Demise of Polymerase Chain Reaction/Electrospray Ionization-Mass Spectrometry as an Infectious Diseases Diagnostic Tool

Volkan Özenci, Robin Patel, Måns Ullberg, Kristoffer Strålin

Research output: Contribution to journalReview article

24 Scopus citations

Abstract

Although there are several US Food and Drug Administration (FDA)-approved/cleared molecular microbiology diagnostics for direct analysis of patient samples, all are single target or panel-based tests. There is no FDA-approved/cleared diagnostic for broad microbial detection. Polymerase chain reaction (PCR)/electrospray ionization-mass spectrometry (PCR/ESI-MS), commercialized as the IRIDICA system (Abbott) and formerly PLEX-ID, had been under development for over a decade and had become CE-marked and commercially available in Europe in 2014. Capable of detecting a large number of microorganisms, it was under review at the FDA when, in April 2017, Abbott discontinued it. This turn of events represents not only the loss of a potential diagnostic tool for infectious diseases but may be a harbinger of similar situations with other emerging and expensive microbial diagnostics, especially genomic tests.

Original languageEnglish (US)
Pages (from-to)452-455
Number of pages4
JournalClinical Infectious Diseases
Volume66
Issue number3
DOIs
StatePublished - Jan 18 2018

Keywords

  • bacteremia
  • diagnostics
  • mass spectrometry
  • PCR
  • sepsis

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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