Fifth-generation digital immunoassay for prostate-specific antigen by single molecule array technology

Clinical Chemistry

Volumn 57, Issue 12, 2011, Pages 1712-1721

  Wilson, David H ^a   Hanlon, David W ^a   Provuncher, Gail K ^a   Chang, Lei ^a   Song, Linan ^a   Patel, Purvish P ^a   Ferrell, Evan P ^a   Lepor, Herbert ^b   Partin, Alan W ^c   Chan, Dan W ^c   Sokoll, Lori J ^c   Cheli, Carol D ^d   Thiel, Robert P ^e   Fournier, David R ^a   Duffy, David C ^f  

^a QUANTERIX CORPORATION   (United States)

^b NEW YORK UNIVERSITY   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d Clinical Consulting   (United States)

^e THIEL Statistical Consultants   (United States)

^f Twin Lights Bioscience Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

ACCURACY; ADULT; AGED; ARTICLE; CONTROLLED STUDY; DIGITAL IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; IMMUNOASSAY; LIMIT OF QUANTITATION; MALE; PILOT STUDY; PROSTATE CANCER; RADICAL RETROPUBIC PROSTATECTOMY; RECURRENCE RISK; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

AUTOMATIC DATA PROCESSING; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; MALE; MICROCHEMISTRY; MIDDLE AGED; PILOT PROJECTS; PROSTATE-SPECIFIC ANTIGEN; PROSTATECTOMY; PROSTATIC NEOPLASMS; PROTEIN ARRAY ANALYSIS; REPRODUCIBILITY OF RESULTS; RETROSPECTIVE STUDIES; SENSITIVITY AND SPECIFICITY;

EID: 82755162442     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2011.169540     Document Type: Article

References (35)

