Background/Case Studies: IH-AbID is the integrated antibody identification software for IH-Com and is FDA cleared. These data are the result of a performance study comparing the automated interpretation provided by IH-AbID to the standard practice using manually completed worksheets.
Study
Design/Methods: IH-AbID was evaluated at two sites involving three users with various levels of expertise in blood banking. Each site provided between fifteen to twenty leftover samples containing one or more clinically significant antibodies directed against antigens from several blood group systems (Rh, Kidd, Duffy, Kell, MNS). In addition, eight well-characterized samples were provided by Bio-Rad. Samples were tested using IH-Cards AHG Anti-IgG and Red Blood Cell panels on the IH-500 and interpreted by IH-AbID. Results from the IH-500 were also provided to a reference operator for blinded manual interpretation. The agreement was determined by the number of identical conclusions between the automated and manual interpretations.
Results/Findings: The performance evaluation showed 92% strict agreement (69/75) between the automated and the manual interpretation. Out of the 48 samples tested, 34 had a single red cell antibody and 14 samples presented with more than one specificity. For 3 samples with multiple antibodies, IH-AbID correctly identified the specificities with 2 anti-M and 1 anti-K categorized as “possible” whilst these 3 antibodies could not be ruled out due to limited availability of reagent red cells for manual testing. In 2 samples containing several antibodies, the software reported the correct specificities and listed an additional anti-N and an anti-K as “possible” which were eventually reported as “not ruled out” in manual after a second review. For another sample, specificities were correctly reported by IH-AbID along with an anti-E reported as “possible” which was ruled out in manual testing using a single dose cell in the presence of anti-D. There was one discrepant result for a specificity within a mixture of antibodies. The sample was tested three times and correctly interpreted twice (anti-D,-C) but on the third occasion, IH-AbID interpretation was anti-C,-E. This was not due to the software but the difference in the result with one red blood cell. Conclusions: Performance evaluation of IH-AbID compared to manual interpretation showed excellent concordance and there was no discrepant result attributable to the software. The IH-AbID software is a user-friendly tool developed to systemize the antibody identification process and has greatest utility on off-shifts where typically laboratory personnel are less experienced in antibody identification.
Importance of research: Antibody identification is carried out to assign a specificity and evaluate its clinical significance in a transfusion or antenatal context. It is a challenging task as it requires in-depth knowledge of antibody behavior, rules to exclude or identify the specificity as well as zygosity and dosage phenomenon. The IH-AbID software is a user-friendly tool developed to systemize this process and facilitate routine work to laboratory staff.
