Novodiag® COVID-19 Assay

High-performing, fully-automated on-demand testing for fast diagnosis of the SARS-CoV-2 virus.

Gloved hand holding medical device in lab setting.

    Overview

    Documents

    Training

    Easy to Use Solution with PCR Performance1

    The Novodiag COVID-19 assay, performed with the Novodiag® System, is a cartridge-based RT-PCR test for qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test uses nasopharyngeal swab samples from patients.1

    Smart Simplicity in On-demand Testing

    Dual Targeting1

    The assay detects dual targets of SARS-CoV-2 (E and N genes) and report them separately to avoid false negative results due to potential target mutations.

    Rapid & Safe Results

    The Novodiag rapid ‘sample-in, result-out’ system allows the fully automated detection of novel coronavirus in approximately 1 hour.2 Novodiag's closed system ensures the protection of healthcare professionals from possible contamination.

    Cellularity Control

    Cellularity control is added to the test to prevent false negative results. Detection of the cellularity control ensures the sample was taken properly and contains sufficient amount of sample material including human epithelial cells.

    User-Friendly Science

    The user-friendly nature of the Novodiag system means that it can be implemented in decentralised settings as well as high risk and hard to reach areas, without the need for highly trained personnel.

    Female lab technician observing Panther systems in a lab setting

    Simplify & Scale the Future of Diagnostics

    The Novodiag COVID-19 Assay is part of the Hologic Molecular Scalable Solution, a portfolio combining a broad, high performing assay menu with high throughput automation. Designed to flexibly scale to meet your needs, from a single patient rapid result to population level screening.

    User-friendly Precision Engineering

    A simple and fast way to pinpoint patients most at risk with on-demand testing. The small, quiet, stackable, fully-automated system combines easy-to-use functionality with PCR performance, to bring clinical confidence closer to patients.

    A Practical Workflow

    Step 1

    Lab technician adding sample to cartridge in a lab setting

    Add sample to cartridge and close with the cap

    Step 2

    Lab technician scanning cartridge in a lab setting

    Scan cartridge and sample ID

    Step 3

    Lab technician inserting cartridge into a system in a lab

    Insert cartridge and start test

    Step 4

    Lab technician using touch screen display in a lab setting

    Fully-automated results and clear reporting, LIS connectivity

    Evidence. Insight. Collaboration.

    Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.

      1. Novodiag® COVID-19 Instructions for Use V10-0 – May 2022, Espoo, FINLAND; Mobidiag Ltd. 2022
      2. Verification Report Novodiag® COVID-19 V4-0

      Hologic BV, Da Vincilaan 5, 1930 Zaventem, Belgium.

      EC Representative Information wherever applicable