ArticleJournal of clinical laboratory analysis2026
Preliminary Development and Assessment of a Multiplex Assay for Human Papillomavirus Antibody Detection Using Commercial L1 Proteins.
Article in Journal of clinical laboratory analysis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Preliminary Development and Assessment of a Multiplex Assay for Human Papillomavirus Antibody Detection Using Commercial L1 Proteins.Journal of clinical laboratory analysis · 2026Article
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Authors and funding
12 authors.
Funding
Abstract
backgroundHuman papillomavirus (HPV)-associated cancers are preventable with vaccination. Serologic assays monitor antibody responses, but their complexity and cost pose limitations when evaluating population level immunity. We developed an L1-based assay for the detection of multiple type-specific HPV antibodies.
methodsThe Luminex-based assay used recombinant L1 proteins from seven HPVs (HPV-6/11/16/18/35/45/58) for the detection of type-specific immunoglobulin (Ig)G and IgA. Cutoffs were established using plasma from infants and children. The assay was optimized and qualified using a sample set from a blinded proficiency panel developed at the Frederick National Laboratory for Cancer Research.
resultsSensitivity and specificity for anti-HPV-6/11/16/18/58 IgG were 100% at the Mean + 3 standard deviation [SD] and Mean + 5 SD thresholds. Sensitivity for HPV-45 was 100% and 92.9% at the +3 SD and +5 SD thresholds, respectively. IgA detection showed moderate positivity among vaccinated individuals, with peak estimates of 96.4% (HPV-11) and 85.7% (HPV-58) at the +3 SD threshold. IgA was correlated with IgG (Spearman's ρ = 0.74). The L1-assay differentiated high, intermediate, low, and negative response groups from the blinded samples for all HPV genotypes (p < 0.0001).
conclusionThe L1-binding assay has the potential to be a scalable option for high-throughput detection of broad-spectrum HPV immunoglobulins, but further standardization and validation are needed.
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