The European Commission has approved and granted the CE mark (Conformité Européene) to Abbott's PLEX-ID molecular system including three assays (PLEX-ID Viral IC Spectrum, PLEX-ID BAC Spectrum BC and PLEX-ID Flu).
PLEX-ID combines sensitivity and specificity of polymerase chain reaction (PCR) technology with the precision and accuracy of mass spectrometry for the identification and characterisation of broad groups of microorganisms which cause infections in patients.
The system can characterise a number of microorganisms directly from clinical specimens, minimising both time and laboratory work required to provide physicians with information for treating patients.
Abbott Ibis Biosciences business head Murthy Simhambhatla said PLEX-ID is diagnostic technology capable of identifying a range of bacteria, viruses, fungi and certain parasites in hours.
"The introduction of the PLEX-ID provides physicians and laboratorians a revolutionary new platform for the rapid etiologic identification of a wide variety of pathogens in patients," Simhambhatla added.
The PLEX-ID Viral IC Spectrum assay is designed to detect and identify 11 viral families with more than 250 species of systemic viral pathogens directly from plasma specimens.
The PLEX-ID BAC Spectrum BC assay can detect and identify nearly 400 species of bacteria, as well as detect the presence of genetic markers that determine bacterial resistance to certain antibiotics. The company plans to launch a modified version of the BC assay in Europe later this year to analyse blood samples immediately after reaching the lab rather than having to wait for the organism to grow in culture.
PLEX-ID Flu is intended for detection and identification of known influenza A viruses, newly emerging influenza A strains and influenza B.