메뉴 건너뛰기




Volumn 46, Issue 5, 2008, Pages 623-629

Toward metrological traceability in the determination of prostate-specific antigen (PSA): Calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards

Author keywords

Method comparison; Metrological traceability; Prostate cancer; Prostate specific antigen (PSA); WHO PSA standards

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

EID: 44349125832     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/CCLM.2008.129     Document Type: Article
Times cited : (25)

References (34)
  • 1
    • 0030451178 scopus 로고    scopus 로고
    • Comparison of three assays for total serum prostate-specific antigen and percentage of free prostate-specific antigen in predicting prostate histology
    • Roehrborn CG, Gregory A, McConnell JD, Sagalowsky AI, Wians FH. Comparison of three assays for total serum prostate-specific antigen and percentage of free prostate-specific antigen in predicting prostate histology. Urology 1996;48:23-32.
    • (1996) Urology , vol.48 , pp. 23-32
    • Roehrborn, C.G.1    Gregory, A.2    McConnell, J.D.3    Sagalowsky, A.I.4    Wians, F.H.5
  • 2
    • 0032323053 scopus 로고    scopus 로고
    • Comparison of 3 investigational assays for the free form of prostate specific antigen
    • Nixon RG, Meyer GE, Blase AB, Gold MH, Brawer MK. Comparison of 3 investigational assays for the free form of prostate specific antigen. J Urol 1998;160:420-5.
    • (1998) J Urol , vol.160 , pp. 420-425
    • Nixon, R.G.1    Meyer, G.E.2    Blase, A.B.3    Gold, M.H.4    Brawer, M.K.5
  • 3
    • 0032167801 scopus 로고    scopus 로고
    • Comparability of serum prostate-specific antigen measurement between the Hybritech Tandem-R and Abbott AxSYM assays
    • Leewansangtong S, Goktas S, Lepoff R, Holthaus K, Crawford ED. Comparability of serum prostate-specific antigen measurement between the Hybritech Tandem-R and Abbott AxSYM assays. Urology 1998;52:467-9.
    • (1998) Urology , vol.52 , pp. 467-469
    • Leewansangtong, S.1    Goktas, S.2    Lepoff, R.3    Holthaus, K.4    Crawford, E.D.5
  • 4
    • 0034125518 scopus 로고    scopus 로고
    • A comparison of six commercial assays for total and free prostate specific antigen (PSA): The predictive value of the ratio of free to total PSA
    • Patel D, White PA, Milford WA. A comparison of six commercial assays for total and free prostate specific antigen (PSA): the predictive value of the ratio of free to total PSA. BJU Int 2000;85:686-9.
    • (2000) BJU Int , vol.85 , pp. 686-689
    • Patel, D.1    White, P.A.2    Milford, W.A.3
  • 6
    • 0035729131 scopus 로고    scopus 로고
    • Discordant performance of assays for free and total prostate-specific antigen in relation to the early detection of prostate cancer
    • Blijenberg BG, Yurdakul G, Van Zelst BD, Bangma CH, Wildhagen MF, Schroder FH. Discordant performance of assays for free and total prostate-specific antigen in relation to the early detection of prostate cancer. BJU Int 2001;88:545-50.
    • (2001) BJU Int , vol.88 , pp. 545-550
    • Blijenberg, B.G.1    Yurdakul, G.2    Van Zelst, B.D.3    Bangma, C.H.4    Wildhagen, M.F.5    Schroder, F.H.6
  • 7
    • 2442526439 scopus 로고    scopus 로고
    • Variation in prostate specific antigen results from 2 different assay platforms: Clinical impact on 2304 patients undergoing prostate cancer screening
    • Link RE, Shariat SF, Nguyen CV, Farr A, Weinberg AD, Morton RA, et al. Variation in prostate specific antigen results from 2 different assay platforms: clinical impact on 2304 patients undergoing prostate cancer screening. J Urol 2004;171:2234-8.
    • (2004) J Urol , vol.171 , pp. 2234-2238
    • Link, R.E.1    Shariat, S.F.2    Nguyen, C.V.3    Farr, A.4    Weinberg, A.D.5    Morton, R.A.6
  • 8
    • 29744462375 scopus 로고    scopus 로고
    • Interchangeability of measurements of total and free prostate-specific antigen in serum with 5 frequently used assay combinations: An update
