Fujirebio Diagnostics Inc, Malvern, PA, USA.
Clin Chem Lab Med. 2013 Apr;51(4):873-80. doi: 10.1515/cclm-2012-0660.
Quality control materials with minimal inter-assay differences and clinically relevant proportions of different molecular forms of the analyte are needed to optimize intra- and inter-laboratory accuracy and precision.
We assessed if clinically relevant total prostate-specific antigen (tPSA) levels were present in seven commercially available Multi Constituent Tumor Marker Controls (MC-TMC). Further, we determined the concentration of free PSA (fPSA) and calculated the percentage of free PSA (%fPSA) in all materials. Finally, we determined variability of TMC materials across several commonly used PSA platforms.
All MC-TMC materials contained at least one concentration of tPSA in normal and pathologic range. Control materials varied in the amount of fPSA and %fPSA, with most controls consisting of fPSA only and only one MC-TMC containing medically relevant levels of around 35% fPSA. Only a minority of MC-TMC materials showed minimal variability across four PSA methods while the majority of PSA controls showed wide inter-method differences.
Use of many commercially available controls for PSA could lead to biased PSA measurements because they contain medically irrelevant proportions of fPSA and show significant variation among different PSA assay platforms.
需要具有最小分析内差异和临床相关比例的分析物不同分子形式的质量控制材料，以优化实验室内部和实验室之间的准确性和精密度。
我们评估了七种市售的多成分肿瘤标志物质控品（MC-TMC）中是否存在临床相关的总前列腺特异性抗原（tPSA）水平。此外，我们测定了所有材料中的游离前列腺特异性抗原（fPSA）浓度，并计算了游离前列腺特异性抗原的百分比（%fPSA）。最后，我们确定了 TMC 材料在几个常用 PSA 平台上的变异性。
所有 MC-TMC 材料均含有正常和病理范围内的至少一个 tPSA 浓度。对照材料在 fPSA 和%fPSA 的量上有所不同，大多数对照品仅含有 fPSA，只有一种 MC-TMC 含有约 35%的 fPSA，这具有医学意义。只有少数 MC-TMC 材料在四个 PSA 方法之间显示出最小的变异性，而大多数 PSA 对照品在不同的 PSA 检测平台之间显示出广泛的方法间差异。
由于许多市售的 PSA 对照品含有与医学无关的 fPSA 比例，并且在不同的 PSA 检测平台之间显示出显著的差异，因此使用许多市售的对照品可能会导致 PSA 测量结果出现偏差。
