Evaluation of a research use only luminex based assay for measurement of procalcitonin in serum samples.
Research use only (RUO) assays do not undergo a validation process similar to test kits used for clinical purposes. Several studies have suggested that RUO assays need to be validated prior to use in any research studies. We evaluated a research use only Luminex platform based assay for measuring serum procalcitonin levels (Bio-Plex ProTMHuman Acute Phase Multiplex Assay, Bio-Rad Laboratories, Hercules, CA) for comparability with an FDA cleared assay for procalcitonin (VIDAS B.R.A.H.M.S. PCT Assay, bioMérieux, Durham, NC). We tested 1,072 serum samples collected from patients with suspected sepsis in an intensive care unit setting for the comparison. There was poor correlation of the luminex based assay (r=0.081) with the VIDAS PCT Assay in the clinically relevant measurement range (<10 ng/mL). Additionally the Bio-Plex assay showed poor precision. Mass-spectrometry analysis of material eluted from PCT beads did not reveal any identifiable procalcitonin. The results show that research use only assays need to be validated to determine their suitability for research studies.
Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania Philadelphia, PA.
Charles
C
Garrigan
Department of Medicine, Perelman School of Medicine, University of PennsylvaniaPhiladelphia, PA; Department of Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of PennsylvaniaPhiladelphia, PA.
Jennifer
J
Han
Department of Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania Philadelphia, PA.
Pam
P
Tolomeo
Department of Cancer Biology, Fox Chase Cancer Center Philadelphia, PA.
Katherine J
KJ
Johnson
Department of Pathology and Laboratory Medicine, Weill Cornell Medicine New York, NY.
Stephen R
SR
Master
Department of Medicine, Perelman School of Medicine, University of PennsylvaniaPhiladelphia, PA; Department of Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of PennsylvaniaPhiladelphia, PA.
Ebbing
E
Lautenbach
Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania Philadelphia, PA.
Irving
I
Nachamkin
Biomarkers; luminex; procalcitonin; research use only (RUO) assays; sepsis