We conducted a multicenter evaluation of the analytical and clinical performance of the automated Bayer Immuno 1™ complexed PSA (cPSA) assay, and compared assay performance to the Bayer Immuno 1™ PSA assay. We sought to determine whether measurements of cPSA could be of clinical utility in the management of patients with prostate cancer. Results of the 10–day imprecision across three evaluation sites produced total CV < 2.50% and an analytical sensitivity of 0.02μg/L. There was an increased trend in clinical sensitivity for prostate cancer with increasing stage of disease (71–86%). Clinical specificity for patients with benign urogenital disease was 74.8%, and for other nonprostate diseases ranged from 91.1–100%. Retrospective serial monitoring of 155 patients with prostate cancer demonstrated concordance of cPSA measurements to clinical status for 97% of the patients analyzed. Results from the clinical studies using the Bayer Immuno 1 cPSA assay were comparable to results obtained with the Bayer Immuno 1 PSA assay. The Bayer Immuno 1 cPSA assay demonstrates analytical performance and clinical effectiveness in the management of prostate cancer patients during the course of disease and therapy.
OesterlingJ.E.Prostate specific antigen: a critical assessment of the most useful tumor marker for adenocarcinoma of the prostate.J Urol1991; 145: 907–23.
2.
PartinA.W., OesterlingJ.E.The clinical usefulness of prostate specific antigen: update 1994 [Review].J Urol1994; 152: 1358–68.
3.
LiljaH., ChristenssonA., MatikainenM-T, NilssonO., PetterssonK., LovgrenT.Prostate-specific antigen in human serum occurs predominantly in complex with alpha-1-antichymotrypsin.Clin Chem1991; 37: 1618–25.
4.
StenmanU.H., LeinonenJ., AlfthanH., RannikkoS., TuhkanenK., AlfthanO.A complex between prostate-specific antigen and alpha-1-antichymotrypsin is the major form of prostate-specific antigen in serum of patients with prostatic cancer: Assay of the complex improves clinical sensitivity for cancer.Cancer Res1991; 51: 222–6.
5.
ChristenssonA., BjorkT., NilssonO.Serum prostate specific antigen complexed with alpha-1 antichymotrypsin as an indicator of prostate cancer.J Urol1993; 150: 100–5.
6.
CatalonaW.J., SmithD.S., WolfertR.L.Evaluation of percent free serum prostate-specific antigen to improve specificity in prostate cancer screening.JAMA1995; 274: 1214–20.
7.
CatalonaW.J., PartinA.W., SlawinK.M.Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease.JAMA1998; 279(3): 1542–7.
8.
ChanD.W., SokollL.J., JonesK.A., KelleyC.A., SubongE.N.P., PartinA.W.Clinical evaluation of two free PSA assays in combination with different total PSA assays.J Urol1997; 157(Suppl): 112.
9.
FortunataA., DorizziR.M., MarchiG., CoccoC., DaviniA.fPSA/total PSA ratios obtained using nine commercial assays.Clin Chem1996; 42(Suppl): 268.
10.
AllardW.J., ZhouZ., YeungK.K.Novel immunoassay for the measurement of complexed prostate-specific antigen in serum.Clin Chem1998; 44 (6): 1216–23.
11.
BrawerM.K., MeyerG.E., LetranJ.L.Measurement of complexed PSA improves specificity for early detection of prostate cancer.Urology1998; 52(3): 372–8.
12.
StenmanU-H, PausE., SequinP.Summary of the TD-3 workshop for characterization of monoclonal antibodies (Mabs) to prostate specific antigen (PSA). (manuscript in preparation)
13.
ZhouZ., NgP.C., VeryD.L., AllardW.J., YeungK.K.Technicon Immuno 1™ PSA assay measures both free and α-1-antichymotrypsin complexed prostate-specific antigen on an equimolar basis.J Clin Lab Anal1996; 10: 155–9.
14.
ZhouZ., ArmstrongE.G., BelenkyA., FreemanJ.V., YeungK.K.Equvalent recognition of free and ACT-complexed PSA in a monoclonal polyclonal sandwich assay is conferred by binding specificity of the monoclonal antibody.J Clin Lab Anal1998; 12: 242–9.
15.
MorrisD.L., DillionP.W., VeryD.L.Bayer Immuno 1™ PSA assay: an automated, ultrasensitive method to quantitate total PSA in serum.J Clin Lab Anal1998; 12: 65–74.
16.
American Joint Committee on Cancer.Manual for staging of cancer.5th Edition.Philadelphia, PA: J.B. Lippincott Company1997; 219–22.
17.
VessellaR.L., LangeP.H.Issues in the assessment of PSA immunoassays.Urol Clin North Am1993; 20(4): 607–19.
18.
WuJ.T., ZhangP., LiuG.H., WilsonL.Development of an immunoassay specific for the PSA-ACT complex without the problem of high background.J Clin Lab Anal1998; 12: 14–9.
19.
EspanaF., MartinezM., RoyoM.Reference ranges for the concentrations of total and complexed plasma prostate-specific antigen and their ratios in patients with benign prostate hyperplasia.Eur Urol1997; 32: 268–72.
