Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria.
Clin Chim Acta. 2011 Nov 20;412(23-24):2277-83. doi: 10.1016/j.cca.2011.08.016. Epub 2011 Aug 24.
The biomarkers proguanylin and prouroguanylin are members of the natriuretic peptide family. The aim of this study was to evaluate two commercially available assays for proguanylin and prouroguanylin and to further characterize both analytes in terms of important clinical features.
We evaluated precision and linearity of the BioVendor human proguanylin and prouroguanylin ELISAs. In order to characterize both analytes, we tested in vitro analyte stabilities at -80 °C, and determined biological variability and reference values for proguanylin and prouroguanylin.
Within-run and total coefficients of variation were <10% for the BioVendor proguanylin and prouroguanylin assays. Both methods were linear across the tested measurement ranges. The analytes proguanylin and prouroguanylin were stable for at least 2 months at -80 °C. With respect to biological variability, the reference change values (RCV) were 27% and 59% for proguanylin and prouroguanylin, respectively. For proguanylin, age-independent reference values were 4.0-13.4 ng/mL in males and 4.6-16.3 ng/mL in females. For prouroguanylin, age- and sex-independent reference values were 2.1-11.2 ng/mL.
The BioVendor human proguanylin ELISA and the BioVendor human prouroguanylin ELISA meet the needs of quality specifications of laboratory medicine. The results of the characterization of both analytes provide essential information for further clinical studies.
脯氨酸血管加压素原和尿鸟苷酸原是利钠肽家族的成员。本研究的目的是评估两种商业上可获得的脯氨酸血管加压素原和尿鸟苷酸原检测试剂盒，并进一步从重要的临床特征方面对这两种分析物进行特征描述。
我们评估了 BioVendor 人脯氨酸血管加压素原和尿鸟苷酸原 ELISA 的精密度和线性。为了对这两种分析物进行特征描述，我们测试了在-80°C 下的体外分析物稳定性，并确定了脯氨酸血管加压素原和尿鸟苷酸原的生物学变异性和参考值。
BioVendor 人脯氨酸血管加压素原和尿鸟苷酸原 ELISA 的批内和总变异系数均<10%。两种方法在测试的测量范围内均呈线性。分析物脯氨酸血管加压素原和尿鸟苷酸原在-80°C 下至少稳定 2 个月。关于生物学变异性，脯氨酸血管加压素原和尿鸟苷酸原的参考变化值（RCV）分别为 27%和 59%。对于脯氨酸血管加压素原，男性的年龄独立参考值为 4.0-13.4ng/mL，女性为 4.6-16.3ng/mL。对于尿鸟苷酸原，年龄和性别独立的参考值为 2.1-11.2ng/mL。
BioVendor 人脯氨酸血管加压素原 ELISA 和 BioVendor 人尿鸟苷酸原 ELISA 满足实验室医学质量规范的需求。对这两种分析物的特征描述结果为进一步的临床研究提供了重要信息。
