Evaluation of Access Anti-HCV Assay on DxI 9000
Immunoassay Analyzer* for Detection of HCV Antibody



Background: Hepatitis C virus (HCV) has a global prevalence of almost 60 million cases, and the numbers are on the rise.1 Timely and accurate HCV testing is important for providing information and initiating treatment as well as for reducing HCV infections.2 Recently, we developed a fully automated, low sample volume (3 µL) anti-HCV assay for use on the new DxI 9000 Immunoassay analyzer. This evaluation assessed within-laboratory imprecision, reproducibility, and analytical specificity, as well as agreement with the ARCHITECT Anti-HCV assay.

Methods: 20-day imprecision and five-day reproducibility studies were performed based on CLSI EP05-A3. Analytical specificity was evaluated using CLSI EP07 for cross-reactivity and interference studies. Each potential cross-reactant was represented by ten specimens and included specimens from viral infections, autoimmune diseases, non-viral liver diseases, post-vaccination patients, and pregnant women. For interference studies, known concentrations of potential interferents were added to patient samples and compared with controls. A concordance study was performed between Beckman Coulter’s Access Anti-HCV and Abbott’s ARCHITECT Anti-HCV assays using samples from hospitalized patients and presumed HCV antibody-positive patients. Supplementary testing using immunoblot and/or HCV PCR was also performed, as necessary, to provide additional sample status information.

Results: The Access Anti-HCV assay met stated claims for within-laboratory imprecision, demonstrating combined and within-site reproducibility below 0.100 S/CO SD for negative samples and below 10.0% CV for positive samples. A total of 360 samples were tested for potential cross-reactivity with 100.0% specificity obtained. Samples containing up to 1000 mg/dL hemoglobin, 15 g/dL total protein, 43 mg/dL bilirubin, 3510 ng/mL biotin, or 37 mmol/L intralipid showed no interference. Concordance analysis with the Abbott ARCHITECT Anti-HCV assay showed a negative percent agreement of 98.9% and a positive percent agreement of 98.7%. Six PCR-positive hospitalized patient samples that were detected by the Access Anti-HCV assay were not detected by the Abbott ARCHITECT Anti-HCV assay, suggesting potentially better sensitivity with these 6 samples compared with the Abbott ARCHITECT Anti-HCV assay.

Conclusion: The newly developed Access Anti-HCV assay for use on the DxI 9000 Access Immunoassay Analyzer demonstrated excellent analytical performance and strong agreement with currently marketed anti-HCV assays.

The study found:

  • No interference with hemoglobin, protein, bilirubin, biotin or intralipid
  • Excellent positive and negative percent agreement with potentially better sensitivity than currently marketed anti-HCV assays
  • High analytical specificity and reproducibility

At a Glance

100 %
Specificity obtained
CV for positive samples
Within-site reproducibility


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1. World Health Organization. Hepatitis C. Hepatitis C. June 24, 2022. Accessed July 5, 2023. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

2. Stockman LJ, Guilfoye SM, Benoit AL, Vergeront JM, Davis JP, Centers for Disease Control and Prevention (CDC). Rapid hepatitis C testing among persons at increased risk for infection--Wisconsin, 2012-2013. MMWR Morb Mortal Wkly Rep. 2014;63(14):309-311.

*Full Name: DxI 9000 Access Immunoassay Analyzer