Biomarkers Definitions Working Group: Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Therap. 2001, 69: 89-95.
Article
Google Scholar
Chan DW, Schwartz MK: Tumor markers: Introduction and general principles. Tumor markers. Physiology, pathobiology, technology, and clinical applications. Edited by: Diamandis EP, Fritsche HA, Lilja H, Chan DW, Schwartz MK. 2002, 9-17. AACCPress: Washington,
Google Scholar
Chan DW: Will cancer proteomics suffer from premature death?. Clin Prot. 2010, 6: 1-3. 10.1007/s12014-010-9044-1. 10.1007/s12014-010-9044-1
Article
CAS
Google Scholar
Diamandis EP: Cancer biomarkers: Can we turn recent failures into success?. J Natl Canc Inst. 2010, 102: 1-6.
Article
Google Scholar
Ioannidis JPA: Biomarker failures. Clin Chem. 2013, 59: 202-204. 10.1373/clinchem.2012.185801
Article
CAS
PubMed
Google Scholar
Pavlou MP, Diamandis EP, Blaustig IM: The long journey of cancer biomarkers from the bench to the clinic. Clin Chem. 2013, 59: 147-157. 10.1373/clinchem.2012.184614
Article
CAS
PubMed
Google Scholar
Regnier FE, Skates SJ, Mesri M, Rodriguez H, Težak Ž, Kondratovich MV, Alterman MA, Levin JD, Roscoe D, Reilly E, Callaghan J, Kelm K, Brown D, Philip R, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Ransohoff DF, Mansfield E, Anderson NL: Protein-based multiplex assays: Mock presubmission to the US Food and Drug Administration. Clin Chem. 2010, 56: 165-171. 10.1373/clinchem.2009.140087
Article
CAS
PubMed
Google Scholar
Zhang Z, Chan DW: Cancer proteomics: In pursuit of “true” biomarker discovery. Cancer Epidemiol Biomark. 2005, 14: 2283-2286. 10.1158/1055-9965.EPI-05-0774. 10.1158/1055-9965.EPI-05-0774
Article
CAS
Google Scholar
Zhang Z, Chan DW: The road from discovery to clinical diagnostics: Lessons learned from the first FDA-cleared in vitro diagnostic multivariate index assay of proteomic biomarkers. Cancer Epidemiol Biomark Prev. 2010, 19: 2995-2999. 10.1158/1055-9965.EPI-10-0580. 10.1158/1055-9965.EPI-10-0580
Article
CAS
Google Scholar
Vidal M, Chan DW, Gerstein M, Mann M, Omenn GS, Tagle D, Sechi S: The human proteome – a scientific opportunity for transforming diagnostics, therapeutics, and healthcare. Clin Proteomics. 2012, 9: 6- 10.1186/1559-0275-9-6
Article
PubMed Central
PubMed
Google Scholar
Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, Winget M, Yasui Y: Phases of biomarker development for early detection of cancer. J Natl Cancer Inst. 2001, 93: 1054-1061. 10.1093/jnci/93.14.1054
Article
CAS
PubMed
Google Scholar
Schiess R, Wollscheid B, Aebersold R: Targeted proteomic strategy for clinical biomarker discovery. Mol Onc. 2009, 3: 33-44. 10.1016/j.molonc.2008.12.001. 10.1016/j.molonc.2008.12.001
Article
CAS
Google Scholar
McShane LM, Hayes DF: Publication of tumor marker research results: The necessity for complete and transparent reporting. J Clin Onc. 2012, 30: 4223-4232. 10.1200/JCO.2012.42.6858. 10.1200/JCO.2012.42.6858
Article
Google Scholar
Rifai N, Gillette MA, Carr SA: Protein biomarker discovery and validation: the long and uncertain path to clinical utility. Nature Biotech. 2006, 24: 971-983. 10.1038/nbt1235. 10.1038/nbt1235
Article
CAS
Google Scholar
Silberring J, Ciborowski P: Biomarker discovery and clinical proteomics. Trends Anal Chem. 2010, 29: 128-140. 10.1016/j.trac.2009.11.007. 10.1016/j.trac.2009.11.007
Article
CAS
Google Scholar
Sturgeon C, Hill R, Hortin GL, Thompson D: Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory. Proteomics Clin Appl. 2010, 4: 892-903. 10.1002/prca.201000073
Article
PubMed Central
CAS
PubMed
Google Scholar
Fung ET: A recipe for proteomics diagnostic test development: The OVA1 test, from biomarker discovery to FDA clearance. Clin Chem. 2010, 56: 327-329. 10.1373/clinchem.2009.140855
Article
CAS
PubMed
Google Scholar
