Nmp22 核基质蛋白临床意义

【注意事项】 禁忌症

· 此检测不适用于有泌尿道留置器械（如支架）或膀胱全切除术后病人。 警告和注意事项 · 仅供体外诊断使用 · 不要使用过期试剂

· 为避免交叉污染，每个病人的尿样应使用新的滴管 · 应将尿样与使用过的检测板视为具有潜在感染性的物品 · 不要重复使用一次性的检测板，检测板用过一次后要丢弃 · 请参照当地医疗废品处理法规处理试剂盒中的剩余物品

· 在打开尿核基质蛋白22（NMP22）检测试剂盒（胶体金法）检测板包装前，请检查外包装有无撕裂，漏洞或其他开口，若有，请勿使用该检测板

· 为避免错误结果，请只使用塑料容器处理或储存尿样，切勿使用玻璃、纸质、泡沫或其他材质的容器

【参考文献】

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5. Zaak D, AG Hofstetter, R Knuchel, et al. Endoscopic detection of urinary bladder cancewith 5-aminolevulinic acid based fluorescence endoscopy. J Urol. 161:170, 1999 (abstr).

6. Frimberger D, D Zaak, A Hofstetter. Endoscopic fluorescence diagnosis and laser treatmentof transitional cell carcinoma of the bladder. Seminars in Urol Oncol. 18(4):264-272, 2000. 7. Mliss A, Hudson, HW Herr. Carcinoma in situ of the bladder. J Urol. 153:564-572, 1995. 8. Farrow GM. Urine cytology in the detection of bladder cancer: a critical approach. JOccup Med. 32:817-821, 1990.

9. Badalament RA, DK Hermansen, M Kimmel, H Gay, HW Herr, WR Fair, WF Whitmore, MR Melamed. The sensitivity of bladder wash flow cytometry, bladder wash cytology,and voided cytology in the detection of bladder carcinoma. Cancer. 60:1423, 1987.

10.Burchardt M, T Burchardt, A Shabsigh, A De La Taille, MC Benson, I Sawczuk. Currentconcepts in biomarker technology for bladder cancers. Clin Chem. 46(5):595-605,2000.

11. Brown FM. Urine cytology: It is still the gold standard for screening? Urol Clin North Am.27:25-37, 2000.

12. Khadra MH, RS Pickard, DE Neal, et al. A prospective analysis of 1930 patients withhematuria

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to evaluate current diagnostic practice. J Urol. 163:534-537, 2000.

13. Ramakumar S, J Bhuiyan, JA Besse, SG Roberts, PC Wollan, ML Blute, DJ O’Kane.Comparison of screening methods in the detection of bladder cancer. J Urol. 161:388-394, 1999. 14. Berezney R, DS Coffey. Identification of a nuclear protein matrix. Biochem Biophys Res Commun. 60:1410, 1974.

15. Fey EG, G Krochmalnic, S Penman. The non-chromatin substructures of the nucleus: theribonucleoprotein (RNP)-containing and RNP-depleted matrices analyzed by

sequentialfractionation and resinless section electron microscopy. J Cell Biol. 102:1654, 1986. 16. Pardoll DM, B Vogelstein, DS Coffey. A fixed site of DNA replication in eukaryotic cells.Cell. 19:257, 1980.

17. Kumara-Siri MH, LE Shapiro, MI Surks. Association of the 3,5,3’-triodo-L-thyroninenuclear receptor with the nuclear matrix of cultured growth hormone-producing rat pituitarytumor cells (GC cells). J Biol Chem. 261:2844, 1986.

18. Zeitlin S, A Parent, S Silverstien, A Efstratiadis. Pre-mRNA splicing and the nuclearmatrix. Mol Cell Biol. 7:111, 1987.

19. Nakayasu H, R Berezney. Mapping replication sites in the eukaryotic nucleus. J CellBiol. 108:1, 1989.

20. Berrios M, N Osheroff, PA Fisher. In situ localization of topoisomerase II, a majorpolypeptide component of the Drosophila nuclear matrix fraction. Proc Natl Acad SciUSA. 82:4142, 1985. 21. Fey EG, S Penman. Nuclear matrix proteins reflect cell type of origin in cultured humancells. Proc Natl Acad Sci USA. 85:121, 1998.

22. Lydersen BK, DE Pettijohn. Human-specific nuclear protein that associates with thepolar region of the mitotic apparatus: distribution in a human/hamster hybrid cell. Cell.22:489-499, 1980.

