Validity of the Rapid Strip Assay Test for Detecting HBsAg in Patients Admitted to Hospital in Uganda
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Date
2010
Journal Title
Journal ISSN
Volume Title
Publisher
Journal of medical virology
Abstract
Commercially available rapid strip assays (RSAs)
for hepatitis B surface antigen (HBsAg) are used
for most routine clinical testing in sub-Saharan
Africa. This study evaluated the validity of RSA
and a more sophisticated enzyme immunoassay
(EIA) with confirmation by nucleic acid testing
(NAT) in hospitalized patients in Uganda. Sera
from 380 consecutive patients collected and
tested for HBsAg and anti-HIV in Kampala,
Uganda by RSA were sent frozen to Dallas for
EIA including HBsAg, total anti-hepatitis B core,
hepatitis B e antigen, and anti-HIV. NAT was
performed on all HBsAg-positives and on a
random sample of 102 patients that were HBsAgnegative
by both assays. Overall, 31 (8%) were
HBsAg positive by RSA while 50 (13%) were
HBsAg-positive by EIA; 26 were concordant
between the two assays. Of 55 HBsAg-positive
patients, nearly all showed detectable serum
hepatitis B virus (HBV) DNA by bDNA (46) or PCR
(4) assay. The 26 patients who were HBsAg
positive by both EIA and RSA had significantly
higher median serum HBV DNA levels than
the 24 patients who were HBsAg positive by
EIA alone. An additional 12/102 (12%) HBsAg
negative patients had very low serum HBV DNA
levels by NAT. Several differences in expected
results of serologic testing were observed in this
large series of African patients. RSA HBsAg testing
is less sensitive than EIA; even EIA failed to
detect allHBVDNApositive sera.Amorecomplex
testing protocol than RSA alone will be needed in
Africa to improve patient care. J. Med. Virol.
82:1334–1340, 2010. 2010 Wiley-Liss, Inc.
Description
Keywords
Rapid strip assay, Enzyme immunoassay, Nucleic acid testing, HBsAg
Citation
Seremba, E., Ocama, P., Opio, C. K., Kagimu, M., Yuan, H. J., Attar, N., ... & Lee, W. M. (2010). Validity of the rapid strip assay test for detecting HBsAg in patients admitted to hospital in Uganda. Journal of medical virology, 82(8), 1334-1340. DOI 10.1002/jmv.21813