Agilent Technologies: Validation of analytical methods. 2010,http://www.chem.agilent.com/Library/primers/Public/5990-5140EN.pdf,
Google Scholar
Bansal S, DeStefano A: Key elements of bioanalytical method validation for small molecules. AAPS Journal. 2007, 9: E109-E114. 10.1208/aapsj0901011
Article
PubMed Central
CAS
PubMed
Google Scholar
Clinical and Laboratory Standards Institute: EP06-A: Evaluation of the linearity of quantitative measurement procedures: A statistical approach; Approved guideline. 2003, PA: Wayne,
Google Scholar
Clinical and Laboratory Standards Institute: EP05-A2: Evaluation of precision performance of quantitative measurement methods; Approved guideline. 2004, PA: Wayne, 2,
Google Scholar
Clinical and Laboratory Standards Institute: EP07-A2: Interference testing in clinical chemistry; Approved guideline. 2005, PA: Wayne, 2,
Google Scholar
Clinical and Laboratory Standards Institute: EP14-A2: Evaluation of matrix effects; Approved guideline. 2005, PA: Wayne, 2,
Google Scholar
Clinical and Laboratory Standards Institute: EP10-A3: Preliminary evaluation of quantitative clinical laboratory measurement procedures; Approved guideline. 2006, PA: Wayne, 3,
Google Scholar
ICH Expert Working Group: Validation of analytical procedures: Text and Methodology Q2(R1). 2005,http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf,
Google Scholar
National Association of Testing Authorities, Australia: Guidelines for the validation and verification of quantitative and qualitative test methods. 2012,http://www.nata.asn.au/phocadownload/publications/Guidance_information/tech-notes-information-papers/technical_note_17.pdf,
Google Scholar
U.S. Department of Health and Human Services: Guidance for industry – Bioanalytical method validation. 2001,http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf,
Google Scholar
Westgard JO: Basic method validation. 2008, Madison: Westgard QC, Inc., 3,
Google Scholar
Linnet K, Boyd JC: Selection and analytical evaluation of methods – With statistical techniques. Tietz fundamentals of clinical chemistry. Edited by: Burtis CA, Ashwood ER, Bruns DE. 2008, 201-228. St. Louis: Saunders Elsevier, 6,
Google Scholar
Endres DB: Method evaluation. Contemporary practice in clinical chemistry. Edited by: Clarke W. 2011, 43-53. Washington: AACCPress, 2,
Google Scholar
Fraser CG: Biological variation: From principles to practice. 2001, Washington: AACCPress,
Google Scholar
Ricós C, Iglesias N, García-Lario JV, Simón M, Cava F, Hernández A, Perich C, Minchinela J, Alvarez V, Doménech MV, Jiménez CV, Biosca C, Tena R: Within-subject biological variation in disease: collated data and clinical consequences. Ann Clin Biochem. 2007, 44: 343-352. 10.1258/000456307780945633
Article
PubMed
Google Scholar
Sturgeon CM, Hoffman BR, Chan DW, Ch’ng SL, Hammond E, Hayes DF, Liotta LA, Petricoin EF, Schmitt M, Semmes OJ, Söletormos G, van der Merwe E, Diamandis EP: National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in clinical practice: Quality requirements. Clin Chem. 2008, 54: e1-e10. 10.1373/clinchem.2007.094144
Article
CAS
PubMed
Google Scholar
Clinical and Laboratory Standards Institute: P15-A2: User verification of performance for precision and trueness; Approved guideline. 2005, PA: Wayne, Second edition,
Google Scholar
Stenman UH, Tiitinen A, Alfthan H, Valmu L: The classification, functions and clinical use of different isoforms of HCG. Hum Repr Update. 2006, 12: 769-784. 10.1093/humupd/dml029. 10.1093/humupd/dml029
Article
CAS
Google Scholar
Alfthan H, Haglund C, Roberts P, Stenman UH: Elevation of free β subunit of human choriogonadotropin and core β fragment of human choriogonadotropin in the serum and urine of patients with malignant pancreatic and biliary disease. Canc Res. 1992, 52: 4628-4633.