23. Compton DA, DW Cleveland. NuMA is required for the proper completion of mitosis. JCell Biol. 120:947-957, 1993.

24. Yang CH, M Snyder. The nuclear mitotic apparatus protein is important in the establishmentand maintenance of the bipolar mitotic spindle apparatus. Mol Biol Cell. 3:1259-1267, 1992.

25.Compton DA, I Szilak, DW Cleveland. Primary structure of NuMA, an intranuclear proteinthat defines a novel pathway for segregation of proteins at mitosis. J Cell Biol.116:1395-1408, 1992. 26.Tang TK, CC Tang, Y-L Chen, C-W Wu. Nuclear proteins of the bovine esophagealepithelium. II. The NuMA gene gives rise to multiple mRNAs and gene products reactivewith monoclonal antibody W1. J Cell Sci. 104:249-260, 1993.

27.Partin AW, RH Getzenberg, MJ CarMichael, D Vindivich, J Yoo, JI Epstein, DS Coffey.Nuclear matrix protein patterns in human benign prostatic hyperplasia and prostate cancer.Cancer Res. 53:744, 1993.

28. Landman J, Y Chang, E Kavaler, MJ Droller, B C-S Liu. Sensitivity and specificity ofNMP22, Telomerase, and BTA in the detection of human bladder cancer. Adult Urol.52(3):398-402, 1998.

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29. Sawczuk IS, B Lee. The mechanism and clinical applications of the NMP22 tumormarker immunoassay: A review. Amer Clin Lab. 1999.

30. Stampfer DS, GA Carpinito, J Rodriguez-Villanueva, LW Willsey, CP Dinney, HBGrossman, HA Fritsche, WS McDougal. Evaluation of NMP22 in the detection of transitionalcell carcinoma of the bladder. J Urol. 159:394-398, 1998.

18. Zeitlin S, A Parent, S Silverstien, A Efstratiadis. Pre-mRNA splicing and the nuclearmatrix. Mol Cell Biol. 7:111, 1987.

19. Nakayasu H, R Berezney. Mapping replication sites in the eukaryotic nucleus. J CellBiol. 108:1, 1989.

20. Berrios M, N Osheroff, PA Fisher. In situ localization of topoisomerase II, a majorpolypeptide component of the Drosophila nuclear matrix fraction. Proc Natl Acad Sci USA. 82:4142, 1985.

21. Fey EG, S Penman. Nuclear matrix proteins reflect cell type of origin in cultured humancells. Proc Natl Acad Sci USA. 85:121, 1998.

22. Lydersen BK, DE Pettijohn. Human-specific nuclear protein that associates with thepolar region of the mitotic apparatus: distribution in a human/hamster hybrid cell. Cell.22:489-499, 1980.

23. Compton DA, DW Cleveland. NuMA is required for the proper completion of mitosis. JCell Biol. 120:947-957, 1993.

24. Yang CH, M Snyder. The nuclear mitotic apparatus protein is important in the establishmentand maintenance of the bipolar mitotic spindle apparatus. Mol Biol Cell. 3:1259-1267, 1992.

25.Compton DA, I Szilak, DW Cleveland. Primary structure of NuMA, an intranuclear proteinthat defines a novel pathway for segregation of proteins at mitosis. J Cell Biol.116:1395-1408, 1992. 26.Tang TK, CC Tang, Y-L Chen, C-W Wu. Nuclear proteins of the bovine esophageal epithelium. II. The NuMA gene gives rise to multiple mRNAs and gene products reactivewith monoclonal antibody W1. J Cell Sci. 104:249-260, 1993.

27.Partin AW, RH Getzenberg, MJ CarMichael, D Vindivich, J Yoo, JI Epstein, DS Coffey.Nuclear matrix protein patterns in human benign prostatic hyperplasia and prostate cancer.Cancer Res. 53:744, 1993.

28. Landman J, Y Chang, E Kavaler, MJ Droller, B C-S Liu. Sensitivity and specificity ofNMP22, Telomerase, and BTA in the detection of human bladder cancer. Adult Urol.52(3):398-402, 1998. 29. Sawczuk IS, B Lee. The mechanism and clinical applications of the NMP22 tumor marker immunoassay: A review. Amer Clin Lab. 1999.

30. Stampfer DS, GA Carpinito, J Rodriguez-Villanueva, LW Willsey, CP Dinney, HB Grossman, HA Fritsche, WS McDougal. Evaluation of NMP22 in the detection of transitiona cell carcinoma of the bladder. J Urol. 159:394-398, 1998.

【生产企业】

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【医疗器械注册证书编号】

国食药监械（进）字2012第3402921号 【产品标准编号】 YZB/USA 2990-2012

【说明书批准日期及修改日期】 2013年2月6日

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