Sensitivity and mutant recognition of the DiaSorin liaison HBsAg assay
Abstract number: P947
Nick S., Scheiblauer H., Spranzi E., Wacker S.
Objectives: Determination of HBsAg is still indispensable for the diagnosis of HBV infection despite additional anti-HBc screening and NAT. Yet, high sensitivity and mutant recognition are the prerequisites for HBsAg detection. The European regulations require an overall sensitivity equivalent to an established device, early detection to be state of the art and recognition of virus variants. The Liaison HBsAg assay was challenged for analytical sensitivity, seroconversion sensitivity and frequently occurring HBV mutants.
Methods: Diagnostic and analytical sensitivity of the Liaison HBsAg assay were assessed using 37 commercial seroconversion panels, internationally recognised HBsAg standards (PEI HBsAg ad and ay, 2nd WHO HBsAg standard and HBsAg mutant samples (4 recombinant constructs S143L (ayw), C76Y/R169H, S53L/ I126N/ S210N, C76Y/ T143M/ F219S and 4 naturally occurring mutants G129H, M133T, G145R, T143L).
Results: Seroconversion data revealed that the Liaison HBsAg assay showed an overall clinical sensitivity in the range of European CE-marked HBsAg tests. Among the 20 HBsAg tests assessed by PEI it ranked at position 9. Analytical sensitivities of the Liaison HBsAg were 0.023 PEI U/ml relating to the PEI HBsAg ad standard and 0.038 PEI U/ml for the HBsAg ay standard. Based on the 2nd WHO HBsAg standard analytical sensitivity was 0.049 IU/ml. In addition, the Liaison HBsAg test detected all natural mutants as well as all recombinant constructs investigated.
Conclusions: Sensitivity of Liaison HBsAg assay meets the current state of the art in the sense of the European regulations. Analytical sensitivity of the Liaison HBsAg complies with the revised European requirement for 0.130 IU/ml relating to the 2nd WHO HBsAg standard. Seroconversion sensitivity is in a good range with other CE-marked assays. The assay shows no deficiencies in the detection of frequently occurring HBsAg mutants.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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