CAS
Google Scholar
Cole LA: Immunoassay of human chorionic gonadotropin, its free subunits, and metabolites. Clin Chem. 1997, 43: 2233-2243.
CAS
PubMed
Google Scholar
Cole LA, Khanlian SA, Sutton JM, Davies S, Stephens ND: Hyperglycosylated hCG (Invasive Trophoblast Antigen, ITA) a key antigen for early pregnancy detection. Clin Biochem. 2003, 36: 647-655. 10.1016/S0009-9120(03)00108-5
Article
CAS
PubMed
Google Scholar
Saller B, Clara R, Spöttl G, Siddle K, Mann K: Testicular cancer secretes intact human choriogonadotropin (hCG) and its free β-subunit: Evidence that hCG (+ hCG-β) assays are the most reliable in diagnosis and follow-up. Clin Chem. 1990, 36: 234-239.
CAS
PubMed
Google Scholar
Sturgeon CM, Berger P, Bidart JM, Birken S, Burns C, Norman RJ, Stenman UH: Differences in recognition of the 1st WHO international reference reagents for hCG-related isoforms by diagnostic immunoassays for human chorionic gonadotropin. Clin Chem. 2009, 55: 1484-1491. 10.1373/clinchem.2009.124578
Article
CAS
PubMed
Google Scholar
Milford Ward A, Catto JWF, Hamdy FC: Prostate-specific antigen: biology, biochemistry and available commercial assays. Ann Clin Biochem. 2001, 38: 633-651. 10.1258/0004563011901055
Article
Google Scholar
Chan DW, Sokoll LJ: Prostate-specific antigen: Advances and challenges. Clin Chem. 1999, 45: 755-756.
CAS
PubMed
Google Scholar
Meany DL, Sokoll LJ, Chan DW: Early detection of cancer: Immunoassays for plasma tumor markers. Expert Opin Med Diagn. 2009, 3: 597-605. 10.1517/17530050903266830
Article
PubMed Central
CAS
PubMed
Google Scholar
Chan DW, Sokoll LJ: WHO first international standards for prostate-specific antigen: The beginning of the end for assay discrepancies?. Clin Chem. 2000, 46: 1291-1292.
CAS
PubMed
Google Scholar
Birken S, Berger P, Bidart JM, Weber M, Bristow A, Norman R, Sturgeon C, Stenman UH: Preparation and characterization of new WHO reference reagents for human chorionic gonadotropin and metabolites. Clin Chem. 2003, 49: 144-154. 10.1373/49.1.144
Article
CAS
PubMed
Google Scholar
Armbruster DA, Pry T: Limit of blank, limit of detection and limit of quantitation. Clin Biochem Rev. 2008, 29 (Suppl 1): 49-52.
Google Scholar
Linnet K, Kondratovich M: Partly nonparametric approach for determining the limit of detection. Clin Chem. 2004, 50: 732-740. 10.1373/clinchem.2003.029983
Article
CAS
PubMed
Google Scholar
, : EP17-A2: Protocols for determination of limits of detection and limits of quantitation; Approved guideline. 2012, PA: Wayne, Second edition,
Google Scholar
Kroll MH, Elin RJ: Interference with clinical laboratory analyses. Clin Chem. 1994, 40: 1996-2005.
CAS
PubMed
Google Scholar
Chan DW: Immunoassay: A practical guide. 1987, New York, NY: Academic Press,
Google Scholar
Devine PL: High dose hook effect and sample carryover in carcinoembryonic antigen assay performed on the Boehringer-Mannheim ES-300 automated immunoassay system. Eur J Clin Chem Clin Biochem. 1996, 34: 573-574.
CAS
PubMed
Google Scholar
Jassam N, Jones CM, Briscoe T, Horner JH: The hook effect: a need for constant vigilance. Ann Clin Biochem. 2006, 43: 314-317. 10.1258/000456306777695726
Article
CAS
PubMed
Google Scholar
Leboeuf R, Langlois MF, Martin M, Ahnadi CE, Fink GD: Hook effect in calcitonin immunoradiometric assay in patients with metastatic medullary thyroid carcinoma: Case report and review of literature. J Clin Endocrin Metab. 2005, 91: 361-364. 10.1210/jc.2005-1429. 10.1210/jc.2005-1429
Article
Google Scholar
O’Reilly SM, Rustin GJS: Mismanagement of choriocarcinoma due to a false low HCG measurement. Int J Gynecol Cancer. 1993, 3: 186-188. 10.1046/j.1525-1438.1993.03030186.x
Article
PubMed
Google Scholar
Emerson JF, Lai KKY: Endogenous antibody interferences in immunoassays. Lab Med. 2013, 44: 69-73.
