Antibody Titers in Transfusion Medicine: A Critical Reevaluation of Testing Accuracy, Reliability, and Clinical Use.

TitleAntibody Titers in Transfusion Medicine: A Critical Reevaluation of Testing Accuracy, Reliability, and Clinical Use.
Publication TypeJournal Article
Year of Publication2023
AuthorsKarafin MS, DeSimone RA, Dvorak J, Metcalf RA, Pagano MB, Park YA, Schwartz J, Souers RJ, Szczepiorkowski ZM, Uhl L, Ramsey G
JournalArch Pathol Lab Med
Date Published2023 Dec 01
KeywordsAntibodies, Humans, Laboratories, Quality Control, Reproducibility of Results, Transfusion Medicine

CONTEXT.—: Substantial variability between different antibody titration methods has been identified since the development and introduction of the uniform procedure in 2008.

OBJECTIVE.—: To determine whether more recent methods or techniques decrease interlaboratory and intralaboratory variation measured using proficiency testing.

DESIGN.—: Proficiency test data for antibody titration between 2014 and 2018 were obtained from the College of American Pathologists. Interlaboratory and intralaboratory variations were compared by analyzing the distribution of titer results by method and phase, comparing the results against the supplier's quality control titer, and by evaluating the distribution of paired titer results when each laboratory received a sample with the same titer twice.

RESULTS.—: A total of 1337 laboratories participated in the antibody titer proficiency test during the study period. Only 54.1% (5874 of 10 852) of anti-D and 63.4% (3603 of 5680) of anti-A reported responses were within 1 titer of the supplier's intended result. Review of the agreement between laboratories of the same methodology found that 78.4% (3139 of 4004) for anti-A and 89.0% (9655 of 10 852) of laboratory responses for anti-D fell within 1 titer of the mode response. When provided with 2 consecutive samples of the same titer (anti-D titer: 16), 85% (367 of 434) of laboratories using the uniform procedure and 80% (458 of 576) using the other method reported a titer difference of 1 or less.

CONCLUSIONS.—: Despite advances, interlaboratory and intralaboratory variance for this assay remains high in comparison with the strong reliance on titer results in clinical practice. There needs to be a reevaluation of the role of this test in clinical decision-making.

Alternate JournalArch Pathol Lab Med
PubMed ID36730468
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Robert DeSimone, M.D.

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