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Reference Intervals: Comparison of Calculation Methods and Evaluation of Procedures for Merging Reference Measurements From Two US Medical Centers.

Klee GG, Ichihara K, Ozarda Y, Baumann NA, Straseski J, Bryant SC, Wood-Wentz CM.

Am J Clin Pathol. 2018 Oct 24;150(6):545-554. doi: 10.1093/ajcp/aqy082.


Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference.

Ceriotti F, Fernandez-Calle P, Klee GG, Nordin G, Sandberg S, Streichert T, Vives-Corrons JL, Panteghini M.

Clin Chem Lab Med. 2017 Feb 1;55(2):189-194. doi: 10.1515/cclm-2016-0091.


Interleukins 6 and 8 and abdominal fat depots are distinct correlates of lipid moieties in healthy pre- and postmenopausal women.

Veldhuis JD, Dyer RB, Trushin SA, Bondar OP, Singh RJ, Klee GG.

Endocrine. 2016 Dec;54(3):671-680. doi: 10.1007/s12020-016-1041-3. Epub 2016 Jul 22.


Multiple calibrator measurements improve accuracy and stability estimates of automated assays.

Akbas N, Budd JR, Klee GG.

Scand J Clin Lab Invest. 2016;76(2):177-80. doi: 10.3109/00365513.2015.1126760. Epub 2016 Jan 19.


Androgen Receptor Upregulation Mediates Radioresistance after Ionizing Radiation.

Spratt DE, Evans MJ, Davis BJ, Doran MG, Lee MX, Shah N, Wongvipat J, Carnazza KE, Klee GG, Polkinghorn W, Tindall DJ, Lewis JS, Sawyers CL.

Cancer Res. 2015 Nov 15;75(22):4688-96. doi: 10.1158/0008-5472.CAN-15-0892. Epub 2015 Oct 2.


The prostate health index selectively identifies clinically significant prostate cancer.

Loeb S, Sanda MG, Broyles DL, Shin SS, Bangma CH, Wei JT, Partin AW, Klee GG, Slawin KM, Marks LS, van Schaik RH, Chan DW, Sokoll LJ, Cruz AB, Mizrahi IA, Catalona WJ.

J Urol. 2015 Apr;193(4):1163-9. doi: 10.1016/j.juro.2014.10.121. Epub 2014 Nov 15.


Serum concentrations of prostate-specific antigen measured using immune extraction, trypsin digestion, and tandem mass spectrometry quantification of LSEPAELTDAVK peptide.

Klee EW, Bondar OP, Goodmanson MK, Trushin SA, Bergstralh EJ, Singh RJ, Anderson NL, Klee GG.

Arch Pathol Lab Med. 2014 Oct;138(10):1381-6. doi: 10.5858/arpa.2013-0462-OA.


Verifying performance characteristics of quantitative analytical systems: calibration verification, linearity, and analytical measurement range.

Killeen AA, Long T, Souers R, Styer P, Ventura CB, Klee GG.

Arch Pathol Lab Med. 2014 Sep;138(9):1173-81. doi: 10.5858/arpa.2013-0051-CP.


The cistrome and gene signature of androgen receptor splice variants in castration resistant prostate cancer cells.

Lu J, Lonergan PE, Nacusi LP, Wang L, Schmidt LJ, Sun Z, Van der Steen T, Boorjian SA, Kosari F, Vasmatzis G, Klee GG, Balk SP, Huang H, Wang C, Tindall DJ.

J Urol. 2015 Feb;193(2):690-8. doi: 10.1016/j.juro.2014.08.043. Epub 2014 Aug 14.


Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals.

Akbas N, Schryver PG, Algeciras-Schimnich A, Baumann NA, Block DR, Budd JR, Gaston SJ, Klee GG.

Clin Biochem. 2014 Nov;47(16-17):158-63. doi: 10.1016/j.clinbiochem.2014.08.005. Epub 2014 Aug 15.


Reprint of "Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits".

Hyltoft Petersen P, Klee GG.

Clin Chim Acta. 2014 May 15;432:127-34. doi: 10.1016/j.cca.2014.04.002. Epub 2014 Apr 18. Review.


Immunologic and mass-spectrometric estimates of SHBG concentrations in healthy women.

Veldhuis JD, Dyer RB, Trushin SA, Bondar OP, Singh RJ, Klee GG.

Metabolism. 2014 Jun;63(6):783-92. doi: 10.1016/j.metabol.2014.03.010. Epub 2014 Mar 21.


Mass spectrometry measurements of prostate-specific antigen (PSA) peptides derived from immune-extracted PSA provide a potential strategy for harmonizing immunoassay differences.

Klee EW, Bondar OP, Goodmanson MK, Trushin SA, Singh RJ, Anderson NL, Klee GG.

