Background: Prostate cancer (PCa) is considered one of the major health threats facing males in Sudan. Prostate-specific antigen (PSA) test is the most important laboratory test used in the diagnosis of prostate cance...Background: Prostate cancer (PCa) is considered one of the major health threats facing males in Sudan. Prostate-specific antigen (PSA) test is the most important laboratory test used in the diagnosis of prostate cancer, the main disadvantage of PSA is its limited specificity, which triggered a lot of interest in development, more research on other markers such as serum human kallikrein-2 (KLK-2) and free prostate specific antigen (fPSA). Objectives: To evaluate the validity of serum kallikrein-2 (KLK-2) and free prostate specific antigen (fPSA) in the early detection of prostate cancer among Sudanese patients. Method: In this study seventy men were considered as a case subject, who were diagnosed as cancer prostate at Gezira Hospital for Renal Disease and Surgery (GHRDS), Sudan during the period February 2018 to July 2019. Randomly selected sixty patients of BPH patients and forty-five apparently healthy men as control subject. KLK-2, fPSA and PSA estimations were performed from serum samples using the principle of Enzyme Linked Immunosorbent Assay (ELISA). Results: The results revealed a highly significant difference between the serum levels individual biomarkers (KLK-2, fPSA, PSA) and multiple biomarkers (fPSA/PSA, KLK-2/fPSA, KLK-2/PSA) for patients with prostate cancer when compared with the control groups. Furthermore, the fPSA/PSA ratio was lower in the patients with prostate cancer (P value = 0.00) than in the control group, the fPSA/PSA ratio showed that best accuracy to differentiate prostate cancer from control group, fPSA cut-off value was found to be more than (18 ng/ml), with sensitivity (93%), specificity (80%), and odds ratio (55). Conclusions: The use of multiple biomarkers rather than individual biomarkers especially fPSA/PSA ratio improves the specificity as well as maintenance of higher sensitivity for early diagnosis of the prostate cancer.展开更多
目的探讨前列腺相关标志物总前列腺特异性抗原(total prostate specific antigen,tPSA)和游离前列腺特异性抗原(free prostate specific antigen,fPSA)在全自动生化分析系统贝克曼(AU5811)、全自动化学发光分析系统贝克曼(DXI800)和迈瑞...目的探讨前列腺相关标志物总前列腺特异性抗原(total prostate specific antigen,tPSA)和游离前列腺特异性抗原(free prostate specific antigen,fPSA)在全自动生化分析系统贝克曼(AU5811)、全自动化学发光分析系统贝克曼(DXI800)和迈瑞CL-2000i中检测结果的相关性。方法AU5811采用胶乳免疫比浊法,DXI800、CL-2000i采用磁微粒化学发光法,检测不同浓度tPSA和fPSA的结果,依据CNAS-GL037临床化学定量检验程序性能验证指南要求,按照WS/T492-2016规定的方法,对用胶乳免疫比浊法在AU5811上检测tPSA和fPSA的结果进行可比性验证,选择5个水平室间质控品202211~202215,每一样本重复检测3次,计算均值和偏倚,用试剂盒自带2水平质控做精密度评价。各系统分别测定253例确诊前列腺增生患者的血液tPSA和fPSA水平,评价AU5811检测系统与DXI800、CL-2000i检测系统结果的相关性。结果AU5811检测tPSA和fPSA可比性验证符合要求,tPSA 5水平的偏倚分别为-8.25%、4.78%、3.55%、-5.88%、-3.46%,fPSA 5水平的偏倚分别为-10.00%、-8.11%、3.72%、10.59%、-7.04%;精密度验证tPSA水平1批内CV为5.43%、总CV为5.42%,水平2批内CV为3.16%、总CV为3.35%;fPSA水平1批内CV为8.91%、总CV为8.94%,水平2批内CV为6.82%、总CV为6.99%;其CV值均低于试剂说明书规定CV(10%)。253例确诊前列腺增生患者的血液tPSA和fPSA在AU5811检测结果分别与DXI800和CL-2000i上检测结果比较,其相关系数tPSA为0.977、0.945,fPSA相关系数为0.951、0.918,在0.01水平(双侧)上显著相关。结论贝克曼AU5811系统检测tPSA和fPSA可比性验证符合要求,批内精密度与总精密度均小于试剂盒说明书要求,验证通过,AU5811系统与DXI800、CL-2000i检测tPSA和fPSA结果比较具有较好的相关性。展开更多
