title: Functional immunoassay technology (FIT), a new approach for measuring physiological functions: application of FIT to measure glomerular filtration rate (GFR).
abstract: This is the first description of functional immunoassay technology (FIT), which as a diagnostic tool has broad application across the whole spectrum of physiological measurements. In this paper, FIT is used to measure the renal clearance of an ultra low-dose administration of a clinically available contrast reagent for the purpose of obtaining an accurate glomerular filtration rate (GFR) measurement. Biomarker-based GFR estimates offer convenience, but are not accurate and are often misleading. FIT overcomes previous analytic barriers associated with obtaining an accurate GFR measurement. We present the performance characteristics of this diagnostic test and demonstrate the method by directly comparing GFR values obtained by FIT to those obtained by an FDA approved nuclear test in 20 adults. Two subjects were healthy volunteers and the remaining 18 subjects had diagnosed chronic kidney disease, with 12 being kidney transplant recipients. Measured GFR values were calculated by the classic UV/P method and by the blood clearance method. GFR obtained by FIT and the nuclear test correlated closely over a wide range of GFR values (10.9-102.1 ml.min(-1).1.73 m(-2)). The study demonstrates that FIT-GFR provides an accurate and reproducible measurement. This nonradioactive, immunoassay-based approach offers many advantages, chiefly that most laboratories already have the equipment and trained personnel necessary to run an ELISA, and therefore this important diagnostic measurement can more readily be obtained. The FIT-GFR test can be used throughout the pharmaceutical development pipeline: preclinical and clinical trials.
authors.affiliation: BioPhysics Assay Laboratory (BioPAL), Incorporated, 80 Webster St., Worcester, MA 01603, USA. cs@BioPAL.com
authors.forename: Christopher Peter
authors.initials: CP
authors.lastname: Reinhardt
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Germain
authors.forename: Ernest V
authors.initials: EV
authors.lastname: Groman
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Mulhern
authors.forename: Rajesh
authors.initials: R
authors.lastname: Kumar
authors.forename: Dennis E
authors.initials: DE
authors.lastname: Vaccaro