Am J Clin Pathol. 2014 Apr;141(4):527-33. doi: 10.1309/AJCP8PEL0YXAHDVK.


Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits.

Hyltoft Petersen P, Klee GG.

Clin Chim Acta. 2014 Mar 20;430:1-8. doi: 10.1016/j.cca.2013.12.014. Epub 2013 Dec 18.


Immunological and mass spectrometric assays of SHBG: consistent and inconsistent metabolic associations in healthy men.

Veldhuis JD, Bondar OP, Dyer RB, Trushin SA, Klee EW, Singh RJ, Klee GG.

J Clin Endocrinol Metab. 2014 Jan;99(1):184-93. doi: 10.1210/jc.2013-2642. Epub 2013 Dec 20.


Racial differences in longitudinal changes in serum prostate-specific antigen levels: the Olmsted County Study and the Flint Men's Health Study.

Sarma AV, St Sauver JL, Jacobson DJ, McGree ME, Klee GG, Lieber MM, Girman CJ, Hollingsworth JM, Jacobsen SJ; Urologic Diseases in America Project.

Urology. 2014 Jan;83(1):88-93. doi: 10.1016/j.urology.2013.08.025. Epub 2013 Oct 16.


Empiric validation of simulation models for estimating glucose meter performance criteria for moderate levels of glycemic control.

Karon BS, Boyd JC, Klee GG.

Diabetes Technol Ther. 2013 Dec;15(12):996-1003. doi: 10.1089/dia.2013.0086. Epub 2013 Sep 13.


Category-specific uncertainty modeling in clinical laboratory measurement processes.

Ramamohan V, Yih Y, Abbott JT, Klee GG.

Clin Chem Lab Med. 2013 Dec;51(12):2273-80. doi: 10.1515/cclm-2013-0357.


Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population.

Karnes RJ, Bergstralh EJ, Davicioni E, Ghadessi M, Buerki C, Mitra AP, Crisan A, Erho N, Vergara IA, Lam LL, Carlson R, Thompson DJ, Haddad Z, Zimmermann B, Sierocinski T, Triche TJ, Kollmeyer T, Ballman KV, Black PC, Klee GG, Jenkins RB.

J Urol. 2013 Dec;190(6):2047-53. doi: 10.1016/j.juro.2013.06.017. Epub 2013 Jun 11.


Associations of candidate biomarkers of vascular disease with the ankle-brachial index and peripheral arterial disease.

Ye Z, Ali Z, Klee GG, Mosley TH Jr, Kullo IJ.

Am J Hypertens. 2013 Apr;26(4):495-502. doi: 10.1093/ajh/hps073. Epub 2013 Jan 11.


Analytical performance specifications: relating laboratory performance to quality required for intended clinical use.

Dalenberg DA, Schryver PG, Klee GG.

Clin Lab Med. 2013 Mar;33(1):55-73. doi: 10.1016/j.cll.2012.11.005. Epub 2012 Dec 20. Review.


Prospective multicenter evaluation of the Beckman Coulter Prostate Health Index using WHO calibration.

Loeb S, Sokoll LJ, Broyles DL, Bangma CH, van Schaik RH, Klee GG, Wei JT, Sanda MG, Partin AW, Slawin KM, Marks LS, Mizrahi IA, Shin SS, Cruz AB, Chan DW, Roberts WL, Catalona WJ.

J Urol. 2013 May;189(5):1702-6. doi: 10.1016/j.juro.2012.11.149. Epub 2012 Nov 30.


Application of mathematical models of system uncertainty to evaluate the utility of assay calibration protocols.

Ramamohan V, Abbott J, Klee GG, Yih Y.

Clin Chem Lab Med. 2012 Nov;50(11):1945-51. doi: 10.1515/cclm-2012-0265.


Adrenomedullin is up-regulated in patients with pancreatic cancer and causes insulin resistance in β cells and mice.

Aggarwal G, Ramachandran V, Javeed N, Arumugam T, Dutta S, Klee GG, Klee EW, Smyrk TC, Bamlet W, Han JJ, Rumie Vittar NB, de Andrade M, Mukhopadhyay D, Petersen GM, Fernandez-Zapico ME, Logsdon CD, Chari ST.

Gastroenterology. 2012 Dec;143(6):1510-1517.e1. doi: 10.1053/j.gastro.2012.08.044. Epub 2012 Sep 6.


Global methylation profiling for risk prediction of prostate cancer.

Mahapatra S, Klee EW, Young CY, Sun Z, Jimenez RE, Klee GG, Tindall DJ, Donkena KV.

Clin Cancer Res. 2012 May 15;18(10):2882-95. doi: 10.1158/1078-0432.CCR-11-2090.


