TRA-03 : Comparison of Accuracy between the Fully Automated Instrument and Manual Methods
Jinmi Park, Moonjin Kim, Hyundo Jeong, Saeam Song · 2017
Background: The automation system has been developed and is now used widely. There are some reasons why we have to use this system for the highly reliable test: to decrease the risks of human error linked to each step of the tests performed; to guarantee a reliable traceability of all the elements having contributed to the test process; to manage all the alarms of dysfunction of the system. In this study, We compared the results of ABO-RhD typing and unexpected antibody screening using the manual method and with the IH-500 (Bio-Rad, Switzerland) to use it this Laboratory. Methods: In total, 200 blood samples for ABO-RhD Typing and 100 blood samples for unexpected antibody screening were tested with the IH-500; all samples were run in parallel with the reference manual method according to the laboratory protocol. We evaluated the accuracy between IH-500 and manual methods in terms of concordance, carryover, and sensitivity test for ABO-RhD typing and unexpected antibody screening. Results: Of 200 samples tested for ABO-Rh typing, 6 samples could not be interpreted by the IH-500,because of bone marrow transplantation patient’s samples. The error code “ABO Discrepancy“ displayed on the instrument screen. Therefore, we could be able to recheck in order to confirm error samples. All the results for ABO-Rh typing were concordant for 100 percent of the remaining samples. There was 100 percent concordance of results for unexpected antibody screening. Additionally, of 17 exact positive result were observed from both IH-500 and Manual methods. There was 100 percent concordance and sensitivity of both tests. Conclusion: The fully automated instrument IH-500 showed the good performance and concordance of results with manual methods. The IH-500 automates routine blood bank tests with accuracy comparable to that of hospital reference manual methods. However, we have to recheck when the instrument displayed the error code. Except in this case, We can believe the results that send me from the instrument.