Clinical Chemistry AACC Online Job Center
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Clinical Chemistry 52: 1592-1598, 2006. First published June 8, 2006; 10.1373/clinchem.2005.064063
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
clinchem.2005.064063v1
52/8/1592    most recent
Right arrow Submit an electronic Letter to
the Editor about this paper
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via ISI Web of Science (1)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Chen, D.
Right arrow Articles by Kaplan, L. A.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Chen, D.
Right arrow Articles by Kaplan, L. A.
Related Collections
Right arrow Other Areas of Clinical Chemistry
(Clinical Chemistry. 2006;52:1592-1598.)
© 2006 American Association for Clinical Chemistry, Inc.

Other Areas of Clinical Chemistry

Performance of a New-Generation Chemiluminescent Assay for Hepatitis B Surface Antigen

Dan Chen1,a and Lawrence A. Kaplan1,2

1 Department of Pathology, New York University, School of Medicine, Clinical Chemistry Laboratory of Bellevue Hospital, New York, NY.

aAddress correspondence to this author at: Department of Pathology, Bellevue Hospital, Room 4S-12, 462 1st Ave., New York, NY 10016. Fax 212-263-8284; e-mail chend09{at}med.nyu.edu.

Background: The usual criteria for analysis of hepatitis B surface antigen (HBsAg) are detection of HBsAg and result confirmation by antibody neutralization. We observed that with the Immulite 2000 HBsAg assay [Diagnostics Product Corporation (DPC)] a relatively high percentage of weakly reactive (WR) samples did not pass the neutralization step.

Methods: For each of 3 lots of Immulite 2000 HBsAg reagent (DPC), we collected and analyzed HBsAg data from ~3000 to 4000 patient blood samples and compared these data with HBsAg data from 3393 samples tested with the Abbott Auszyme assay. For 127 samples with initially WR detection signals (relative signal/cutoff index of 1.00–2.5) on the Immulite 2000 HBsAg assay, we then measured hepatitis B (HB) viral load and/or other HB serologic markers.

Results: The Immulite 2000 HBsAg assay produced more initially reactive results than the Abbott Auszyme method. Many of these reactive samples, however, were WR and did not meet the confirmation criteria in the neutralization test. Moreover, DNA PCR testing indicated that 22 of the 38 WR samples (58%) that did meet the confirmation criteria had no detectable HB viral DNA.

Conclusions: Immulite 2000 HBsAg assay results include a unique group of WR samples that are associated with both false-positive and false-negative results, regardless of neutralization status, and require careful interpretation. WR HBsAg samples should be reported as confirmed HBsAg reactive only if the samples not only meet the neutralization criteria but also are positive for other HB serologic markers such as anti-HB core total and anti-HB core IgM.




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
D. R. Dufour
Hepatitis B Surface Antigen (HBsAg) Assays--Are They Good Enough for Their Current Uses?
Clin. Chem., August 1, 2006; 52(8): 1457 - 1459.
[Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2006 by the American Association for Clinical Chemistry.