Performance Evaluation of Mindray SAL 8000: a New Integrated Clinical Chemistry and Immunoassay Analyzer System.

Jie Yang; Maocheng Li; Hanyun Zhang; Peng Zhang; Lifei Zhao; Deyu Zeng; Ling Li; Huihui Fan; Fangyin Zeng

Background: The Mindray SAL 8000 is an integrated serum analyzer for photometric, electrochemical, and immunological assays. The technical, analytical, and workflow performance of the system were evaluated in this study. Methods: The technical evaluation was performed using protocols adopted from the guidelines of the China Food and Drug Administration (CFDA). The precision, linearity, interference, and method comparison were carried out according to the Clinical and Laboratory Standards Institute (CLSI) protocols. The verification of carryover and turnaround time were conducted using specimens containing different analytes. Results: The technical performance was acceptable for all evaluated aspects. The repeatability and within-laboratory coefficients of variation (CVs) ranged between 0.22% and 4.23% for routine chemistry and between 1.05% and 6.89% for immunochemistry, respectively. All evaluated analytes exhibited linearity over the ranges claimed by the manufacturer. Significant interferences were observed during low concentration TBIL and P measurements due to the presence of lipemia. Method comparisons showed good agreement with the comparison systems and with the correlation coefficients ≥ 0.988 except for anti-HBs (r = 0.812). No significant intra-module and intermodule carryovers were detected. For all the 1,220 samples, 25%, 54%, 63%, 79%, 91%, and 100% samples completed analysis in 16.3 minutes, 30 minutes, 60 minutes, 120 minutes, 180 minutes, and 320 minutes, respectively. Conclusions: The Mindray SAL 8000 integrated system achieved optimal technical performance and met most of the criteria regarding analytical performance. The workflow study of the system met the turnaround time (TAT) requirements of laboratories. Therefore, it is a good candidate to be used in medium and large-sized laboratories.

CHINA; TURNAROUND time; WORKFLOW; IMMUNOASSAY; CLINICAL chemistry; PATHOLOGICAL laboratories; IMMUNOCHEMISTRY

Clinical Laboratory, 2019, Vol 65, Issue 7, p1211

1433-6510

Academic Journal

10.7754/Clin.Lab.2019.181228