Aim: To evaluate the use of free/total prostate specific antigen ratio (fPSA/tPSA ratio) in improving the early diagnosis of prostate cancer. Methods: The fPSA/tPSA ratio in the serum was analyzed in 187 men with tPSA...Aim: To evaluate the use of free/total prostate specific antigen ratio (fPSA/tPSA ratio) in improving the early diagnosis of prostate cancer. Methods: The fPSA/tPSA ratio in the serum was analyzed in 187 men with tPSA ranging between 4.0 and 20.0 μg/L. All of them underwent ultrasound guided sextant prostatic biopsy. The results were calculated by SPSS 10.0 software. Results: (1) When the tPSA was within the ranges of 4.0 - 10.0 and 10.0 -20.0 μg/L, the prostate cancer detection rate was 18.1 % and 22.5 %, respectively; (2) The area under the curve (AUC) was bigger in fPSA/tPSA than in tPSA (P<0.05) in all the men; (3) When the cut off value of fPSA/tPSA ratio was set at 0.25 and the tPSA at 4.0 - 10.0 μg/L and 10.0 - 20.0 μg/L, the diagnostic sensitivity of tPSA was 90.5 % and 87.5 %, respectively. Thus at the tPSA ranges of 4.0 - 10.0 and 10.0 - 20.0 μg/L, 26.7 % and 11.3 % of biopsies could be avoided, respectively. Conclusion: The use of fPSA/tPSA ratio can improve the prostate cancer detection rate and reduce unnecessary biopsies when tPSA is within the range of 4.0 - 20.0 μg/L.展开更多
To measure the percent of free prostate specific antigen (fPSA) among men without prostate diseases in Xi'an area, and to study the relationship of percent fPSA with age and pathological grade, clinical stage of pr...To measure the percent of free prostate specific antigen (fPSA) among men without prostate diseases in Xi'an area, and to study the relationship of percent fPSA with age and pathological grade, clinical stage of prostate cancer (PCa) with percent fPSA, and to analyze the difference between the data in China and the.overseas data to determine appropriate reference range for Chinese male. Methods: A total of 713 participants were enrolled into the study, with PSA, fPSA in serum measured and the percent fPSA calculated. Out of 713 cases, 679 without prostate diseases were divided into 5 groups by age, and then the relationships of PSA, fPSA and percent fPSA with age were studied, respectively. The relationship of pathological grade and clinical stage with percent fPSA of the 34 participants with PCa was also studied. With the help of the related data of men without prostate disease, the appropriate reference range for Chinese male was established. Results: The increases in PSA or fPSA were correlated with age, while there was no significant correlation between age and percent fPSA. The percent fPSA was also correlated with pathological grade and clinical stage of PCa. The percent fPSA of men without prostate disease in Xi'an area was significandy lower than that in the related overseas data. The reference range of percent fPSA for Chinese male was≥ 15%. Conclusion: Percent fPSA might be more useful than PSA in the detection of prostate cancer. As the percent fPSA is decreased, the pathological grade is decreased, and the clinical stage is increased, the malignant degree is increased. The reference range of ≥15% is more appropriate for Chinese male.展开更多
Aim:To assess the efficacy and limitation of free/total prostate-specific antigen ratio(f/tPSA)at a single institution in Japan,focusing on the avoidance of pointless prostate biopsies.Methods:In total,631 men between...Aim:To assess the efficacy and limitation of free/total prostate-specific antigen ratio(f/tPSA)at a single institution in Japan,focusing on the avoidance of pointless prostate biopsies.Methods:In total,631 men between 44 and 93 years old(mean 69.8 years)with elevated PSA underwent power-Doppler ultrasoundgraphy-guided transrectal 10-core prostate biopsies at Niigata Cancer Center Hospital,and their histological features were investigated with total PSA (tPSA)and