Abstract: Objective  To investigate the application of 2 quality standards in clinical chemical analysis performance evaluation.  Methods  The internal quality control imprecision and external quality control average deviation of our laboratory (HITACHI analysis system) were selected. The imprecision and inaccuracy of complete test system (Modular PPI analysis system) approved by the Food and Drug Administration (FDA) were selected. The allowable total error (TEa) according to the Clinical Laboratory Improvement Amendment (CLIA′88) were made by the biological variation (BV). Making use of Westgard performance evaluation decision graph, each detection system analysis performance meeting the prescribed quality requirements or not was analyzed. The analysis performance detection rate and applicability of Modular PPI analysis system with 2 quality standards were analyzed and evaluated. Results  In 23 items，with CLIA′88 allow quality standards and requirements, the HITACHI system′s urea (Ur) and chlorine (Cl^-) determination methods can not satisfy the quality requirements， total protein (TP)， creatine kinase (CK) and uric acid (UA) belonged to the critical levels，total bilirubin (TBil)，alkaline phosphatase(ALP), total cholesterol(TC)，natrium (Na⁺) and magnesium (Mg) analysis performances were good，and the other 11 item analysis system performances were excellent. In the Modular PPI system, project analysis performance can be accepted. Meanwhile, the excellent rate，good rate，edge rate and discrepancy rate were 75%， 15%，10% and 0%，and for the BV "low limit"，"appropriate" and "ideal" quality standards, its discrepancy rates were 21%, 48% and 65%. Conclusions  Westgard performance evaluation decision graph for evaluating the performance of biochemical detection system is accurate， simple and suitable for clinical laboratory application， and CLIA′88 quality requirement is more suitable than the current laboratory quality requirement. BV quality requirements are suitable for a part of excellent performance items.

Key words: Detection system, Clinical laboratory, Quality control, Detection system, Clinical laboratory, Quality control