文摘Background: Prostate cancer (PCa) is considered one of the major health threats facing males in Sudan. Prostate-specific antigen (PSA) test is the most important laboratory test used in the diagnosis of prostate cancer, the main disadvantage of PSA is its limited specificity, which triggered a lot of interest in development, more research on other markers such as serum human kallikrein-2 (KLK-2) and free prostate specific antigen (fPSA). Objectives: To evaluate the validity of serum kallikrein-2 (KLK-2) and free prostate specific antigen (fPSA) in the early detection of prostate cancer among Sudanese patients. Method: In this study seventy men were considered as a case subject, who were diagnosed as cancer prostate at Gezira Hospital for Renal Disease and Surgery (GHRDS), Sudan during the period February 2018 to July 2019. Randomly selected sixty patients of BPH patients and forty-five apparently healthy men as control subject. KLK-2, fPSA and PSA estimations were performed from serum samples using the principle of Enzyme Linked Immunosorbent Assay (ELISA). Results: The results revealed a highly significant difference between the serum levels individual biomarkers (KLK-2, fPSA, PSA) and multiple biomarkers (fPSA/PSA, KLK-2/fPSA, KLK-2/PSA) for patients with prostate cancer when compared with the control groups. Furthermore, the fPSA/PSA ratio was lower in the patients with prostate cancer (P value = 0.00) than in the control group, the fPSA/PSA ratio showed that best accuracy to differentiate prostate cancer from control group, fPSA cut-off value was found to be more than (18 ng/ml), with sensitivity (93%), specificity (80%), and odds ratio (55). Conclusions: The use of multiple biomarkers rather than individual biomarkers especially fPSA/PSA ratio improves the specificity as well as maintenance of higher sensitivity for early diagnosis of the prostate cancer.
文摘目的探讨前列腺相关标志物总前列腺特异性抗原(total prostate specific antigen,tPSA)和游离前列腺特异性抗原(free prostate specific antigen,fPSA)在全自动生化分析系统贝克曼(AU5811)、全自动化学发光分析系统贝克曼(DXI800)和迈瑞CL-2000i中检测结果的相关性。方法AU5811采用胶乳免疫比浊法,DXI800、CL-2000i采用磁微粒化学发光法,检测不同浓度tPSA和fPSA的结果,依据CNAS-GL037临床化学定量检验程序性能验证指南要求,按照WS/T492-2016规定的方法,对用胶乳免疫比浊法在AU5811上检测tPSA和fPSA的结果进行可比性验证,选择5个水平室间质控品202211~202215,每一样本重复检测3次,计算均值和偏倚,用试剂盒自带2水平质控做精密度评价。各系统分别测定253例确诊前列腺增生患者的血液tPSA和fPSA水平,评价AU5811检测系统与DXI800、CL-2000i检测系统结果的相关性。结果AU5811检测tPSA和fPSA可比性验证符合要求,tPSA 5水平的偏倚分别为-8.25%、4.78%、3.55%、-5.88%、-3.46%,fPSA 5水平的偏倚分别为-10.00%、-8.11%、3.72%、10.59%、-7.04%;精密度验证tPSA水平1批内CV为5.43%、总CV为5.42%,水平2批内CV为3.16%、总CV为3.35%;fPSA水平1批内CV为8.91%、总CV为8.94%,水平2批内CV为6.82%、总CV为6.99%;其CV值均低于试剂说明书规定CV(10%)。253例确诊前列腺增生患者的血液tPSA和fPSA在AU5811检测结果分别与DXI800和CL-2000i上检测结果比较,其相关系数tPSA为0.977、0.945,fPSA相关系数为0.951、0.918,在0.01水平(双侧)上显著相关。结论贝克曼AU5811系统检测tPSA和fPSA可比性验证符合要求,批内精密度与总精密度均小于试剂盒说明书要求,验证通过,AU5811系统与DXI800、CL-2000i检测tPSA和fPSA结果比较具有较好的相关性。
