PB1136 - Preliminary Establishment of intelligent pre-analytical quality control system on total laboratory automation platform for coagulation assays

Background: Fully automated platform are increasingly being used in high throughout laboratories which improve their productivity. But there are still some unintelligent defects, especially the intelligent pre-analytical quality control system has not been established.

Aims: To establish HIL alert indices and volume check allowable ranges of CS5100 and CN6000 automated coagulation analyzers.

Methods: The Specimen analysis process and Lis were evaluated and optimized. 21 and 206 samples with different interference concentrations were used to evaluate repeatability and consistency of HIL indices between two systems. 425 specimens were collected to evaluate the concentration distribution of interfering substances at different HIL indices, and 378 samples were used to evaluate the consistency between manual and instrumental HIL index judgments. 6 coagulation screening tests of normal and artificial HIL samples were analyzed parallelly, and the HIL index were recorded, and the HIL alert index for different intervals of each test were determined. 10 artificial samples were prepared to establish the allowable range for volume check, and 2933 samples were used to validate the range.

Results: Specimens can be tested in registration order but with high priority if they were from emergency. LIS enables to send pre-analytical TAT timeout and Hct >55% alerts. The repeatability of the HIL index was good, and the consistency between systems is good (K=0.969- 0.991, P = 0.000). The consistency between instrument and manual judgment in evaluating hemolytic samples was average (K=0.421-0.702, P< 0.001), which was poor (K=0.023-0.267, P=0.258 or P< 0.001) on jaundice samples but was good (K= 0.559-0.838, P< 0.001) for chyle samples. The HIL alert index varies between different intervals of each test(see table1). The volume check allowable ranges were 41.3～73.3mm.

Conclusion(s): We preliminarily determined the HIL alert indices and volume check allowable range for coagulation screening tests, which providing a basis for intelligent management of pre-analytical quality control.