20.
LangeP.H., ErcoleC.J., LightnerD.J., FraleyE.E., VessellaR.The value of prostate specific antigen determinations before and after radical prostatectomy.J Urol1989; 141: 873–9.
21.
LichtnerD.J., LangeP.H., ReddyP.K., MooreL.Prostate specific antigen and local recurrence after radical prostatectomy.J Urol1990; 144: 873–9.
22.
TakayamaT.K., VessellaR.L., BrawerM.K., NoteboomJ., LangeP.H.The enhanced detection of persisitent disease after prostatectomy with a new prostate specific antigen immunoassay.J Urol1993; 150: 374–8.
23.
PausE., NilssonO., BormerO.P.Stability of free and total prostate specific antigen in serum from patients with prostate carcinoma and benign hyperplasia.J Urol1998; 159: 1599–605.
24.
WoodrumD., FrenchC., ShamelL.B.Stability of free prostate-specific antigen in serum samples under a variety of sample collection and storage conditions.Urology1996; 48(6A): 33–9.
25.
JungK., vonKlinggraff, BruxB., SinhaP., SchnorrD., LoeningS.A.Preanalytical determinants of total and free prostate specific antigen and their ratio: blood collection and storage conditions.Clin Chem1998; 44(3): 685–8.
26.
PiironenT., PetterssonK., SuonpaaM.In vitro stability of free prostate-specific antigen (PSA) and prostate-specific antigen (PSA) complexed to alpha 1-antichymotrypsin in blood samples.Urology1996; 48(6A Suppl): 81–7.
27.
BrawerM.K., FerreriL.F., BanksonD.D.Long-term stability of complex prostate specific antigen (PSA) in frozen serum.J Urol1999; 161(Suppl): 318.
28.
KuriyamaM., UenoK., UnoH.Clinical evaluation of serum prostate-specific antigen-alpha1-antichymotrypsin complex values in diagnosis of prostate cancer: a cooperative study.Int J Urol1998; 5(1): 48–54.
29.
LernerS.E., JacobsenS.J., LiljaH.Free, complexed, and total serum prostate-specific antigen concentrations and their proportions in predicting stage, grade, and deoxyribonucleic acid ploidy in patients with adenocarcinoma of the prostate.Urology1996; 48: 240–8.
30.
HudsonM.A., BahnsonR.R., CatalonaW.J.Clinical use of prostate specific antigen in patients with prostate cancer.J Urol1989; 142: 1011–7.
31.
OesterlingJ.E., ChanD.W., EpsteinJ.I.Prostate specific antigen in preoperative and postoperative evaluation of localized prostatic cancer treated with radical prostatectomy.J Urol1991; 145: 907–23.
32.
OesterlingJ.E., ChuteC.G., JacobsenS.J.Serum prostate-specific antigen in a community-based population of healthy men. Establishment of age-specific reference ranges.JAMA1993; 270: 860.
33.
OesterlingJ.E., JacobsenS.J., KleeG.G.Free, complexed and total serum prostate-specific antigen: the establishment of appropriate reference ranges for their concentrations and ratios.J Urol1995; 154: 1090–5.
34.
CatalonaW.J., HudsonM.A., ScardinoP.T.Selection of optimal prostate specific antigen cutoffs for early detection of prostate cancer: receiver operating characteristics curves.J Urol1994; 152: 2037–42.
35.
StameyT.A., DonaldsonA.N., YemotoC.E., McNealJ.E., SozenS., GillH.Histological and clinical findings in 896 consecutive prostates treated only by radical retropubic prostatectomy: epidemiologic significance of annual changes.J Urol1998; 160(6 pt 2): 2412–7.
36.
LangeP.H.Prostate specific antigen in diagnosis and management of prostate cancer.Urology1990; 36(5): 25–9.
37.
WuJ.T., WilsonL., ZhangP., MeikleW.A., StephensonR.A.Correlation of serum concentrations of PSA-ACT complex with total PSA in random and serial specimens from patients with BPH and prostate cancer.J Clin Lab Anal1995; 9: 15–20.
38.
WuJ.T., LiuG.H.Advantages of replacing the total PSA assay with the assay for PSA-α1-antichymotrypsin complex for the screening and management of prostate cancer.J Clin Lab Anal1998; 12: 32–40.
39.
PetterssonK., PirronenT., SeppallaM.Free and complexed prostate-specific antigen: in vitro stability, epitope map, and development of immunofluorometric assays for specific and sensitive detection of free PSA and PSA α-1-antichymotrypsin complex.Clin Chem1995; 41(10): 1480–8.
ChenZ., ChenH., StameyT.A.Monoclonal antibodies 2F5 and 4G10 against prostate specific antigen (PSA) complexed to α1-antichymotrypsin.J Urol1998; 160: 870–5.
42.
JungK., BruxB., KnabichA.A gap between total prostate-specific antigen and the sum of free prostate-specific antigen plus α1-antichymotrypsin-specific-prostate-specific antigen in patients with prostate carcinoma but not in those with benign prostate hyperplasia.Clin Chem1999; 45(3): 422–4.
