使用Hybritech和世界卫生组织校准法对总前列腺特异抗原（PSA）和游离PSA的三种检测方法的比较
Comparison of Three Assays for Total and Free PSA Using Hybritech and WHO Calibrations.
作者信息
Garrido Manuel M, Marta José C, Ribeiro Ruy M, Pinheiro Luís C, Holdenrieder Stefan, Guimarães João T
机构信息
Department of Clinical Pathology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal;
Department of Laboratory Medicine, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.
出版信息
In Vivo. 2021 Nov-Dec;35(6):3431-3439. doi: 10.21873/invivo.12643.
BACKGROUND/AIM: Lack of interchangeability between prostate-specific antigen (PSA) assays could have a clinical impact. We compared PSA assays from different manufacturers and calibrations.
PATIENTS AND METHODS
A total of 233 men who underwent prostate biopsy (PSA: 2-10 ng/ml; Beckman Coulter Access Hybritech as reference) were enrolled. Total (tPSA) and free PSA (fPSA) were also measured using the Roche cobas and the Abbott Architect methods.
RESULTS
Roche tPSA values were ≈1% higher than Beckman, while Abbott values were ≈5% lower. Roche had the highest diagnostic sensitivity (92%) compared to Beckman Coulter (87%) and Abbott (85%). Roche fPSA was ≈3% lower and Abbott ≈17% higher than that of Beckman. For the percentage of fPSA, Roche had the highest sensitivity (98%).
CONCLUSION
Roche cobas and Beckman Coulter Access Hybritech tPSA were almost interchangeable. While the agreement was acceptable for tPSA, this did not happen with fPSA and greater efforts for harmonization are required.
背景/目的：前列腺特异性抗原（PSA）检测方法之间缺乏互换性可能会产生临床影响。我们比较了不同制造商和校准方法的PSA检测。
患者和方法
共纳入233名接受前列腺活检的男性（PSA：2 - 10 ng/ml；以贝克曼库尔特Access Hybritech检测结果作为参考）。还使用罗氏cobas和雅培Architect方法检测了总PSA（tPSA）和游离PSA（fPSA）。
结果
罗氏tPSA值比贝克曼的高约1%，而雅培的值比贝克曼的低约5%。与贝克曼库尔特（87%）和雅培（85%）相比，罗氏具有最高的诊断敏感性（92%）。罗氏fPSA比贝克曼的低约3%，雅培的比贝克曼的高约17%。对于fPSA百分比，罗氏具有最高的敏感性（98%）。
结论
罗氏cobas和贝克曼库尔特Access Hybritech的tPSA几乎具有互换性。虽然tPSA的一致性可以接受，但fPSA并非如此，需要做出更大努力进行标准化。
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