f/tPSA.Results:PCa was detected in 126 of 134 patients(94.3%)with tPSA of 26 ng/mL or higher.The detection rate was 59.4% for tPSA of 21-25 ng/mL,followed by 39.2% for 16-20 ng/mL,30.0% for 11-15 ng/mL, 20.0% for 4.1-10 ng/mL and 7.6% for≤4.0 ng/mL,f/tPSA of the PCa group was significantly lower than that of non-malignamt disorders in any tPSA ranges(mean 0.122 vs.0.160,P<0.001).Receiver-operating characteristics analyses showed that f/tPSA(AUC:0.664)performed more valuably than tPSA(AUC:0.559)in patients with tPSA between 3.0-10 ng/mL(P<0.01).Although f/tPSA of 0.250 for the cut-off value might miss 1.8% PCa patients,it potentially spares 9.2% of unnecessary biopsies.Conclusion:f/tPSA is more valuable compared with tPSA alone for the prediction of the occurrence of PCa.We recommend 0.250 as the cut-off value for f/tPSA in PCa screening for Asian men having so-called grey-zone tPSA.(Asian J Androl 2006 Jul;8:429-434)展开更多
Objective: To evaluate the efficacy of endorectal Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spetroscopic Imaging (MRSI) combined with total prostate-specific antigen (tPSA) and free prostate-specific ant...Objective: To evaluate the efficacy of endorectal Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spetroscopic Imaging (MRSI) combined with total prostate-specific antigen (tPSA) and free prostate-specific antigen (fPSA) in selecting candidates for biopsy. Subjects and Methods: 246 patients with elevated tPSA (median: 7.81 ng/ml) underwent endorectal MRI and MRSI before Transrectal Ultrasound (TRUS) biopsy (10 peripheral + 2 central cores);patients with positive biopsies were treated with radical intention;those with negative biopsies were followed up and underwent MRSI before each additional biopsy if tPSA rose persistently. Mean follow-up: 27.6 months. We compared MRI, MRSI, tPSA, and fPSA with histopathology by sextant and determined the association between the Gleason score and MRI and MRSI. We determined the most accurate combination to detect prostate cancer (PCa) using receiver operating curves;we estimated the odds ratios (OR) and calculated sensitivity, specificity, and positive and negative predictive values. Results: No difference in tPSA was found between patients with and without PCa (p = 0.551). In the peripheral zone, the risk of PCa increased with MRSI grade;patients with high-grade MRSI had the greatest risk of PCa over time (OR = 328.6);the model including MRI, MRSI, tPSA, and fPSA was more accurate (Area under Curve: AUC = 95.7%) than MRI alone (AUC = 85.1%) or fPSA alone (AUC = 78.1%), but not than MRSI alone (94.5%). In the transitional zone, the model was less accurate (AUC = 84.4%). The association (p = 0.005) between MRSI and Gleason score was significant in both zones. Conclusions: MRSI is useful in patients with elevated tPSA. High-grade MRSI lesions call for repeated biopsies. Men with negative MRSI may forgo further biopsies because a significantly high Gleason lesion is very unlikely.展开更多
Percent free prostatic-specific antigen (%fPSA) has been introduced as a tool to avoid unnecessary biopsies in patients with a serum PSA level of 4.0-10.0 ng ml^-1, however, it remains controversial whether %fPSA is...Percent free prostatic-specific antigen (%fPSA) has been introduced as a tool to avoid unnecessary biopsies in patients with a serum PSA level of 4.0-10.0 ng ml^-1, however, it remains controversial whether %fPSA is effective in PSA range of 10.1-20.0 ng ml^-1 in both Chinese and Western population. In this study, the diagnostic performance of %fPSA and serum PSA in predicting prostate cancer (PCa) and high-grade PCa (HGPCa) was analyzed in a multi-center biopsy cohort of 5915 consecutive Chinese patients who underwent prostate biopsy in 22 hospitals across China from January 1, 2010 to December 31, 2013. The indication for biopsy was PSA〉4.0 ng ml^-1 or/and suspicious digital