1. Oesterling JE. Prostate specific antigen: a critical assessment of the most useful tumor marker for adenocarcinoma of the prostate. J Urol 1991;145:907.
2. Diamandis EP. Prostate specific antigen - its usefulness in clinical medicine. Trends Endocrinol Metab 1998;9:310-6. (Pubitemid 28471340)
3. Sia M, Pickles T, Morton G, Souhami L, Lukka H, Warde P. Salvage radiotherapy following biochemical relapse after radical prostatectomy: proceedings of the Genito-Urinary Radiation Oncologists of Canada consensus meeting. Consensus Statement. Can Urol Assoc J 2008;2:500-7.
4. Gunnar A. Second-line therapy after radical prostatectomy failure: for whom? When? How? Eur Urol 2007;51:1155-8.
5. Bock JL, Klee GG. How sensitive is a prostate specific antigen measurement? How sensitive does it need to be? Arch Pathol Lab Med 2004;128:341-3. (Pubitemid 38316085)
6. Freedland SJ, Moul JW. Prostate specific antigen recurrence after definitive therapy. J Urol 2007;177:1985-91. (Pubitemid 46726405)
7. Han M, Partin AW, Pound CR, Epstein JI, Walsh PC. Long-term biochemical disease-free and cancer-specific survival following anatomic radical retropubic prostatectomy: the 15-year Johns Hopkins experience. Urol Clin North Am 2001;28:555-65. (Pubitemid 32916759)
8. Catalona WJ, Smith DS. 5-Year tumor recurrence rates after anatomical radical retropubic prostatectomy for prostate cancer. J Urol 1994;152:1837-42. (Pubitemid 24322641)
9. Bianco FJ Jr, Scardino PT, Eastham JA. Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function. Urology 2005;66:83-94. (Pubitemid 41356564)
10. Pound CR, Partin AW, Eisenberger MA, Chan DW, Pearson JD, Walsh PC. Natural history of progression after PSA elevation following radical prostatectomy. JAMA 1999;281:1591-7. (Pubitemid 29211767)
11. Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, et al. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol 2009;181:956-62.
12. Trock BJ, Han M, Freedland SJ, Humphreys EB, DeWeese TL, Partin AW, et al. Prostate cancer-specific survival following salvage radiotherapy vs observation in men with biochemical recurrence after radical prostatectomy. JAMA 2008;299:2760-9. (Pubitemid 351846851)
13. Stephenson AJ, Shariat SF, Zelefsky MJ, Kattan MW, Butler BE, Teh BS, et al. Salvage radiotherapy for recurrent prostate cancer after radical prostatectomy. JAMA 2004;291:1325-32. (Pubitemid 38541647)
14. Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, et al. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol 2007;25:2035-41. (Pubitemid 46972788)
15. Yu H, Diamandis, EP. Ultrasensitive time-resolved immunofluorometric assay of prostate-specific antigen in serum and preliminary clinical studies. Clin. Chem 1993;39:2108.
16. Yu H, Diamandis EP, Wong PY, Nam R, Trachtenberg J. Detection of prostate cancer relapse with prostate specific antigen monitoring at levels of 0.001 to 0.1 μg/L. J Urol 1997;157:913-8. (Pubitemid 27066278)
17. Vassilikos EJ, Yu H, Trachtenberg J, Nam RK, Narod SA, Bromberg IL, et al. Relapse and cure rates of prostate cancer patients after radical prostatectomy and 5 years of follow-up. Clin Biochem 2000;33:115-23. (Pubitemid 30212819)
18. Haese A, Huland E, Graefen M, Hammerer P, Noldus J, Huland H. Ultrasensitive detection of prostate specific antigen in the followup of 422 patients after radical prostatectomy. J Urol 1999;161:1206-11. (Pubitemid 29426118)
19. Hong SK, Park HZ, Lee WK, Kim DS, Lee JS, Doo SH, et al. Prognostic significance of undetectable ultrasensitive prostate-specific antigen nadir after radical prostatectomy. Urology 2010;76:723-7.
20. Doherty AP, Bower M, Smith GL, Miano R, Mannlon EM, Mitchell H, et al. Undetectable ultrasensitive PSA after radical prostatectomy for prostate cancer predicts relapse-free survival. Br J Cancer 2000;83:1432-6.
21. Shen S, Lepor H, Yaffee R, Taneja SS. Ultrasensitive serum prostate specific antigen nadir accurately predicts the risk of early relapse after radical prostatectomy. J Urol 2005;173:777-80. (Pubitemid 40239340)
22. Sakai I, Harada K, Kurahashi T, Muramaki M, Yamanaka K, Hara I, et al. Usefulness of the nadir value of serum prostate specific antigen measured by an ultrasensitive assay as a predictor of biochemical recurrence after radical prostatectomy for clinically localized prostate cancer. Urol Int 2006;76:227-31.
23. Eisenberg ML, Davies BJ, Cooperberg MR, Cowan JE, Carroll PR. Prognostic implications of an undetectable ultrasensitive prostate-specific antigen level after radical prostatectomy. Eur Urol 2010;57:622-9.
24. Moreira DM, Presti JC Jr, Aronson WJ, Terris MK, Kane CJ, Amling CL, et al. Postoperative prostate-specific antigen nadir improves accuracy for predicting biochemical recurrence after radical prostatectomy: results from the Shared Equal Access Regional Cancer Hospital (SEARCH) and Duke Prostate Center databases. Int J Urol 2010 Nov;17:914-22.
25. McDermed JE, Adams TH, Klem RE, Diamandis EP. Ultrasensitive PSA measurements using NADiA technology in men following radical prostatectomy (RP) [Abstract]. In: 2009 Genitourinary Cancers Symposium; 2009 Feb 26-28; Orlando, FL. Abstract nr 121.
26. Thaxton CS, Elghanianc R, Thomasa AD, Stoevac SI, Leec JS, Smith ND, et al. Nanoparticle-based bio-barcode assay redefines "undetectable" PSA and biochemical recurrence after radical prostatectomy. Proc Nat Acad Sci U S A 2009;106:18437-42.
27. Rissin DM, Kan CW, Campbell TG, Howes SC, Fournier DR, Song L, et al. Single-molecule enzyme-linked immunosorbent assay detects serum proteins at subfemtomolar concentrations. Nat Biotech 2010;28:595-9.
28. Rissin DM, Fournier DR, Piech T, Kan CW, Campbell TG, Song L, et al. Simultaneous detection of single molecules and singulated ensembles of molecules enables immunoassays with broad dynamic range. Anal Chem 2011;83:2279-85.
29. Rissin D, Walt D. Digital concentration readout of single enzyme molecules using femtoliter arrays and Poisson statistics. Nano Lett 2006;6:520-3.
30. CLSI. Evaluation of the linearity of quantitative measurement procedure: a statistical approach; approved guideline. 2nd ed. CLSI Document EP6-A. Wayne (PA): CLSI; 2003.
31. CLSI. Evaluation of precision performance of quantitative measurement methods; approved guideline. 2nd ed. CLSI Document EP5-A2. Wayne (PA): CLSI; 2004.
32. ADVIA Centaur PSA assay specifications. http://www.medical.siemens.com/ siemens/en-GLOBAL/gg-diag-FBAs/files/Assays/hisstory/PSA-Assay.pdf (Accessed February 2011).
33. Lepor H, Cheli CD, Thiel RP, Taneja SS, Laze J, Chan DW, et al. Clinical evaluation of a novel method for measurement of prostate-specific antigen, AccuPSA™, as a predictor of 5-year biochemical recurrence-free survival after radical prostatectomy: results of a pilot study. BJU Int [Epub ahead of print 2011 Oct 12].
34. Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, et al. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA 2006;296:2329-35. (Pubitemid 44749360)
35. Van der Kwast TH, Bolla M, Van Poppel H, Van Cangh P, Vekemans K, Da Pozzo L, et al. Identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. J Clin Oncol 2007;25:4178-86. (Pubitemid 47548556)