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Second generation hepatitis C virus assays: performance when testing African sera

J D Callahan1, N T Constantine, P Kataaha

  • 1University of Maryland School of Medicine, Department of Pathology, Baltimore.

Journal of Medical Virology
|September 1, 1993
PubMed
Summary
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Hepatitis C virus (HCV) screening in Uganda revealed significant discordance between assays. Test S1 showed high sensitivity but poor specificity, while S2 had high specificity but low sensitivity, indicating neither test alone is adequate.

Area of Science:

  • Virology
  • Immunology
  • Public Health

Background:

  • Hepatitis C virus (HCV) infection is a global health concern, necessitating accurate diagnostic tools for screening and diagnosis.
  • Uganda, like many regions, faces challenges in controlling HCV transmission, making reliable serological testing crucial for epidemiological surveillance and patient management.

Purpose of the Study:

  • To evaluate the performance of two second-generation HCV antibody screening assays (ELISA S1 and enzyme immunoassay S2) in a Ugandan population.
  • To compare the diagnostic accuracy of these screening assays against supplemental/confirmatory tests (RIBA C1 and INNO-LIA C2).

Main Methods:

  • Sera from 426 Ugandan volunteers at high and low risk for HCV acquisition were tested.
  • Screening was performed using Ortho HCV ELISA (S1) and INNOTEST HCV Ab (S2).

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  • Repeatedly reactive samples underwent confirmatory testing with Ortho RIBA (C1) and INNO-LIA HCV-Ab (C2).

    • Main Results:

    • Assay S1 showed 100% sensitivity but only 49.3% specificity, with 59.4% of samples being repeatedly reactive.
    • Assay S2 demonstrated 98.8% specificity but low sensitivity (31.3%), with only 2.6% of samples repeatedly reactive.
    • Significant discordance was observed between screening and confirmatory assays, and between the two screening assays themselves.

    Conclusions:

    • Neither second-generation screening assay (S1 or S2) alone is adequate for HCV antibody testing in this Ugandan population due to performance limitations.
    • The high false positive rate of S1 and low sensitivity of S2 highlight the need for careful assay selection and interpretation in resource-limited settings.
    • Further investigation into newer generation assays and optimized testing algorithms is warranted for accurate HCV diagnosis in diverse populations.