    • Stephan C, Klaas M, Müller C, Schnorr D, Loening SA, Jung K. Interchangeability of measurements of total and free prostate-specific antigen in serum with 5 frequently used assay combinations: an update. Clin Chem 2006;52:59-64.
    • (2006) Clin Chem , vol.52 , pp. 59-64
    • Stephan, C.1    Klaas, M.2    Müller, C.3    Schnorr, D.4    Loening, S.A.5    Jung, K.6
  • 9
    • 33746633333 scopus 로고    scopus 로고
    • Comparison of 6 automated assays for total and free prostate-specific antigen with special reference to their reactivity toward the WHO 96/670 reference preparation
    • Kort SA, Martens F, Vanpoucke H, Van Duijnhoven HL, Blankenstein MA. Comparison of 6 automated assays for total and free prostate-specific antigen with special reference to their reactivity toward the WHO 96/670 reference preparation. Clin Chem 2006;52:1568-74.
    • (2006) Clin Chem , vol.52 , pp. 1568-1574
    • Kort, S.A.1    Martens, F.2    Vanpoucke, H.3    Van Duijnhoven, H.L.4    Blankenstein, M.A.5
  • 10
    • 0029240414 scopus 로고    scopus 로고
    • Stamey TA. Second Stanford Conference on International Standardization of Prostate-Specific Antigen Immunoassays: September 1 and 2, 1994. Urology 1995;45:173-84.
    • Stamey TA. Second Stanford Conference on International Standardization of Prostate-Specific Antigen Immunoassays: September 1 and 2, 1994. Urology 1995;45:173-84.
  • 13
    • 34248157327 scopus 로고    scopus 로고
    • Improving the comparability of immunoassays for prostate-specific antigen (PSA): Progress and problems
    • Sturgeon CM, Ellis AR. Improving the comparability of immunoassays for prostate-specific antigen (PSA): progress and problems. Clin Chim Acta 2007;381:85-92.
    • (2007) Clin Chim Acta , vol.381 , pp. 85-92
    • Sturgeon, C.M.1    Ellis, A.R.2
  • 15
    • 34249998946 scopus 로고    scopus 로고
    • Assay standardization bias: Different prostate cancer detection rates and clinical outcomes resulting from different assays for free and total prostate-specific antigen
    • Sotelo RJ, Mora KE, Perez LH, Novoa J, Carmona O, De AR, et al. Assay standardization bias: different prostate cancer detection rates and clinical outcomes resulting from different assays for free and total prostate-specific antigen. Urology 2007;69:1143-6.
    • (2007) Urology , vol.69 , pp. 1143-1146
    • Sotelo, R.J.1    Mora, K.E.2    Perez, L.H.3    Novoa, J.4    Carmona, O.5    De, A.R.6
  • 16
    • 44349096990 scopus 로고    scopus 로고
    • Metrological traceability and its implementation; a report
    • Clinical and Laboratory Standards Institute, Clinical and Laboratory Standards Institute: Wayne, PA, USA
    • Clinical and Laboratory Standards Institute. Metrological traceability and its implementation; a report. CLSI document X5-R. Clinical and Laboratory Standards Institute: Wayne, PA, USA, 2006:1-43.
    • (2006) CLSI document X5-R , pp. 1-43
  • 17
    • 44349178752 scopus 로고    scopus 로고
    • Traceability, reference systems and result comparability
    • Panteghini M. Traceability, reference systems and result comparability. Clin Biochem Rev 2007;28:97-104.
    • (2007) Clin Biochem Rev , vol.28 , pp. 97-104
    • Panteghini, M.1
  • 18
    • 0027244140 scopus 로고
    • Serum prostate-specific antigen in a community-based population of healthy men: Establishment of age-specific reference ranges
    • Oesterling JE, Jacobsen SJ, Chute CG. Serum prostate-specific antigen in a community-based population of healthy men: establishment of age-specific reference ranges. J Am Med Assoc 1993;270:860-4.
    • (1993) J Am Med Assoc , vol.270 , pp. 860-864
    • Oesterling, J.E.1    Jacobsen, S.J.2    Chute, C.G.3
  • 19
    • 0027938330 scopus 로고
    • Selection of optimal prostate specific antigen cutoffs for early detection of prostate cancer: Receiver operating characteristic curves
    • Catalona WJ, Hudson MA, Scardino PT, Richie JP, Ahmann FR, Flanigan RC, et al. Selection of optimal prostate specific antigen cutoffs for early detection of prostate cancer: receiver operating characteristic curves. J Urol 1994;152:2037-42.
