alexa Direct comparison of HPV16 serological assays used to define HPV-naïve women in HPV vaccine trials.
Bioinformatics & Systems Biology

Bioinformatics & Systems Biology

Journal of Proteomics & Bioinformatics

Author(s): Safaeian M, Ghosh A, Porras C, Lin SW, Rodriguez AC,

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Abstract BACKGROUND: Two HPV serological assays, the competitive Luminex immunoassay (cLIA), and an enzyme-linked immunoassay (ELISA) against HPV16 have been used to define HPV-naïve subcohorts within large HPV vaccination trials. Some of the variation in estimated vaccine efficacies may be due to the differences in these assays used to define the HPV-naïve subgroups. To guide the interpretation of published results, we compared these assays. METHODS: Replicate enrollment sera from a stratified sample of 388 unvaccinated women from the control arm of the Costa Rica HPV 16/18 Vaccine Trial were measured for antibodies against HPV16 using cLIA and ELISA. Agreement between the assays was estimated using standard and alternative assay cutoffs. RESULTS: Using laboratory-determined seropositivity cutoffs, sampling-adjusted HPV16 seropositivity was 24.8\% by ELISA and 7.2\% by cLIA. Comparing cLIA and ELISA antibody levels based on the standard cutoffs, overall agreement was 53\% (positive-agreement = 49\%). The poor agreement was mainly driven by the higher sensitivity of the ELISA than cLIA, resulting in 30\% of the ELISA-positive sample that were cLIA-negative (none of the ELISA-negatives were cLIA-positive). Increasing ELISA cutoff to 54 ELISA units (EU)/mL (the level which maximized agreement with cLIA; ELISA standard cutoff is 8 EU/mL) resulted in higher agreement (overall agreement = 91\%; positive agreement = 78\%). CONCLUSIONS: ELISA and cLIA are different from each other based on the laboratory-determined cutoff. Increasing ELISA cutoff increased agreement with cLIA, which could facilitate comparisons among studies that use different assays. IMPACT: Keeping cLIA at the laboratory-determined cutoff but altering ELISA cutoff for seropositivity might facilitate vaccine efficacy comparisons in the naïve cohorts defined by cLIA. ©2012 AACR This article was published in Cancer Epidemiol Biomarkers Prev and referenced in Journal of Proteomics & Bioinformatics

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