Article
Google Scholar
Clinical and Laboratory Standards Institute: I/LA30-A: Immunoassay interference by endogenous antibodies; Approved guideline. 2008, PA: Wayne,
Google Scholar
Sturgeon CM, Viljoen A: Analytical error and interference in immunoassay: minimizing risk. Ann Clin Biochem. 2011, 48: 418-432. 10.1258/acb.2011.011073
Article
CAS
PubMed
Google Scholar
Tate J, Ward G: Interferences in immunoassay. Clin Biochem Rev. 2004, 25: 105-120.
PubMed Central
PubMed
Google Scholar
Haeckel R: Proposals for the description and measurement of carry-over effects in clinical chemistry. Pure Appl Chem. 1991, 63: 301-306. 10.1351/pac199163020301. 10.1351/pac199163020301
Article
Google Scholar
Armbruster DA, Alexander DB: Sample to sample carryover: A source of analytical laboratory error and its relevance to integrated clinical chemistry/immunoassay systems. Clin Chim Acta. 2006, 373: 37-43. 10.1016/j.cca.2006.04.022
Article
CAS
PubMed
Google Scholar
Sturgeon CM: Limitations of assay techniques for tumor markers. Tumor markers. Physiology, pathobiology, technology, and clinical applications. Edited by: Diamandis EP, Fritsche HA, Lilja H, Chan DW, Schwartz MK. 2002, 65-81. Washington: AACCPress,
Google Scholar
Laboratory instrumentation product guide: Automated immunoassay analyzers. CAP TODAY. 2010,http://www.cap.org/apps/docs/cap_today/0610/0610_CAPTODAY_AutomatedImmunoassayAnalyzersGuide.pdf, , July Issue,
Linnet K, Bossuyt PMM, Moons KGM, Reitsma JH: Quantifying the accuracy of a diagnostic test or marker. Clin Chem. 2012, 58: 1292-1301. 10.1373/clinchem.2012.182543
Article
CAS
PubMed
Google Scholar
Moons KG, de Groot JA, Linnet K, Reitsma JB, Bossuyt PM: Quantifying the added value of a diagnostic test or marker. Clin. Chem. 2012, 58: 1408-1417. 10.1373/clinchem.2012.182550
Article
PubMed
Google Scholar
Lalkhen AG, McCluskey A: Clinical tests: sensitivity and specificity. Cont Ed Anaesth Crit Care & Pain. 2008, 8: 221-223. 10.1093/bjaceaccp/mkn041. 10.1093/bjaceaccp/mkn041
Article
Google Scholar
Lijmer JG, Leeflang M, Bossuyt PMM: Proposals for a phased evaluation of medical tests. Med Dec Making. 2009, 29: E13-E21. 10.1177/0272989X09336144. 10.1177/0272989X09336144
Article
Google Scholar
Zhou XH, Obuchowski NA, McClish DK: Statistical methods in diagnostic medicine. 2002, New York: John Wiley & Sons,
Book
Google Scholar
Bachmann LM, Puhan MA, Ter Riet G, Bossuyt PM: Sample sizes of studies on diagnostic accuracy: literature survey. Brit Med J. 2006, 332: 1127-1129. 10.1136/bmj.38793.637789.2F
Article
PubMed Central
PubMed
Google Scholar
Bossuyt PMM, Reitsma JB, Linnet K, Moons KGM: Beyond diagnostic accuracy: The clinical utility of diagnostic tests. Clin Chem. 2012, 58: 1636-1643. 10.1373/clinchem.2012.182576
Article
CAS
PubMed
Google Scholar
Van den Bruel A, Aertgeerts B, Buntinx F: Results of diagnostic accuracy studies are not always validated. J Clin Epidemiol. 2006, 59: 559-566.
Article
PubMed
Google Scholar
Weinstein S, Obuchowski NA, Lieber ML: Clinical evaluation of diagnostic tests. Am J Radiol. 2005, 184: 14-19.
