Performance of ARCHITECT HCV core antigen test with specimens from US plasma donors and injecting drug users

https://doi.org/10.1016/j.jcv.2015.02.015Get rights and content

Highlights

  • HCV core antigen is a marker of current HCV infection.

  • The Abbott ARCHITECT HCV core antigen assay shows excellent concordance with HCV RNA titers.

  • The HCV core antigen test has excellent performance characteristics which warrant its inclusion among the markers for diagnosing current HCV infection in the United States.

Abstract

Background

Hepatitis C virus (HCV) core antigen is a serological marker of current HCV infection.

Objectives

The aim of this study was mainly to evaluate the performance characteristics of the ARCITECT HCV core antigen assay with specimens from US plasma donors and injecting drug users.

Study design

A total of 551 serum and plasma samples with known anti-HCV and HCV RNA status were tested for HCV core antigen using the Abbott ARCHITECT HCV core antigen test.

Results

HCV core antigen was detectable in 100% of US plasma donor samples collected during the pre-seroconversion phase of infection (anti-HCV negative/HCV RNA positive). Overall sensitivity of the HCV core antigen assay was 88.9–94.3% in samples collected after seroconversion. The correlation between HCV core antigen and HCV RNA titers was 0.959.

Conclusions

HCV core antigen testing may be reliably used to identify current HCV infection.

Section snippets

Background

The primary serologic test for identification of current or past hepatitis C virus (HCV) infection has been the detection of antibody to HCV (anti-HCV). Updated guidelines published by the United States Centers for Disease Control and Prevention (CDC) [1] recommend that serum or plasma found reactive for anti-HCV be followed by nucleic acid testing (NAT) for HCV RNA; a positive HCV RNA result indicates current HCV infection. A viremic person, who is considered currently HCV-infected, should

Objectives

In this study, we evaluated the performance characteristics of the Abbott HCV core antigen assay using evaluation panels that included samples collected from US plasma donors and injecting drug users.

Sample evaluation panels

A total of 551 serum samples previously tested for anti-HCV and HCV RNA formed the two evaluation panels. All samples were stored at −70°C until use. Panel I consisted of 175 plasma samples from a US plasma donor center that were rejected due to anti-HCV-reactivity and/or HCV-RNA-positivity. Panel II consisted of 376 serum samples from a cohort of young injection drug users from California [23] that were positive for anti-HCV and/or HCV RNA. Samples from these two panels were used to evaluate

Results

Panel I: Of 175 plasma donor samples, 73 (41.7%) were anti-HCV-nonreactive/HCV-RNA-positive, 72 (41.1%) were anti-HCV reactive/HCV-RNA-positive, and 30 (17.1%) were anti-HCV-reactive/HCV-RNA-negative (Table 1). Of the anti-HCV and HCV-RNA-positive samples, HCV core antigen was detected in 64 (88.9%) and in all 73 (100%) anti-HCV-nonreactive/HCV-RNA-positive samples. Overall, of the 145 HCV-RNA-positive samples [HCV RNA titers ranged from 2.91 log10 IU/ml to 7.74 log10 IU/mL (mean, 5.69 log10

Discussion

Anti-HCV is the only serological marker for which assays have been approved for clinical use by FDA in the United States. These assays can detect anti-HCV approximately seven weeks after exposure to HCV. However, anti-HCV antibodies are present in an infected person in acute, chronic and resolved phases of infection and therefore cannot distinguish between past and current HCV infection. HCV antigens are detectable in blood of infected individuals within the first two weeks after exposure and

Funding

This work was supported by the Centers for Disease Control and Prevention. Reagents for HCV core antigen testing were supplied by Abbott Diagnostics.

Competing interests

G.J. Dawson and K. Cheng are employed by Abbott Laboratories. All other authors have no commercial or other association that poses a conflict of interest.

Ethical approval

None required.

Acknowledgments

We are grateful to Chris Snead for the use of the Architect i2000SR, Lilia Ganova-Raeva and Tracy Greene-Montfort for genotyping the specimens.

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