    • (1994) J Urol , vol.152 , pp. 2037-2042
    • Catalona, W.J.1    Hudson, M.A.2    Scardino, P.T.3    Richie, J.P.4    Ahmann, F.R.5    Flanigan, R.C.6
  • 20
    • 0021045350 scopus 로고
    • A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, part I
    • Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, part I. J Clin Chem Clin Biochem 1983;21:709-20.
    • (1983) J Clin Chem Clin Biochem , vol.21 , pp. 709-720
    • Passing, H.1    Bablok, W.2
  • 21
    • 0032884749 scopus 로고    scopus 로고
    • Measuring agreement in method comparison studies
    • Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999;8:135-60.
    • (1999) Stat Methods Med Res , vol.8 , pp. 135-160
    • Bland, J.M.1    Altman, D.G.2
  • 22
    • 0029008314 scopus 로고
    • Software for illustrative presentation of basic clinical characteristics of laboratory tests - GraphROC for Windows
    • Kairisto V, Poola A. Software for illustrative presentation of basic clinical characteristics of laboratory tests - GraphROC for Windows. Scand J Clin Lab Invest 1995;55(Suppl 222):43-60.
    • (1995) Scand J Clin Lab Invest , vol.55 , Issue.SUPPL. 222 , pp. 43-60
    • Kairisto, V.1    Poola, A.2
  • 23
    • 0035148622 scopus 로고    scopus 로고
    • Hybritech total and free prostate-specific antigen assays developed for the Beckman Coulter access automated chemiluminescent immunoassay system: A multicenter evaluation of analytical performance
    • Laffin RJ, Chan DW, Tanasijevic MJ, Fischer GA, Markus W, Miller J, et al. Hybritech total and free prostate-specific antigen assays developed for the Beckman Coulter access automated chemiluminescent immunoassay system: a multicenter evaluation of analytical performance. Clin Chem 2001;47:129-32.
    • (2001) Clin Chem , vol.47 , pp. 129-132
    • Laffin, R.J.1    Chan, D.W.2    Tanasijevic, M.J.3    Fischer, G.A.4    Markus, W.5    Miller, J.6
  • 24
    • 0347756698 scopus 로고    scopus 로고
    • Quality assessment for prostate-specific antigen (PSA) in relation to ERSPC: Report of the PSA committee
    • Blijenberg BG, Lilja H, Neels H, Stenman UH. Quality assessment for prostate-specific antigen (PSA) in relation to ERSPC: report of the PSA committee. BJU Int 2003;92(Suppl 2):66-70.
    • (2003) BJU Int , vol.92 , Issue.SUPPL. 2 , pp. 66-70
    • Blijenberg, B.G.1    Lilja, H.2    Neels, H.3    Stenman, U.H.4
  • 25
    • 30844455114 scopus 로고    scopus 로고
    • Prostate-specific antigen: Bias and molarity of commercial assays for PSA in use in England
    • Roddam AW, Rimmer J, Nickerson C, Ward AM. Prostate-specific antigen: bias and molarity of commercial assays for PSA in use in England. Ann Clin Biochem 2006;43:35-48.
    • (2006) Ann Clin Biochem , vol.43 , pp. 35-48
    • Roddam, A.W.1    Rimmer, J.2    Nickerson, C.3    Ward, A.M.4
  • 26
    • 34447325342 scopus 로고    scopus 로고
    • Interchangeability and diagnostic accuracy of two assays for total and free prostate-specific antigen: Two not always related items
    • Dittadi R, Franceschini R, Fortunato A, Zancan M, Barichello M, Tasca A, et al. Interchangeability and diagnostic accuracy of two assays for total and free prostate-specific antigen: two not always related items. Int J Biol Markers 2007;22:154-8.
    • (2007) Int J Biol Markers , vol.22 , pp. 154-158
    • Dittadi, R.1    Franceschini, R.2    Fortunato, A.3    Zancan, M.4    Barichello, M.5    Tasca, A.6
  • 27
    • 0028787253 scopus 로고
    • Identity of PSA purified from seminal fluid by different methods: Comparison by amino acid analysis and assigned extinction coefficients
    • Stamey TA, Teplow DB, Graves HC. Identity of PSA purified from seminal fluid by different methods: comparison by amino acid analysis and assigned extinction coefficients. Prostate 1995;27:198-203.
    • (1995) Prostate , vol.27 , pp. 198-203
    • Stamey, T.A.1    Teplow, D.B.2    Graves, H.C.3
  • 28
    • 0028865871 scopus 로고
