Ida Sjøstrøm, Gunn Helen Malmstrøm, Arne Røseth
Lovisenberg Diakonale Hospital, Unger Vetlesen Research Institute. Oslo, Norway.
arneroseth@gmail.com

Introduction
Therapeutic drug monitoring (TDM) has become standard clinical practice over the last few years, but has been hampered by 2 aspects; the high cost and that ELISA based test delays the result with several days. Approx. 44% of the pts are correctly dosed, 21% under dosed and 26% had IFX levels >7. This accounts for nearly half of all pts do need dose optimization.

Aims of the study
The study had two aspects; first is to correlate a CE -marked rapid test for IFX trough level, the Quantum Blue Infliximab test (QB-IFX) (Bühlmann Laboratories, Basel, Switzerland) to an ELISA. Secondly, to correlate the performance of such a test performed by; A)a nurse and B) a trained laboratory person

Methods
The study comprised 19 pts with IBD receiving IFX treatment.
Part A : A nurse (IS) received one hour of “laboratory” training before running the QB-IFX under supervision of AR. The serum was thawed, diluted 10uL in 190 uL buffer and vortexed for 5 sec. 70uL was applied to the test cassette and read after 15 min.
Part B: The same procedure was followed but this time by a highly experienced lab technician (GHM)

Results
The was a very good correlation between the QB-IFX rapid test and the laboratory ELISA test, r= 0.94, p< 0.001.