Rapid one-step assay for prostate specific antigen in whole blood using an optical immunoassay technology

1995 ◽  
Author(s):  
Grenville Robinson ◽  
Timothy Bacarese-Hamilton ◽  
Paul M. O'Neill ◽  
Janys E. Fletcher ◽  
Phelim B. Daniels ◽  
...  
2002 ◽  
Vol 48 (8) ◽  
pp. 1272-1278 ◽  
Author(s):  
Barbara R Grzeda ◽  
Tuan Le Bui ◽  
Cheryl N Warner ◽  
Tracy L Pirucki ◽  
Lisa M Dewey ◽  
...  

Abstract Background: Prostate-specific antigen (PSA) is widely used in the detection and monitoring of prostate cancer. We developed a system for the self-collection and transport of capillary whole blood for PSA analysis, with the goal of reducing phlebotomy visits and, thus, increasing the access and utilization of PSA in prostate cancer screening and monitoring. Methods: The blood collection device [BIOSAFE Blood Transport System (BTSTM)] collects 70 μL of blood through a heparin-coated material into 200 μL of stabilizing solution. The diluted whole blood is used for measurement of PSA by a modified version of the Hybritech® Tandem-MP PSA Assay. Results were compared for matched samples of professionally and self-collected BTS blood and for matched BTS samples sera from blood collected by venipuncture. Imprecision for the whole-blood PSA measurement was estimated from analysis of whole-blood controls in duplicate, twice per day, over 20 days. Results: BTS samples (n = 140) collected by a qualified healthcare professional compared with serum samples yielded the regression equation: y =1.02x + 0.04 (Sy|x = 0.35; r = 0.99). Comparison of the results for samples (n = 128) collected by the patient without professional assistance with serum samples yielded: y = 1.08x + 0.02 (Sy|x = 0.31; r = 0.99). The between-run CVs at 0.069, 0.53, 2.9, and 10.7 μg/L were 21%, 6.0%, 3.5%, and 3.8%, respectively. PSA was stable in BTS samples stored for 21 days at 18–24 °C and for 7 days at 37 °C. Conclusion: The BIOSAFE BTS system allows accurate and convenient measurement of circulating PSA by a precise method for diluted whole blood.


2005 ◽  
Vol 307 (1-2) ◽  
pp. 1-12 ◽  
Author(s):  
César Fernández-Sánchez ◽  
Calum J. McNeil ◽  
Keith Rawson ◽  
Olle Nilsson ◽  
Hing Y. Leung ◽  
...  

1996 ◽  
Vol 42 (4) ◽  
pp. 536-544 ◽  
Author(s):  
B R Hoffman ◽  
H Yu ◽  
E P Diamandis

Abstract We report the measure of prostate-specific antigen (PSA) from extracts of blood dried on filter paper. Five 3-mm (diameter) paper discs containing approximately 25 microL of dried whole blood were punched from the filter paper and extracted with 500 microL of buffer. Recovery of PSA was > 92%. Imprecision of the filter paper procedure was <10% when corresponding whole-blood concentrations were >0.35 micrograms/L. PSA recovery was unaffected whether blood was applied to the filter as one 85-microL aliquots, two 43-microL aliquots, or three 28-microL aliquots. PSA is contained in the plasma fraction. Variation in hematocrit from 0.61 to 0.31 caused <+/-10% change in filter paper PSA. Regression analysis showed: filter paper PSA = 0.86 whole-blood PSA - 0.02; Sy/x = 0.44. Men (153) without prostate cancer gave a 95th percentile of 4.8 micrograms /L. PSA in filter paper dried blood was stable for >1 month at -20 to 37 degrees C and showed no loss of recovery after being mailed to a hot climate. We conclude that the filter paper procedure can reliably distinguish normal from increased concentrations of PSA and that it could facilitate screening to detect occult prostate cancer in large-scale mail-in programs to centralized laboratories.


1995 ◽  
Vol 41 (8) ◽  
pp. 1115-1120 ◽  
Author(s):  
K Mitrunen ◽  
K Pettersson ◽  
T Piironen ◽  
T Björk ◽  
H Lilja ◽  
...  

Abstract We developed a simple one-step dual-label immunoassay for simultaneous measurement of the free, noncomplexed form of prostate-specific antigen (PSA) and total PSA. The assay is based on time-resolved fluorescence and includes a stable fluorescent chelate of Eu to label a monoclonal antibody (mAb) that detects only free PSA, whereas a second mAb labeled with a fluorescent chelate of Tb provides equimolar detection of both free PSA and PSA complexed to alpha 1-antichymotrypsin. A third mAb on a solid phase captures the free and complexed forms of PSA in an equimolar fashion. The simultaneous measurement of the free-to-total PSA ratio (F/T) with the one-step dual assay is not sensitive to variations in the sample volume. The discrimination between benign prostatic hyperplasia and prostate cancer patients, i.e., the area under the receiver-operating characteristic curve, increased from 0.64 (total PSA assay) to 0.78 and 0.81 when the F/T ratio was measured with single and dual assays, respectively.


2009 ◽  
Vol 81 (15) ◽  
pp. 6030-6037 ◽  
Author(s):  
Andreas Lenshof ◽  
Asilah Ahmad-Tajudin ◽  
Kerstin Järås ◽  
Ann-Margret Swärd-Nilsson ◽  
Lena Åberg ◽  
...  

1988 ◽  
Vol 34 (10) ◽  
pp. 2175-2177 ◽  
Author(s):  
H C Vaidya ◽  
B A Wolf ◽  
N Garrett ◽  
W J Catalona ◽  
R V Clayman ◽  
...  

Abstract We reviewed 721 consecutive samples submitted for measurement of prostate-specific antigen (PSA) over five months. We identified three patients with extremely high PSA concentrations: 650, 1840, and 3280 micrograms/L (their acid phosphatase activities were 3.2, 1337, and 2.8 U/L, respectively), and present case reports for the latter two. Serial dilutions of samples obtained from the patient with the highest PSA concentration indicated that the one-step Tandem-PSA assay gave falsely low values for high concentrations of PSA, an observation consistent with the phenomenon of the "hook effect." This effect was not observed when the sample was reanalyzed for PSA by a two-step procedure.


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