Analytical evaluation of the automated galectin-3 assay on the Abbott ARCHITECT immunoassay instruments.
BACKGROUND
Galectin-3 is secreted from macrophages and binds and activates fibroblasts forming collagen. Tissue fibrosis is central to the progression of chronic heart failure (CHF). We performed a European multicentered evaluation of the analytical performance of the two-step routine and Short Turn-Around-Time (STAT) galectin-3 immunoassay on the ARCHITECT i1000SR, i2000SR, and i4000SR (Abbott Laboratories).


METHODS
We evaluated the assay precision and dilution linearity for both routine and STAT assays and compared serum and plasma, and fresh vs. frozen samples. The reference interval and biological variability were also assessed. Measurable samples were compared between ARCHITECT instruments and between the routine and STAT assays and also to a galectin-3 ELISA (BG Medicine).


RESULTS
The total assay coefficient of variation (CV%) was 2.3%-6.2% and 1.7%-7.4% for the routine and STAT assays, respectively. Both assays demonstrated linearity up to 120 ng/mL. Galectin-3 concentrations were higher in plasma samples than in serum samples and correlated well between fresh and frozen samples (R=0.997), between the routine and STAT assays, between the ARCHITECT i1000 and i2000 instruments and with the galectin-3 ELISA. The reference interval on 627 apparently healthy individuals (53% male) yielded upper 95th and 97.5th percentiles of 25.2 and 28.4 ng/mL, respectively. Values were significantly lower in subjects younger than 50 years.


CONCLUSIONS
The galectin-3 routine and STAT assays on the Abbott ARCHITECT instruments demonstrated good analytical performance. Further clinical studies are required to demonstrate the diagnostic and prognostic potential of this novel marker in patients with CHF.
David C
DC
Gaze
Christian
C
Prante
Jens
J
Dreier
Cornelius
C
Knabbe
Corinne
C
Collet
Jean-Marie
JM
Launay
Janka
J
Franekova
Antonin
A
Jabor
Lieselotte
L
Lennartz
Jessie
J
Shih
Jose Manuel
JM
del Rey
Martina
M
Zaninotto
Mario
M
Plebani
Paul O
PO
Collinson
D001331:Automation; D001774:Blood Chemical Analysis / Q000295:instrumentation* / Q000592:standards; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation* / Q000592:standards; D037502:Galectin 3 / Q000097:blood*; D006801:Humans; D057230:Limit of Detection; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D013997:Time Factors
D037502:Galectin 3