Multi-center analytical performance evaluation of the Access Hybritech® p2PSA immunoassay.

Sokoll LJ, Chan DW, Klee GG, Roberts WL, van Schaik RH, Arockiasamy DA, Broyles DL, Carlson CM, Mizrahi IA, Pierson TB, Tam JE.

Clin Chim Acta. 2012 Aug 16;413(15-16):1279-83. doi: 10.1016/j.cca.2012.04.015. Epub 2012 Apr 20.


Longitudinal changes of benign prostate-specific antigen and [-2]proprostate-specific antigen in seven years in a community-based sample of men.

Rhodes T, Jacobson DJ, McGree ME, St Sauver JL, Girman CJ, Lieber MM, Klee GG, Demissie K, Jacobsen SJ.

Urology. 2012 Mar;79(3):655-61. doi: 10.1016/j.urology.2011.09.056.


Candidate serum biomarkers for prostate adenocarcinoma identified by mRNA differences in prostate tissue and verified with protein measurements in tissue and blood.

Klee EW, Bondar OP, Goodmanson MK, Dyer RB, Erdogan S, Bergstralh EJ, Bergen HR 3rd, Sebo TJ, Klee GG.

Clin Chem. 2012 Mar;58(3):599-609. doi: 10.1373/clinchem.2011.171637. Epub 2012 Jan 12.


Sixteen-year longitudinal changes in serum prostate-specific antigen levels: the olmsted county study.

Jacobsen SJ, Jacobson DJ, McGree ME, St Sauver JL, Klee GG, Girman CJ, Lieber MM.

Mayo Clin Proc. 2012 Jan;87(1):34-40. doi: 10.1016/j.mayocp.2011.09.002.


Benign prostate specific antigen distribution and associations with urological outcomes in community dwelling black and white men.

Rhodes T, Jacobson DJ, McGree ME, St Sauver JL, Sarma AV, Girman CJ, Lieber MM, Klee GG, Demissie K, Jacobsen SJ.

J Urol. 2012 Jan;187(1):87-91. doi: 10.1016/j.juro.2011.09.061. Epub 2011 Nov 16.


Distribution and associations of [-2]proenzyme-prostate specific antigen in community dwelling black and white men.

Rhodes T, Jacobson DJ, McGree ME, St Sauver JL, Sarma AV, Girman CJ, Lieber MM, Klee GG, Demissie K, Jacobsen SJ.

J Urol. 2012 Jan;187(1):92-6. doi: 10.1016/j.juro.2011.09.060. Epub 2011 Nov 16.


Hereditary hyperferritinemia-cataract syndrome in two large multigenerational American families.

Shekunov J, de Groen PC, Lindor NM, Klee GG, Aleff RA, Wieben ED, Mohney BG.

J AAPOS. 2011 Aug;15(4):356-61. doi: 10.1016/j.jaapos.2011.03.020.


Biologic variation of a novel cardiac troponin I assay.

Vasile VC, Saenger AK, Kroning JM, Klee GG, Jaffe AS.

Clin Chem. 2011 Jul;57(7):1080-1. doi: 10.1373/clinchem.2011.162545. Epub 2011 Apr 25. No abstract available. Erratum in: Clin Chem. 2012 Mar;58(3):647.


[Establishment of outcome-related analytic performance goals].

Klee GG.

Ann Biol Clin (Paris). 2011 Mar-Apr;69(2):139-50. doi: 10.1684/abc.2011.0541. French.


A multicenter study of [-2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range.

Catalona WJ, Partin AW, Sanda MG, Wei JT, Klee GG, Bangma CH, Slawin KM, Marks LS, Loeb S, Broyles DL, Shin SS, Cruz AB, Chan DW, Sokoll LJ, Roberts WL, van Schaik RH, Mizrahi IA.

J Urol. 2011 May;185(5):1650-5. doi: 10.1016/j.juro.2010.12.032. Epub 2011 Mar 17. Erratum in: J Urol. 2011 Jul;186(1):354.


Associations between longitudinal changes in serum estrogen, testosterone, and bioavailable testosterone and changes in benign urologic outcomes.

St Sauver JL, Jacobson DJ, McGree ME, Girman CJ, Klee GG, Lieber MM, Jacobsen SJ.

Am J Epidemiol. 2011 Apr 1;173(7):787-96. doi: 10.1093/aje/kwq438. Epub 2011 Mar 2.


Glucose meter performance criteria for tight glycemic control estimated by simulation modeling.

Karon BS, Boyd JC, Klee GG.

Clin Chem. 2010 Jul;56(7):1091-7. doi: 10.1373/clinchem.2010.145367. Epub 2010 May 28.


FAVL elevation in human tumors disrupts Fanconi anemia pathway signaling and promotes genomic instability and tumor growth.

