I received the following from Immunexpress. I got excited when I saw the correlation coefficient but then realized the article just indicates that the two sets of samples were comparable, so the test may easily be applied to the lab workflow using commonly taken samples. The article does not answer the question of how valuable was Septiscore in diagnosing sepsis especially at early onset stages.
FL
Data Validating EDTA Blood as Sample Type for SeptiCyte® RAPID Presented at the Association for Molecular Pathology 2022 Annual Meeting
A multi-site study confirms the use of undiluted EDTA blood for the SeptiCyte RAPID sepsis assay
SEATTLE and BRISBANE, Australia, Nov. 3, 2022 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the presentation of an abstract at the Association for Molecular Pathology 2022 Annual Meeting in Phoenix. The abstract, entitled, "Multi-site validation of EDTA blood as a sample type for SeptiCyte® RAPID CE-IVD, a near-patient diagnostic test for sepsis on the Biocartis Idylla™ System," will be presented as a poster on Saturday, November 5, 2022 from 9:15 – 10:15 a.m. PDT.
Immunexpress (PRNewsfoto/Immunexpress, Inc.)
The multi-site study was conducted at University Hospital Bonn in Germany and Hospital Foch in Suresnes, France. It investigated Immunexpress' sepsis diagnostic tool SeptiCyte RAPID CE-IVD in 46 clinically confirmed sepsis and non-sepsis patients. A high degree of correlation (R2 = 0.95) was observed when comparing the SeptiScore® values observed in these patients, processed either from undiluted EDTA blood collection tubes or from a PAXgene® blood RNA tubes. The reproducibility of the EDTA blood result was further assessed by running a subset of the samples in triplicate.
"These data validate the use of undiluted EDTA-anticoagulated blood as an additional sample type for the SeptiCyte® RAPID CE-IVD assay. The ability to process EDTA-anticoagulated blood without further preparation steps makes the assay extremely accessible to all clinical and laboratory settings and work- flows, moreover since only a small blood volume of 240µL whole blood is required," said Dr. Marijo Parcina, investigator and Associate Professor at the Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn.
Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress, added, "These results further expand the clinical utility of our SeptiCyte® RAPID assay. Because hematology testing is generally performed on EDTA blood, this sample type is universally collected in hospital settings, is often the first to be drawn, and thus enables the quantification of a sepsis probability in suspected patients at the moment potentially life-saving clinical decisions must be made."
SeptiCyte® RAPID EDTA blood compatible cartridges may be purchased in Europe via our distribution partner Biocartis. Immunexpress expects SeptiCyte® RAPID EDTA cartridges will be available in the United States by June 2023.