4. Verification of chemiluminescent immunoassay to measure renin activity, direct renin and aldosterone concentrations
Main Article Content
Abstract
Plasma renin activity (PRA), plasma rennin concentration (PRC), plasma aldosterone concentration (PAC) and Aldosterone/Renin ratio are used to diagnose and monitor diseases related to the activity of the renin - angiotensin - aldosterone system. The chemicals and quality control materials of Snibe were used to conduct the assessment of precision and trueness on Maglumi 800 analyzer according to CLSI’s EP15-A3 guidelines. The within-run CV and within-laboratory CV of the direct renin assay at QC level 1 were 4.90% and 6.57%, respectively. The within-run CV was less than the within-run CV provided by the manufacturer, the within-laboratory CV was greater than the manufacturer's claims but did not exceed the upper verification limit (UVL). At QC level 2 of this assay, the within-run CV and within-laboratory CV were 3.02% and 3.02%, respectively. These values are less than CV of the manufacturer. The within-run CV of the renin activity assay (2.97%) was greater than the within-run CV provided by the manufacturer (2.46%) but did not exceed the UVL (3.08%) and the within-laboratory CV (2.73%) smaller than the CV announced by the manufacturer (3.38%). The within-run CV and within-laboratory CV of aldosterone assay were 2.83% and 2.95%, respectively, which is smaller than the CV announced by the manufacturer. In direct rennin assay, the observed mean value of the QC level 1 is within the verification interval, the observed mean of the QC level 2 is out of the verification interval, but the bias is less than the optimal standard of bias based on the biological variability. The observed mean of the renin activity assay was within the verification interval. The observed mean of the aldosterone assay is out of the verification interval, but the bias is less than the optimal standard of bias based on the biological variability. In conclusion, the precision and trueness of direct rennin assay, rennin activity assay and aldosterone assay were verified, and the tests can be used for routine practice.
Article Details
Keywords
Plasma renin activity, plasma rennin concentration, plasma aldosterone concentration, method verification, EP15-A3
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