Performance verification of RAAS by AutoLumo A2000chemiluminescence detector / 医疗卫生装备

ABSTRACT

Objective To verify the performance of AutoLumo A2000 chemiluminescence detector in the detection of renin, angiotensin and aldosterone. Methods A set of laboratory verification scheme was proposed with chemiluminescence detector with references to EP15-A2, EP6-A2, EP7-A2 and C28-A2 from Clinical and Laboratory Standards Institute (CLSI), which detected the precision, limit of quantitation, analytical measurement range, interference testing and reference intervals. Results The coefficients of variation (CV) for repeatability precision were between 1.8%and 4.2%, and those for intermediate precision were between 2.4%and 5.4%. The limit of quantitations of renin, angiotensin and aldosterone were 2.7 pg/ml, 10.0 pg/ml, and 9.5 pg/ml, respectively. Analytical measurement ranges were accordance with the manufacturer. The results were interfered by hemolytic, jaundice or cheliform samples. The reference intervals of erect position were verified. Conclusion AutoLumo A2000 chemiluminescence detector behaves well in the precision, limit of quantitation, analytical measurement range and reference intervals. The main performances of the analyzer meet the standards of the quality requirements.