Zhang J, Zhao D, Park HK, Wang H, Dyer RB, Liu W, Klee GG, McNiven MA, Tindall DJ, Molina JR, Fei P.

J Clin Invest. 2010 May;120(5):1524-34. doi: 10.1172/JCI40908. Epub 2010 Apr 19.


Harmonization and standardization of thyroid function tests.

Klee GG.

Clin Chem. 2010 Jun;56(6):879-80. doi: 10.1373/clinchem.2010.145540. Epub 2010 Apr 8. No abstract available.


Establishment of outcome-related analytic performance goals.

Klee GG.

Clin Chem. 2010 May;56(5):714-22. doi: 10.1373/clinchem.2009.133660. Epub 2010 Mar 26. Review.


Sex and ethnic differences in 47 candidate proteomic markers of cardiovascular disease: the Mayo Clinic proteomic markers of arteriosclerosis study.

Kim CX, Bailey KR, Klee GG, Ellington AA, Liu G, Mosley TH Jr, Rehman H, Kullo IJ.

PLoS One. 2010 Feb 5;5(2):e9065. doi: 10.1371/journal.pone.0009065.


Antibody-based protein multiplex platforms: technical and operational challenges.

Ellington AA, Kullo IJ, Bailey KR, Klee GG.

Clin Chem. 2010 Feb;56(2):186-93. doi: 10.1373/clinchem.2009.127514. Epub 2009 Dec 3. Review.


Measurement and quality control issues in multiplex protein assays: a case study.

Ellington AA, Kullo IJ, Bailey KR, Klee GG.

Clin Chem. 2009 Jun;55(6):1092-9. doi: 10.1373/clinchem.2008.120717. Epub 2009 Apr 16.


Assay configuration and analytic specificity may have major effects on prediction of clinical outcomes-- implications for reference standards.

Klee GG.

Clin Chem. 2009 May;55(5):848-9. doi: 10.1373/clinchem.2009.124172. Epub 2009 Mar 19. No abstract available.


National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers.

Sturgeon CM, Duffy MJ, Stenman UH, Lilja H, Brünner N, Chan DW, Babaian R, Bast RC Jr, Dowell B, Esteva FJ, Haglund C, Harbeck N, Hayes DF, Holten-Andersen M, Klee GG, Lamerz R, Looijenga LH, Molina R, Nielsen HJ, Rittenhouse H, Semjonow A, Shih IeM, Sibley P, Sölétormos G, Stephan C, Sokoll L, Hoffman BR, Diamandis EP; National Academy of Clinical Biochemistry.

Clin Chem. 2008 Dec;54(12):e11-79. doi: 10.1373/clinchem.2008.105601.


A tissue biomarker panel predicting systemic progression after PSA recurrence post-definitive prostate cancer therapy.

Nakagawa T, Kollmeyer TM, Morlan BW, Anderson SK, Bergstralh EJ, Davis BJ, Asmann YW, Klee GG, Ballman KV, Jenkins RB.

PLoS One. 2008;3(5):e2318. doi: 10.1371/journal.pone.0002318. Epub 2008 May 28.


Quantitation of circulating tumor cells in blood samples from ovarian and prostate cancer patients using tumor-specific fluorescent ligands.

He W, Kularatne SA, Kalli KR, Prendergast FG, Amato RJ, Klee GG, Hartmann LC, Low PS.

Int J Cancer. 2008 Oct 15;123(8):1968-73. doi: 10.1002/ijc.23717.


The associations between serum sex hormones, erectile function, and sex drive: the Olmsted County Study of Urinary Symptoms and Health Status among Men.

Gades NM, Jacobson DJ, McGree ME, St Sauver JL, Lieber MM, Nehra A, Girman CJ, Klee GG, Jacobsen SJ.

J Sex Med. 2008 Sep;5(9):2209-20. doi: 10.1111/j.1743-6109.2008.00924.x. Epub 2008 Jul 4.


Challenges in translating plasma proteomics from bench to bedside: update from the NHLBI Clinical Proteomics Programs.

Gerszten RE, Accurso F, Bernard GR, Caprioli RM, Klee EW, Klee GG, Kullo I, Laguna TA, Roth FP, Sabatine M, Srinivas P, Wang TJ, Ware LB.

Am J Physiol Lung Cell Mol Physiol. 2008 Jul;295(1):L16-22. doi: 10.1152/ajplung.00044.2008. Epub 2008 May 2. Review.


Bioinformatics methods for prioritizing serum biomarker candidates.

Klee EW, Finlay JA, McDonald C, Attewell JR, Hebrink D, Dyer R, Love B, Vasmatzis G, Li TM, Beechem JM, Klee GG.

Clin Chem. 2006 Nov;52(11):2162-4. No abstract available.

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