Validity of the rapid strip assay test for detecting HBsAg in patients admitted to hospital in Uganda

E. Seremba, P. Ocama, C. K. Opio, M. Kagimu, H. J. Yuan, N. Attar, D. L. Thomas, W. M. Lee

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21 Scopus citations

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 HBsAg-negative 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 all HBVDNA positive sera. A more complex testing protocol than RSA alone will be needed in Africa to improve patient care.

Original languageEnglish (US)
Pages (from-to)1334-1340
Number of pages7
JournalJournal of Medical Virology
Volume82
Issue number8
DOIs
StatePublished - Aug 1 2010

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Keywords

  • Enzyme immunoassay
  • HBsAg
  • Nucleic acid testing
  • Rapid strip assay

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

Seremba, E., Ocama, P., Opio, C. K., Kagimu, M., Yuan, H. J., Attar, N., Thomas, D. L., & 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. https://doi.org/10.1002/jmv.21813