Abstract：Objective To compare the accuracy and repeatability of the cross-matching tests between the domestic and imported
instruments, investigate the new instruments application process, and explore the effect of bidirectional transmission in improving
the accuracy of results reporting. Methods Fresh anticoagulated whole blood was used to perform cross-repeated tests on the two
instruments called WADiana and AISEN120. By comparing the reporting of results and agglutination intensity of the two instruments,
the accuracy of test results of AISEN120 and the consistency with WADiana were evaluated. Through the hospital LIS and HIS
systems, data interface software technology was used to carry out bidirectional transmission of medical advices and laboratory
results. Results The two instruments performed 300 cases of blood group identification and 100 cases of cross-matching experiments
respectively. After adjusting the photographic interpretation system, the sample adding system, and pre-test quality control of
consumables, the coincidence rates of the results of the two instruments’ blood group identification and cross-matching tests were
98% and 100% respectively. The coincidence rate of blood group identification with the tube method was 99%. Conclusion The
testing capacity of AISEN120 are consistent with the imported instrument, all results can be transferred to proprietary software for
storage, and the introduction of bidirectional transfer function can reduce human errors. This study provides valuable basic data and
application process model reference for other medical institutions to choose relevant domestic instruments.
何欣，刘思琪，陈麟凤. 一种国产全自动输血相容性检测仪器的性能验证分析研究[J]. 中国医疗设备, 2021, 36(5): 47-50.
HE Xin, LIU Siqi, CHEN Linfeng. Performance Verification and Analysis of a Domestic Automatic Blood
Transfusion Compatibility Testing Instruments. China Medical Devices, 2021, 36(5): 47-50.