rectal examination. Total and free serum PSA determinations were performed by three types of electrochemiluminescence immunoassays with recalibration to the World Health Organization standards. The diagnostics accuracy of PSA, %fPSA and %fPSA in combination with PSA (%fPSA + PSA) was determined by the area under the receivers operating characteristic curve (AUC). %fPSA was more effective than PSA in men aged ≥60 years old. The AUC was 0.584 and 0.635 in men aged ≥60 years old with a PSA of 4.0-10.0 ng ml^-1 and 10.1-20.0 ng ml^-1, respectively. The AUC of %fPSA was superior to that of PSA in predicting HGPCa in patients ≥60 years old in these two PSA range. Our results indicated that %fPSA is both statistically effective and clinical applicable to predict prostate biopsy outcome in Chinese patients aged ≥60 years old with a PSA of 4.0-10.0 ng ml^-1 and 10.1-20.0 ng ml^-1.展开更多
Prostate-specific antigen (PSA) testing for the early diagnosis of prostate cancer has led to a decrease in cancer mortality. However, the high prevalence of low-grade prostate cancer and its long natural history, c...Prostate-specific antigen (PSA) testing for the early diagnosis of prostate cancer has led to a decrease in cancer mortality. However, the high prevalence of low-grade prostate cancer and its long natural history, competing causes of death in older men and treatment patterns of prostate cancer, have led to dramatic overtreatment of the disease. Improved markers of prostate cancer lethality are needed to reduce the overtreatment of prostate cancer that leads to a reduced quality of life without extending life for a high proportion of men. The PSA level prior to treatment is routinely used in multivariable models to predict prostate cancer aggressiveness. PSA isoforms and PSA kinetics have been associated with more aggressive phenotypes, but are not routinely employed as part of prediction tools prior to treatment. PSA kinetics is a valuable marker of lethality post treatment and routinely used in determininE the need for salva=e theraov.展开更多
目的探究腹腔镜前列腺癌根治术对局限性前列腺癌患者尿动力学及血清游离前列腺特异抗原百分率(FPSAR)的影响。方法选择局限性前列腺癌患者87例,随机数表法分为研究组与对照组。研究组患者44例给予腹腔镜前列腺癌根治术治疗;对照组患者4...目的探究腹腔镜前列腺癌根治术对局限性前列腺癌患者尿动力学及血清游离前列腺特异抗原百分率(FPSAR)的影响。方法选择局限性前列腺癌患者87例,随机数表法分为研究组与对照组。研究组患者44例给予腹腔镜前列腺癌根治术治疗;对照组患者43例给予开放性前列腺癌根治术治疗,观察2组术后国际前列腺症状评分(IPSS)、尿控率、尿动力学指标和FPSAR水平差异。结果术后,2组IPSS评分、膀胱顺应性(BC)、逼尿肌不稳定(DI)率、残余尿量(PVR)、前列腺特异抗原(t-PSA)、游离前列腺特异抗原(f-PSA)水平均降低,最大尿流率(Qmax)、最大尿流率时逼尿肌压力(Pdet at Qmax)、FPSAR均升高(P<0.05)。研究组IPSS评分、BC、DI、PVR水平均低于对照组,Qmax、Pdet at Qmax水平均高于对照组(P<0.05),2组t-PSA、f-PSA、FPSAR水平比较,差异无统计学意义(P>0.05)。研究组术后1个月、2个月、3个月、4个月尿控率均显著高于对照组(P<0.05)。结论腹腔镜前列腺癌根治术治疗局限性前列腺癌,可有效改善尿动力学指标,提高FPSAR水平,治疗效果较好。展开更多
In Western countries, clinical trials on prostate cancer screening demonstrated a limited benefit for patient survival. In the Asia-Pacific region, including Japan, the rate of prostate-specific antigen (PSA) testin...In Western countries, clinical trials on prostate cancer screening demonstrated a limited benefit for patient survival. In the Asia-Pacific region, including Japan, the rate of prostate-specific antigen (PSA) testing remains very low compared with Western countries, and the benefits of population-based screening remain unclear. This review describes the current status of population screening and diagnosis for prostate cancer in Japan and discusses the efficacy of population screening for the Asian population. Since the 1990s, screening systems have been administered by each municipal government in Japan, and decreases in the prostate cancer mortality rate are expected in some regions where the exposure rate to PSA screening has increased markedly. A population-based screening cohort revealed that the proportion of metastatic disease in cancer detected by screening gradually decreased according to the increased exposure rate, and a decreasing trend in the proportion of cancer with high serum PSA levels after population screening was started. The prognosis of the prostate cancer detected by population screening was demonstrated to be more favorable than those diagnosed outside of the population screening. Recent results in screening cohorts demonstrated the efficacy of PSA. These recent evidences regarding population-based screening in Japan may contribute to establishing the optimal prostate cancer screeninK system in Asian individuals.展开更多
