NATVPOS-6C Vaginal Positive Control and NATVNEG-6C Vaginal Negative Control, for in vitro diagnostic use. They are in stock and available for shipment. These latest third-party molecular controls provide additional confidence in the quality and reliability of clinical laboratory testing.
ZeptoMetrix® Launches NATtrol™ Bacteriophage MS2 Quantitative Stock Solution
Buffalo, NY, July 26, 2022 — ZeptoMetrix®, an Antylia Scientific™ company, today launches the NATtrol™ Bacteriophage MS2 quantitative stock: NATMS2-STQ. This product is intended for use as an internal process control for molecular diagnostic assays.