Evaluation of the analytical performances of the Alinity-i HSV-1 IgG and HSV-2 IgG chemiluminescent immunoassays.

BACKGROUND

The landscape of diagnostic assays for detecting herpes simplex virus type 1 and 2 (HSV-1 and HSV-2) antibodies (IgG) has evolved over time. This study aims to evaluate the analytical performance of Alinity-i chemiluminescence immunoassays in detecting specific anti-HSV-1 and HSV-2 IgG.

METHODS

A retrospective analysis was conducted on 157 serum samples collected from 155 patients between June 2023 and July 2024. Three assays were compared: Alinity® HSV-1 and HSV-2 IgG (Abbott), Liaison® HSV-1 and HSV-2 Type Specific IgG (Diasorin), and BioPlex® 2200 HSV-1 & HSV-2 IgG (Bio-Rad). Results were interpreted based on index values. The Anti-HSV-1/HSV-2-gG2 EUROLINE Western blot was used to provide definitive conclusions in cases of discordant results.

RESULTS

The sensitivities and specificities of the Alinity-i assays were respectively 98 % and 100 % for HSV-1 IgG and 92 % and 98 % for HSV-2 IgG. The interpretation concordance among the three assays was high with Cohen's kappa values ranging from 0.82 to 0.90. Of the 27 discordant samples, Western-blot analysis identified false negatives as follows: 2 and 14 for Liaison, 3 and 5 for Alinity-i, and 2 and 0 for BioPlex, for HSV-1 and HSV-2 IgG respectively. Additionally, Western Blot revealed false positives in 3 Liaison and 1 BioPlex sample for HSV-1, and in 1 Liaison and 2 Alinity-i samples for HSV-2.

CONCLUSION

The Alinity-i HSV-1 and HSV-2 IgG serology demonstrated excellent sensitivities and specificities compared to Liaison and BioPlex assays. These findings underline the efficacy of Alinity-i in clinical diagnostics, suggesting it as a reliable tool for HSV-1 and HSV-2 antibody detection in diverse patient populations.