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Published on: December 12, 2011
Performance evaluation of the access anti-HBc IgM Assay on the DxI 9000 access immunoassay analyzer
Catherine Coignard1, Claire Vincent2, Veronique Lemée3
1Infectiology, Specialized CoreLab Department, Eurofins Biomnis, Ivry-Sur-Seine, France.
Insights
The Access anti-HBc IgM assay shows excellent diagnostic performance for detecting Hepatitis B virus infection. This new assay offers earlier detection during seroconversion compared to existing methods.
Area of Science:
- Clinical Chemistry
- Hepatology
- Infectious Diseases
Background:
- Hepatitis B virus (HBV) infection remains a significant global health concern.
- Accurate and timely diagnosis of acute HBV infection is crucial for effective patient management.
- Anti-HBc IgM is a key serological marker for acute and recent HBV infection.
Purpose of the Study:
- To evaluate the diagnostic and analytical performance of the Access anti-HBc IgM assay.
- To assess the assay's reliability on the DxI 9000 Access Immunoassay Analyzer.
- To compare the Access assay's performance against a comparator assay.
Main Methods:
- Prospective and retrospective collection of patient samples.
- Testing samples with the Access anti-HBc IgM assay and a comparator assay.
- Utilizing a second comparator for discrepant sample resolution.
- Evaluation of specificity, sensitivity, and reproducibility.
Main Results:
- Excellent specificity observed across different sample groups (blood donors, hospitalized patients, HBV-infected patients).
- 100% sensitivity for detecting anti-HBc IgM in acute/recent and chronic HBV infected patients.
- Earlier detection of seroconversion by an average of 3.2 days compared to the comparator assay.
- High reproducibility with low coefficient of variance (CV) and standard deviation (SD).
Conclusions:
- The Access anti-HBc IgM assay demonstrates excellent diagnostic and analytical performance.
- The assay is comparable to other current CE-marked anti-HBc IgM assays.
- The Access assay offers a valuable tool for the diagnosis of Hepatitis B virus infection, particularly in early stages.
Abstract:
This study evaluated the diagnostic and analytical performances of the Access anti-HBc IgM assay (Access assay) for use on the DxI 9000 Access Immunoassay Analyzer. Prospectively and retrospectively collected samples were tested with Access and a comparator assay with use of a second comparator for discrepant resolution to determine final anti-HBc IgM sample status. Specificity of Access was 100.00 % (99.65 - 100.00 %) on 1,098 anti-HBc IgM negative blood donor samples, 100.00 % (98.74 - 100.00 %) on 300 anti-HBc IgM negative hospitalized patient samples and 94.08 % (89.45 - 96.75 %) on 169 anti-HBc IgM negative acute/recent and chronic HBV infected patient samples. Sensitivity was 100.00 % (98.42 - 100.00 %) on 239 anti-HBc IgM positive acute/recent and chronic HBV infected patient samples. Seroconversion panels showed mean first day of detection 3.2 days earlier with Access than with the comparator assay. Maximum reproducibility on positive samples was 8.6 % coefficient of variance (CV) and 0.048 S/CO standard deviation (SD) on negative samples. The Access anti-HBc IgM assay demonstrated excellent diagnostic and analytical performances comparable to other current CE-marked anti-HBc IgM assays.