    • Molecular mass and carbohydrate structure of prostate specific antigen: Studies for establishment of an international PSA standard
    • Belanger A, Vanhalbeek H, Graves HC, Grandbois K, Stamey TA, Huang LH, et al. Molecular mass and carbohydrate structure of prostate specific antigen: studies for establishment of an international PSA standard. Prostate 1995;27:187-97.
    • (1995) Prostate , vol.27 , pp. 187-197
    • Belanger, A.1    Vanhalbeek, H.2    Graves, H.C.3    Grandbois, K.4    Stamey, T.A.5    Huang, L.H.6
  • 29
    • 0025609492 scopus 로고
    • Identity of prostate specific antigen and the semen protein P30 purified by a rapid chromatography technique
    • Graves HC, Kamarei M, Stamey TA. Identity of prostate specific antigen and the semen protein P30 purified by a rapid chromatography technique. J Urol 1990;144:1510-5.
    • (1990) J Urol , vol.144 , pp. 1510-1515
    • Graves, H.C.1    Kamarei, M.2    Stamey, T.A.3
  • 30
    • 44349083162 scopus 로고    scopus 로고
    • Stephan C, Semjonow A. Accuracy assessment of PSA methods must be based on clinical instead of artificial samples - a response to AW Roddam et al., Ann Clin Biochem 2006;43:35-48. Ann Clin Biochem 2006;43:421-2.
    • Stephan C, Semjonow A. Accuracy assessment of PSA methods must be based on clinical instead of artificial samples - a response to AW Roddam et al., Ann Clin Biochem 2006;43:35-48. Ann Clin Biochem 2006;43:421-2.
  • 31
    • 14844297075 scopus 로고    scopus 로고
    • Comparison of fresh frozen serum to proficiency testing material in College of American Pathologists surveys: Alpha-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin, and prostate-specific antigen
    • Schreiber WE, Endres DB, McDowell GA, Palomaki GE, Elin RJ, Klee GG, et al. Comparison of fresh frozen serum to proficiency testing material in College of American Pathologists surveys: alpha-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin, and prostate-specific antigen. Arch Pathol Lab Med 2005;129:331-7.
    • (2005) Arch Pathol Lab Med , vol.129 , pp. 331-337
    • Schreiber, W.E.1    Endres, D.B.2    McDowell, G.A.3    Palomaki, G.E.4    Elin, R.J.5    Klee, G.G.6
  • 32
    • 2642574977 scopus 로고    scopus 로고
    • Assessing the clinical impact of prostate-specific antigen assay variability and nonequimolarity: A simulation study based on the population of the United Kingdom
    • Roddam AW, Price CP, Allen NE, Ward AM. Assessing the clinical impact of prostate-specific antigen assay variability and nonequimolarity: a simulation study based on the population of the United Kingdom. Clin Chem 2004;50:1012-6.
    • (2004) Clin Chem , vol.50 , pp. 1012-1016
    • Roddam, A.W.1    Price, C.P.2    Allen, N.E.3    Ward, A.M.4
  • 33
    • 34447310064 scopus 로고    scopus 로고
    • Different prostate-specific antigen assays give different results on the same blood sample: An obstacle to recommending uniform limits for prostate biopsies
    • Stephan C, Kramer J, Meyer HA, Kristiansen G, Ziemer S, Deger S, et al. Different prostate-specific antigen assays give different results on the same blood sample: an obstacle to recommending uniform limits for prostate biopsies. BJU Int 2007;99:1427-31.
    • (2007) BJU Int , vol.99 , pp. 1427-1431
    • Stephan, C.1    Kramer, J.2    Meyer, H.A.3    Kristiansen, G.4    Ziemer, S.5    Deger, S.6
  • 34
    • 36048955792 scopus 로고    scopus 로고
    • Five-year stability study of free and total prostate-specific antigen concentrations in serum specimens collected and stored at -70°C or less
    • Scaramuzzino DA, Schulte K, Mack BN, Soriano TF, Fritsche HA. Five-year stability study of free and total prostate-specific antigen concentrations in serum specimens collected and stored at -70°C or less. Int J Biol Markers 2007;22:206-13.
    • (2007) Int J Biol Markers , vol.22 , pp. 206-213
    • Scaramuzzino, D.A.1    Schulte, K.2    Mack, B.N.3    Soriano, T.F.4    Fritsche, H.A.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.