Performance evaluation of the ADVIA Centaur anti-HBe and HBeAg assays.
BACKGROUND
Detection of HBeAg and anti-HBe is valuable for the evaluation and therapeutic management of hepatitis B infection.


OBJECTIVE
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.


METHODS
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.
van Helden
Josef
J
Gemeinschaftspraxis fuer Laboratoriumsmedizin, Mikrobiologie und Humangenetik, Dr. Stein & Kollegen, Wallstrasse 10, D41061 Moenchengladbach, Germany. jvhelden@labor-stein.de
Cornely
Carl
C
Dati
Francesco
F
Levy
H Roma
HR
Bal
Tricia
T
Seeger
Mary
M
Wright
Theodore
T
Baker
Lawrence
L
D001331:Automation; D006509:Hepatitis B / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D006510:Hepatitis B Antibodies / Q000097:blood*; D006513:Hepatitis B e Antigens / Q000097:blood* / Q000276:immunology; D006515:Hepatitis B virus / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D006510:Hepatitis B Antibodies; D006513:Hepatitis B e Antigens; D011933:Reagent Kits, Diagnostic