目的建立产生抗人游离前列腺特异抗原单克隆抗体(f-PSA m Ab)的细胞株,获得抗体后建立抗人f-PSA化学发光免疫分析法(CLIA)并进行应用。方法采用杂交瘤技术获得2株稳定分泌抗f-PSA m Ab的细胞株,将细胞株用转瓶扩大培养并将上清液采用亲...目的建立产生抗人游离前列腺特异抗原单克隆抗体(f-PSA m Ab)的细胞株,获得抗体后建立抗人f-PSA化学发光免疫分析法(CLIA)并进行应用。方法采用杂交瘤技术获得2株稳定分泌抗f-PSA m Ab的细胞株,将细胞株用转瓶扩大培养并将上清液采用亲和纯化法获得抗体,ELISA测定抗体效价、特异性及表位,表面等离子共振法测抗体亲和力;建立双抗体夹心CLIA,采用标准曲线定量法对该体系进行分析性能评估,同时对426例临床血清样本进行检测[其中130例的总PSA水平在(4~10) ng/mL,为"诊断灰区"],评价该试剂与罗氏试剂的检测一致性。结果获得抗人f-PSA m Ab的杂交瘤细胞株(f-10-1、f-14-1)。用f-10-1和f-14-1建立的CLIA的检测范围为(0. 1~30) ng/mL,灵敏度为0. 05 ng/mL,检测结果的相对偏差均在±5%内,与癌胚抗原(CEA)、甲胎蛋白(AFP)及结合态PSA(c-PSA)无交叉反应,该试剂与罗氏试剂相关系数达到0. 99,灰区样本阳性符合率、阴性符合率、总符合率均高于90%。结论成功制备了抗人f-PSA m Ab,建立了特异性定量检测人f-PSA的双抗体夹心CLIA。展开更多
文摘Aim: To evaluate the use of free/total prostate specific antigen ratio (fPSA/tPSA ratio) in improving the early diagnosis of prostate cancer. Methods: The fPSA/tPSA ratio in the serum was analyzed in 187 men with tPSA ranging between 4.0 and 20.0 μg/L. All of them underwent ultrasound guided sextant prostatic biopsy. The results were calculated by SPSS 10.0 software. Results: (1) When the tPSA was within the ranges of 4.0 - 10.0 and 10.0 -20.0 μg/L, the prostate cancer detection rate was 18.1 % and 22.5 %, respectively; (2) The area under the curve (AUC) was bigger in fPSA/tPSA than in tPSA (P<0.05) in all the men; (3) When the cut off value of fPSA/tPSA ratio was set at 0.25 and the tPSA at 4.0 - 10.0 μg/L and 10.0 - 20.0 μg/L, the diagnostic sensitivity of tPSA was 90.5 % and 87.5 %, respectively. Thus at the tPSA ranges of 4.0 - 10.0 and 10.0 - 20.0 μg/L, 26.7 % and 11.3 % of biopsies could be avoided, respectively. Conclusion: The use of fPSA/tPSA ratio can improve the prostate cancer detection rate and reduce unnecessary biopsies when tPSA is within the range of 4.0 - 20.0 μg/L.
文摘To measure the percent of free prostate specific antigen (fPSA) among men without prostate diseases in Xi'an area, and to study the relationship of percent fPSA with age and pathological grade, clinical stage of prostate cancer (PCa) with percent fPSA, and to analyze the difference between the data in China and the.overseas data to determine appropriate reference range for Chinese male. Methods: A total of 713 participants were enrolled into the study, with PSA, fPSA in serum measured and the percent fPSA calculated. Out of 713 cases, 679 without prostate diseases were divided into 5 groups by age, and then the relationships of PSA, fPSA and percent fPSA with age were studied, respectively. The relationship of pathological grade and clinical stage with percent fPSA of the 34 participants with PCa was also studied. With the help of the related data of men without prostate disease, the appropriate reference range for Chinese male was established. Results: The increases in PSA or fPSA were correlated with age, while there was no significant correlation between age and percent fPSA. The percent fPSA was also correlated with pathological grade and clinical stage of PCa. The percent fPSA of men without prostate disease in Xi'an area was significandy lower than that in the related overseas data. The reference range of percent fPSA for Chinese male was≥ 15%. Conclusion: Percent fPSA might be more useful than PSA in the detection of prostate cancer. As the percent fPSA is decreased, the pathological grade is decreased, and the clinical stage is increased, the malignant degree is increased. The reference range of ≥15% is more appropriate for Chinese male.
