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Performance evaluation of the ADVIA Centaur anti-HBe and HBeAg assays
Josef van Helden1, Carl Cornely, Francesco Dati
1Gemeinschaftspraxis fuer Laboratoriumsmedizin, Mikrobiologie und Humangenetik, Dr. Stein & Kollegen, Wallstrasse 10, D41061 Moenchengladbach, Germany. jvhelden@labor-stein.de
Background:
Detection of HBeAg and anti-HBe is valuable for the evaluation and therapeutic management of hepatitis B infection.
Objectives:
To determine the clinical performance of the newly CE-approved(a) HBeAg and anti-HBe assays on the fully automated, random access ADVIA Centaur immunoassay system.
Study Design:
Patient samples collected at two sites were used to compare the ADVIA Centaur assays to Abbott AxSYM assays. Consensus of discordant results was reached using Roche Elecsys assays. Additionally, two well-characterized seroconversion panels were evaluated.
Results:
The ADVIA Centaur HBeAg assay sensitivity was 100% and specificity was 99.5%. The ADVIA Centaur anti-HBe assay sensitivity was 100% and the resolved specificity was 98.2%. Fewer samples required retesting with the ADVIA Centaur assays than with the AxSYM. In two well-characterized seroconversion panels, the ADVIA Centaur anti-HBe assay detected anti-HBe 20-25 days earlier than the AxSYM assay; the ADVIA Centaur and AxSYM HBeAg assays detected HBe reactivity on the same day.
Conclusions:
The ADVIA Centaur HBeAg and anti-HBe assays demonstrated good sensitivity and specificity, and thus are suitable for clinical use. Their novel algorithms require reduced retesting, suggesting these assays may be more cost effective.
