Development and analytical performance evaluation of an automated chemiluminescent immunoassay for pro-gastrin releasing peptide (ProGRP).
BACKGROUND
Pro-gastrin releasing peptide (ProGRP) concentrations in blood play an important role in the diagnosis and treatment of patients with small cell lung cancer (SCLC). The automated quantitative ARCHITECT ProGRP assay was developed to aid in the differential diagnosis and in the management of SCLC. The purpose of this study was to evaluate the analytical performance of this chemiluminescent microparticle immunoassay at multiple sites.


METHODS
ARCHITECT ProGRP measures ProGRP using a two-step sandwich using monoclonal anti-ProGRP antibodies coated on paramagnetic microparticles and labeled with acridinium. Analytical performance of the assay was evaluated at four sites: Abbott Japan, Denka Seiken, the Johns Hopkins University, and the University of Munich.


RESULTS
Total precision (%CV) for nine analyte concentrations was between 2.2 and 5.7. The analytical sensitivity of the assay was between 0.20 pg/mL and 0.88 pg/mL. The functional sensitivity at 20% CV was between 0.66 pg/mL and 1.73 pg/mL. The assay was linear up to 50,000 pg/mL using a 1:10 autodilution protocol. The calibration curve was stable for 30 days. Comparison with the Fujirebio microtiter plate enzyme-linked immunosorbent assay (EIA) ProGRP assay gave a slope of 0.93 and a correlation coefficient (r) of 0.99.


CONCLUSIONS
These results demonstrate that the ARCHITECT ProGRP assay has excellent sensitivity, precision, and correlation to a reference method. This assay provides a convenient automated method for ProGRP measurement in serum and plasma in hospitals and clinical laboratories.
Yoshimura
Toru
T
Diagnostics Division, Abbott Japan, Matsudo-City, Chiba, Japan.
Fujita
Kenju
K
Kinukawa
Hideki
H
Matsuoka
Yoshiharu
Y
Patil
Rahul D
RD
Beligere
Gangamani S
GS
Chan
Sabrina S
SS
Dowell
Barry L
BL
Sokoll
Lori
L
Elliott
Debra
D
Chan
Daniel W
DW
Scheuer
Cornelia
C
Hofmann
Karin
K
Stieber
Petra
P
Sakurai
Yousuke
Y
Iizuka
Masayuki
M
Saegusa
Haruhisa
H
Yamaguchi
Ken
K
D000911:Antibodies, Monoclonal / Q000276:immunology; D018288:Carcinoma, Small Cell / Q000097:blood* / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D049449:Luminescence; D008175:Lung Neoplasms / Q000097:blood* / Q000175:diagnosis / Q000628:therapy; D010446:Peptide Fragments / Q000097:blood* / Q000276:immunology; D011994:Recombinant Proteins / Q000097:blood / Q000276:immunology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000911:Antibodies, Monoclonal; D010446:Peptide Fragments; D011994:Recombinant Proteins; C087079:pro-gastrin-releasing peptide (31-98)