Artificial intelligence / machine-learning tool for post-market surveillance of in vitro diagnostic assays.

Journal: New biotechnology
Published Date:

Abstract

The study compares an artificial intelligence technology with traditional manual search of literature databases to assess the accuracy and efficiency of retrieving relevant articles for post-market surveillance of in vitro diagnostic and medical devices under the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation. Over a 3-year period, literature searches and technical assessment searches were performed manually or using the Huma.AI platform to retrieve relevant articles related to the safety and performance of selected in vitro diagnostic and medical devices. The manual search involved refined keyword searches, screening of titles/abstracts / full text, and extraction of relevant information. The Huma.AI search utilized advanced caching techniques and a natural language processing system to identify relevant reports. Searches were conducted on PubMed and PubMed Central. The number of identified relevant reports, precision rates, and time requirements for each approach were analyzed. The Huma.AI system outperformed the manual search in terms of the number of identified relevant articles in almost all cases. The average precision rates per year were significantly higher and more consistent with the Huma.AI search compared with the manual search. The Huma.AI system also took significantly less time to perform the searches and analyze the outputs than the manual search. The study demonstrated that the Huma.AI platform was more effective and efficient in identifying relevant articles compared with the manual approach.

Authors

  • Joanna Reniewicz
    QIAGEN Wrocław, ul. Powstańców Śląskich 95, 53-332 Wrocław, Poland.
  • Vinay Suryaprakash
    QIAGEN GmbH, Qiagen Str. 1, 40724 Hilden, Germany.
  • Justyna Kowalczyk
    QIAGEN Wrocław, ul. Powstańców Śląskich 95, 53-332 Wrocław, Poland.
  • Anna Blacha
    QIAGEN Manchester Ltd, CityLabs, 2.0 Hathersage Rd, M13 0BH Manchester, UK. Electronic address: anna.blacha@qiagen.com.
  • Greg Kostello
    HUMA.AI, San Francisco, CA, USA.
  • Haiming Tan
    Huma.AI, 3000 El Camino Real, Building 4, Suite 200-69, Palo Alto, CA 94306, USA.
  • Yan Wang
    College of Animal Science and Technology, Beijing University of Agriculture, Beijing, China.
  • Patrick Reineke
    Huma.AI, 3000 El Camino Real, Building 4, Suite 200-69, Palo Alto, CA 94306, USA.
  • Davide Manissero
    QIAGEN Manchester Ltd, CityLabs, 2.0 Hathersage Rd, M13 0BH Manchester, UK.