Google Scholar
Zweig MH, Campbell G: Receiver-operating characteristic (ROC) plots: A fundamental evaluation tool in clinical medicine. Clin Chem. 1993, 39: 561-577.
CAS
PubMed
Google Scholar
Fluss R, Faraggi D, Reiser B: Estimation of the Youden index and its associated cutoff point. Biometrical J. 2005, 47: 458-472. 10.1002/bimj.200410135. 10.1002/bimj.200410135
Article
Google Scholar
Perkins NJ, Schisterman EF: The inconsistency of “optimal” cutpoints obtained using two critera based on the receiver operating characteristic curve. Am J Epidemiol. 2006, 163: 670-675. 10.1093/aje/kwj063
Article
PubMed Central
PubMed
Google Scholar
Park SH, Goo JM, Jo CH: Receiver Opearting Characteristic (ROC) Curve: Practical Review for Radiologists. Korean J Radiol. 2004, 5: 11-18. 10.3348/kjr.2004.5.1.11
Article
PubMed Central
PubMed
Google Scholar
Obuchowski NA: ROC analysis. Am J Radiol. 2005, 184: 364-372.
Google Scholar
Obuchowski NA, Lieber ML, Wians FH: ROC curves in Clinical Chemistry: Uses, misuses, and possible solutions. Clin Chem. 2004, 50: 1118-1125. 10.1373/clinchem.2004.031823
Article
CAS
PubMed
Google Scholar
Scott MG: When do new biomarkers make economic sense?. Scand J Clin Lab Investigation. 2010, 70: 90-95. 10.3109/00365513.2010.493411. 10.3109/00365513.2010.493411
Article
Google Scholar
Van den Bruel A, Cleemput I, Aertgeerts B, Ramaekers D, Buntinx F: The evaluation of diagnostic tests: Evidence on technical and diagnostic accuracy, impact on patient outcome and cost-effectiveness is needed. J Clin Epidemiol. 2007, 60: 1116-1122. 10.1016/j.jclinepi.2007.03.015
Article
CAS
PubMed
Google Scholar
Neumann PJ, Tunis SR: Medicare and medical technology – The growing demand for relevant outcomes. New Engl J Med. 2010, 362: 377-379. 10.1056/NEJMp0912062
Article
CAS
PubMed
Google Scholar
Howanitz JH, Howanitz PJ: Laboratory results – Timeliness as a quality attribute and strategy. Am J Clin Pathol. 2001, 116: 311-315. 10.1309/H0DY-6VTW-NB36-U3L6
Article
CAS
PubMed
Google Scholar
Jones BA, Walsh MK, Ruby SG: Hospital nursing satisfaction with clinical laboratory services. A College of American Pathologists Q-Probes study of 162 institutions. Arch Pathol Lab Med. 2006, 130: 1756-1761.
PubMed
Google Scholar
Valenstein P, Walsh M: Five-year follow-up of routine outpatient test turnaround time. A College of American Pathologists Q-Probes study. Arch Pathol Lab Med. 2003, 127: 1421-1423.
PubMed
Google Scholar
Novis DA, Walsh MK, Dale JC, Howanitz PJ: Continuous monitoring of stat and routine outlier turnaround times. Two College of American Pathologists Q-Tracks monitors in 291 hospitals. Arch Pathol Lab Med. 2004, 128: 621-626.
PubMed
Google Scholar
Adonna TA, Abbatiello SE, Schilling B, Skates SJ, Mani DR, Bunk DM, Spiegelman CH, Zimmerman LJ, Ham AJL, Keshishian H, Hall SC, Allen S, Blackman RK, Borchers CH, Buck C, Cardasis HL, Cusack MP, Dodder NG, Bigxon BW, Held JM, Hiltke T, Jackson A, Johansen EB, Kinsinger CR, Li J, Mesri M, Neubert TA, Niles RK, Pulsipher TC: Multi-site assessment of the precision and reproducibility of multiple reaction monitoring-based measurements of proteins in plasma. Nat Biotech. 2009, 27: 633-641. 10.1038/nbt.1546. 10.1038/nbt.1546
Article
Google Scholar
Decision Summary, 510(k) application number k100321.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=33256,
Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff, Issued July 13. 2012,http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm310375.htm,