文摘Aim:To assess the efficacy and limitation of free/total prostate-specific antigen ratio(f/tPSA)at a single institution in Japan,focusing on the avoidance of pointless prostate biopsies.Methods:In total,631 men between 44 and 93 years old(mean 69.8 years)with elevated PSA underwent power-Doppler ultrasoundgraphy-guided transrectal 10-core prostate biopsies at Niigata Cancer Center Hospital,and their histological features were investigated with total PSA (tPSA)and f/tPSA.Results:PCa was detected in 126 of 134 patients(94.3%)with tPSA of 26 ng/mL or higher.The detection rate was 59.4% for tPSA of 21-25 ng/mL,followed by 39.2% for 16-20 ng/mL,30.0% for 11-15 ng/mL, 20.0% for 4.1-10 ng/mL and 7.6% for≤4.0 ng/mL,f/tPSA of the PCa group was significantly lower than that of non-malignamt disorders in any tPSA ranges(mean 0.122 vs.0.160,P<0.001).Receiver-operating characteristics analyses showed that f/tPSA(AUC:0.664)performed more valuably than tPSA(AUC:0.559)in patients with tPSA between 3.0-10 ng/mL(P<0.01).Although f/tPSA of 0.250 for the cut-off value might miss 1.8% PCa patients,it potentially spares 9.2% of unnecessary biopsies.Conclusion:f/tPSA is more valuable compared with tPSA alone for the prediction of the occurrence of PCa.We recommend 0.250 as the cut-off value for f/tPSA in PCa screening for Asian men having so-called grey-zone tPSA.(Asian J Androl 2006 Jul;8:429-434)
文摘Objective: To evaluate the efficacy of endorectal Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spetroscopic Imaging (MRSI) combined with total prostate-specific antigen (tPSA) and free prostate-specific antigen (fPSA) in selecting candidates for biopsy. Subjects and Methods: 246 patients with elevated tPSA (median: 7.81 ng/ml) underwent endorectal MRI and MRSI before Transrectal Ultrasound (TRUS) biopsy (10 peripheral + 2 central cores);patients with positive biopsies were treated with radical intention;those with negative biopsies were followed up and underwent MRSI before each additional biopsy if tPSA rose persistently. Mean follow-up: 27.6 months. We compared MRI, MRSI, tPSA, and fPSA with histopathology by sextant and determined the association between the Gleason score and MRI and MRSI. We determined the most accurate combination to detect prostate cancer (PCa) using receiver operating curves;we estimated the odds ratios (OR) and calculated sensitivity, specificity, and positive and negative predictive values. Results: No difference in tPSA was found between patients with and without PCa (p = 0.551). In the peripheral zone, the risk of PCa increased with MRSI grade;patients with high-grade MRSI had the greatest risk of PCa over time (OR = 328.6);the model including MRI, MRSI, tPSA, and fPSA was more accurate (Area under Curve: AUC = 95.7%) than MRI alone (AUC = 85.1%) or fPSA alone (AUC = 78.1%), but not than MRSI alone (94.5%). In the transitional zone, the model was less accurate (AUC = 84.4%). The association (p = 0.005) between MRSI and Gleason score was significant in both zones. Conclusions: MRSI is useful in patients with elevated tPSA. High-grade MRSI lesions call for repeated biopsies. Men with negative MRSI may forgo further biopsies because a significantly high Gleason lesion is very unlikely.
文摘Percent free prostatic-specific antigen (%fPSA) has been introduced as a tool to avoid unnecessary biopsies in patients with a serum PSA level of 4.0-10.0 ng ml^-1, however, it remains controversial whether %fPSA is effective in PSA range of 10.1-20.0 ng ml^-1 in both Chinese and Western population. In this study, the diagnostic performance of %fPSA and serum PSA in predicting prostate cancer (PCa) and high-grade PCa (HGPCa) was analyzed in a multi-center biopsy cohort of 5915 consecutive Chinese patients who underwent prostate biopsy in 22 hospitals across China from January 1, 2010 to December 31, 2013. The indication for biopsy was PSA〉4.0 ng ml^-1 or/and suspicious digital rectal examination. Total and free serum PSA determinations were performed by three types of electrochemiluminescence immunoassays with recalibration to the World Health Organization standards. The diagnostics accuracy of PSA, %fPSA and %fPSA in combination with PSA (%fPSA + PSA) was determined by the area under the receivers operating characteristic curve (AUC). %fPSA was more effective than PSA in men aged ≥60 years old. The AUC was 0.584 and 0.635 in men aged ≥60 years old with a PSA of 4.0-10.0 ng ml^-1 and 10.1-20.0 ng ml^-1, respectively. The AUC of %fPSA was superior to that of PSA in predicting HGPCa in patients ≥60 years old in these two PSA range. Our results indicated that %fPSA is both statistically effective and clinical applicable to predict prostate biopsy outcome in Chinese patients aged ≥60 years old with a PSA of 4.0-10.0 ng ml^-1 and 10.1-20.0 ng ml^-1.
