Analytical performance of the Tandem-R free PSA immunoassay measuring free prostate-specific antigen.
The analytical performance of the Tandem-R free PSA assay available from Hybritech Inc. was evaluated. Comparison of recoveries of purified free (unbound) prostate-specific antigen (PSA) diluted in female serum in the Tandem-R free PSA assay and the Tandem-R (total) PSA assay demonstrated a link in calibration between the assays and an accurate determination of percent free PSA. The cross-reactivity of the assay to purified PSA-alpha 1-antichymotrypsin was determined to be < 1%. The minimum-detectable concentration was < 0.05 microgram/L. The within-run and between-day CVs were < or = 5% for samples with > 0.3 microgram/L free PSA. Dilution and recovery showed no significant deviations from linearity across the assay range. The assay was insensitive to interference from blood components. The Tandem-R free PSA kit was shown to be an accurate, precise, and reliable assay for the measurement of free PSA.
Woodrum
D L
DL
Department of Research and Development, Hybritech Inc., San Diego, CA 92196, USA. dlwoodrum@beckman.com
French
C M
CM
Hill
T M
TM
Roman
S J
SJ
Slatore
H L
HL
Shaffer
J L
JL
York
L G
LG
Eure
K L
KL
Loveland
K G
KG
Gasior
G H
GH
Southwick
P C
PC
Shamel
L B
LB
D002138:Calibration; D005260:Female; D006801:Humans; D015592:Immunoradiometric Assay / Q000379:methods* / Q000706:statistics & numerical data; D017430:Prostate-Specific Antigen / Q000097:blood*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D000514:alpha 1-Antichymotrypsin / Q000097:blood
D011933:Reagent Kits, Diagnostic; D000514:alpha 1-Antichymotrypsin; D017430:Prostate-Specific Antigen