游离前列腺特异抗原检测试剂盒（酶联免疫法）产品说明:

【产品名称】

通用名称：游离前列腺特异抗原检测试剂盒（酶联免疫法）

英文名称：Free PSA ELISA

【预期用途】

游离前列腺特异抗原检测试剂盒用于定量测定人血清中游离前列腺特异抗原的含量。仅供科研使用，不用于体外诊断。

【背景知识】

人前列腺特异性抗原（PSA）是一种33kD的丝氨酸蛋白酶，在人血清中与α1-抗胸腺三肽（PSA-ACT）和α2-巨球蛋白（PSAAMG）呈还原性结合。还可以发现与PSA结合的微量α1-抗胰蛋白酶和α间胰蛋白酶抑制剂。任何剩余的PSA均为游离形式（f-PSA）。

目前筛查男性前列腺癌的方法利用检测主要PSA-ACT形式。4.0 ng/ml或更高水平是前列腺癌可能性的有力指标。4然而，血清PSA水平升高也可归因于良性前列腺增生和前列腺炎，导致大量假阳性筛查结果。该问题的潜在解决方案包括测定游离PSA水平。初步研究表明，前列腺癌患者的游离PSA百分比低于良性前列腺增生患者。游离血清PSA与总PSA的联合测量可提高选定的总血清PSA水平升高的男性前列腺癌筛查的特异性，从而减少不必要的前列腺活检，对癌症检出率的影响最小。

【包装规格】

96T/盒

样本量：50µl

灵敏度：1 ng/ml

保存温度：2-8℃

参考文献：

1. Christensson A, Bjork T, Nilsson O, et al. Serum Prostate Specific Antigen Complexed to α1-Antichymotrypsin As An Indicator of Prostate Cancer. J. of Urol. 150:100-105; 1993.

2. Lilja H, Christensson A, Dahlen U, et al. Prostate-specific antigen in serum occurs predominantly in complex with α-1-antichymotrypsin. Clin Chem 37:1618-1625, 1991.

3. Stenman U-H, Leinonen J, Alfthan H, Rannikko S, Tuhkanen K, Alfthan O. A complex between prostate-specific antigen and α-1-antichymotrypsin is the major form of prostate-specific antigen in serum of patients with prostate cancer: assay of the complex improves clinical sensitivity for cancer. Cancer Res. 51:222-226, 1991.

4. Catalona WJ, Smith DS, Ratliff TL, Basler JW. Detection of organ-confined prostate cancer is increased through prostate-specific antigen-based screening. JAMA. 270:948-954, 1993. 5. Stamey TA, Yang N Hay AR, McNeal JE, Freiha, FS, Redwine E. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med. 317-: 909-916, 1987.

6. Junker R, Brandt B, Zechel C, and Assmann, G. Comparison of Prostate-specific antigen (PSA) measured by four combinations of free-PSA and total PSA assays. Clinical Chemistry 43:1588-1594, 1997.

7. Luderer AA, Chen Y-T, Soriano TF, et al. Measurements of the proportion of free to total prostate-Specific antigen improves diagnostic performance of prostate-specific antigen in the diagnostic gray zone of total prostate-specific antigen. Urology 46:187-194, 1995.

8. Carter HB, Pearson JD, Metter J, et al. Longitudinal evaluation of prostate-specific antigen levels in men with and without prostate disease. JAMA. 267:2215-2220, 1992.

9. Smith DS, Catalona WJ. Rate of change in serum prostate-specific antigen levels as a method for prostate cancer detection. J Urol. 152:1163-1167, 1994

10. Benson MC, Whang IS, Pantuck A, et al. Prostate specific antigen density: a means of distinguishing benign prostatic hypertrophy and prostate cancer. J Urol. 147:815-816, 1992.

11. Catalona WJ, Hudson MA, and Scardino PT, et al. Selection of optimal prostate specific antigen cut-offs for early detection of prostate cancer: receiver operating characteristic curves. J Urol. 152:2037-2042, 1994.

12. Smith DS, Catalona WJ. The nature of prostate cancer detected through prostate specific antigen based screening. J Urol. 152:1732-1736, 1994.

13. Catalona, et al. evaluation of Percentage of Free Serum Prostate-Specific Antigen to Improve Specificity of Prostate Cancer Screening. JAMA 274:1214, 1995.

14. Vashi AR, Wojno KJ, Henricks W, et al: Determination of the “reflex range” and appropriate cutpoints for percent free-PSA in 413 men referred for prostatic evaluation using the AxSYM system. Urology 49:19-27, 1997.

15. Bangma, CH, Kranse R, Blijenberg B, et al: The value of screening tests in the detection of prostate cancer. Part I: Results of a retrospective evaluation of 1726 men. Urol. 46:773-778, 1995.

16. Yemoto CM, Nolley R, Prestigiacomo AF, et al: Free (f) and total (t) PSA density in patients with prostate cancer (CaP) and benign prostatic hyperplasia (BPH). J Urol 155:347A, 1996. 17. Bangma, CH, Kranse R, Blijenberg B, et al: The value of screening tests in the detection of prostate cancer. Part II: Retrospective analysis of free-total prostate-specific analysis ration, age-specific reference ranges, and PSA density. Urol 46:779-785, 1995.

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