文摘Prostate-specific antigen (PSA) testing for the early diagnosis of prostate cancer has led to a decrease in cancer mortality. However, the high prevalence of low-grade prostate cancer and its long natural history, competing causes of death in older men and treatment patterns of prostate cancer, have led to dramatic overtreatment of the disease. Improved markers of prostate cancer lethality are needed to reduce the overtreatment of prostate cancer that leads to a reduced quality of life without extending life for a high proportion of men. The PSA level prior to treatment is routinely used in multivariable models to predict prostate cancer aggressiveness. PSA isoforms and PSA kinetics have been associated with more aggressive phenotypes, but are not routinely employed as part of prediction tools prior to treatment. PSA kinetics is a valuable marker of lethality post treatment and routinely used in determininE the need for salva=e theraov.
文摘目的探究腹腔镜前列腺癌根治术对局限性前列腺癌患者尿动力学及血清游离前列腺特异抗原百分率(FPSAR)的影响。方法选择局限性前列腺癌患者87例,随机数表法分为研究组与对照组。研究组患者44例给予腹腔镜前列腺癌根治术治疗;对照组患者43例给予开放性前列腺癌根治术治疗,观察2组术后国际前列腺症状评分(IPSS)、尿控率、尿动力学指标和FPSAR水平差异。结果术后,2组IPSS评分、膀胱顺应性(BC)、逼尿肌不稳定(DI)率、残余尿量(PVR)、前列腺特异抗原(t-PSA)、游离前列腺特异抗原(f-PSA)水平均降低,最大尿流率(Qmax)、最大尿流率时逼尿肌压力(Pdet at Qmax)、FPSAR均升高(P<0.05)。研究组IPSS评分、BC、DI、PVR水平均低于对照组,Qmax、Pdet at Qmax水平均高于对照组(P<0.05),2组t-PSA、f-PSA、FPSAR水平比较,差异无统计学意义(P>0.05)。研究组术后1个月、2个月、3个月、4个月尿控率均显著高于对照组(P<0.05)。结论腹腔镜前列腺癌根治术治疗局限性前列腺癌,可有效改善尿动力学指标,提高FPSAR水平,治疗效果较好。
文摘In Western countries, clinical trials on prostate cancer screening demonstrated a limited benefit for patient survival. In the Asia-Pacific region, including Japan, the rate of prostate-specific antigen (PSA) testing remains very low compared with Western countries, and the benefits of population-based screening remain unclear. This review describes the current status of population screening and diagnosis for prostate cancer in Japan and discusses the efficacy of population screening for the Asian population. Since the 1990s, screening systems have been administered by each municipal government in Japan, and decreases in the prostate cancer mortality rate are expected in some regions where the exposure rate to PSA screening has increased markedly. A population-based screening cohort revealed that the proportion of metastatic disease in cancer detected by screening gradually decreased according to the increased exposure rate, and a decreasing trend in the proportion of cancer with high serum PSA levels after population screening was started. The prognosis of the prostate cancer detected by population screening was demonstrated to be more favorable than those diagnosed outside of the population screening. Recent results in screening cohorts demonstrated the efficacy of PSA. These recent evidences regarding population-based screening in Japan may contribute to establishing the optimal prostate cancer screeninK system in Asian individuals.
文摘目的建立产生抗人游离前列腺特异抗原单克隆抗体(f-PSA m Ab)的细胞株,获得抗体后建立抗人f-PSA化学发光免疫分析法(CLIA)并进行应用。方法采用杂交瘤技术获得2株稳定分泌抗f-PSA m Ab的细胞株,将细胞株用转瓶扩大培养并将上清液采用亲和纯化法获得抗体,ELISA测定抗体效价、特异性及表位,表面等离子共振法测抗体亲和力;建立双抗体夹心CLIA,采用标准曲线定量法对该体系进行分析性能评估,同时对426例临床血清样本进行检测[其中130例的总PSA水平在(4~10) ng/mL,为"诊断灰区"],评价该试剂与罗氏试剂的检测一致性。结果获得抗人f-PSA m Ab的杂交瘤细胞株(f-10-1、f-14-1)。用f-10-1和f-14-1建立的CLIA的检测范围为(0. 1~30) ng/mL,灵敏度为0. 05 ng/mL,检测结果的相对偏差均在±5%内,与癌胚抗原(CEA)、甲胎蛋白(AFP)及结合态PSA(c-PSA)无交叉反应,该试剂与罗氏试剂相关系数达到0. 99,灰区样本阳性符合率、阴性符合率、总符合率均高于90%。结论成功制备了抗人f-PSA m Ab,建立了特异性定量检测人f-PSA的双抗体夹心CLIA。