Direct comparison of HPV16 serological assays used to define HPV-naïve women in HPV vaccine trials

Mahboobeh Safaeian, Arpita Ghosh, Carolina Porras, Shih Wen Lin, Ana Cecilia Rodriguez, Mark Schiffman, Sholom Wacholder, Troy Kemp, Paula Gonzalez, Nicolas Wentzensen, Mark Esser, Ariane Meuree, Katie Matys, Wim Quint, Leen Jan Van Doorn, Mark E. Sherman, Rolando Herrero, Ligia A. Pinto, Allan Hildesheim

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1547-1554
Number of pages8
JournalCancer Epidemiology Biomarkers and Prevention
Issue number9
StatePublished - Sep 2012

ASJC Scopus subject areas

  • Medicine(all)


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