High-speed Turbidimetric Calprotectin Immunoassay - A New Rapid-response Biomarker for Sepsis and other Diseases and Conditions

Prosjektet har som mål å frembringe og klinisk dokumentere en målemetode og reagenser for automatisk måling av proteinet kalprotektin i serum og plasmaprøver, og klinsik verifisere disse reagensers verdi.Hoveufordringen i feltet har vært at tidligere metoder har vært langsomme og upraktiske, og at kalibreringen ikke har vært tilfredsstillende. Posjektet har lykkes i å gjennomføre massespektroskopisk analayse av antigener og kalibratorer, samt å fremstille antigener og kalibratorer rekombinant. Reagenser har blitt ferdigstilt, og klinisk verifisering pågår i Norge, Sverige og USA. Det er videre lykke å fremstille rekombinant calprotectin dimer og S100A8 og S100A9 monomere av kalprotektin, for fremstilling av kalibratorer og kontroller samt antigener til immunisering av antistoffproduserende høner. Det er således oppnådd en forbedret standardisering av målemetodene.

Background: Calprotectin is a major component of neutrophils that are the first line of defence at a site of infection. Calprotectin is the first biomarker to be released into the blood stream during infection. Other biomarkers such as CRP are generated in the liver and are detected some time after an initial infection. A New Bioarker for Sepsis: The immediate release of calprotectin at the onset of infection makes calprotectin an ideal marker for sepsis and acute bacterial diseases. Summary: Gent ian AS has - over the last 5 years and through extensive R&D - developed a new nanoparticle immunoassay technology using avian antibodies. The company has a European patent for its technology, and patents are pending in other jurisdictions. Gentian AS has been co-ordinator for a FP6 STREP project, and presently sells 10+ million nanoparticle immunoassays based on in its new technology. Gentians annual turnover is 13 million NOK and rapidly growing. Gentian has invented a new formulation of nanoparticles conjugated to avian antibodies that enables sensitive measurement of calprotectin in a very wide concentration range in a highly automated non-separation immunoassay on clinical chemistry automates. The formulation supports a diverse range of body fluids including blood, plasma and faecal extracts. Gentian has also invented a new method for antigen preparation and standardisation and control materials for calprotectin that will be combined with the new nanoparticle materials. Furthermore, Gentian will, with its partners University of California Los Angeles (UCLA), Uppsala University Hospital and The Mayo Clinic, investigate the use of nanoparticle-based avian antibody immunoassays in new and established clinical areas for calprotectin measurements. The results will form the basis for new commercial non-separation calprotectin immunoassay products for routine clinical chemistry analysers, which will grow even faster than the Gentian cystatin C assay.