Genotype-specific agreement and accuracy of human papillomavirus DNA detection using AnyplexTM II HPV28 and XpertTM HPV among women with HIV in Lusaka, Zambia: a diagnostic accuracy analysis
6 affiliations
- 1Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
- 2Department of Reproductive, Maternal, Newborn, and Child Health, Centre for Infectious Disease Research in Zambia, Lusaka, Zambia
- 3Molecular Pathology Department, Lancet Laboratories, Johannesburg, South Africa
- 4Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, World Health Organization (IARC/WHO), Lyon, France
- 5Women and Newborn Hospital, University Teaching Hospital, Lusaka, Zambia
- 6Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA
Abstract
Objectives: The prevalence of cervicovaginal high-risk human papillomavirus (hrHPV) is high among women with human immunodeficiency virus (WHIV). Many hrHPV tests exist, but genotype-specific comparisons among WHIV are limited. We compared hrHPV detection and diagnostic accuracy using AnyplexTM II HPV 28 and XpertTM HPV among WHIV in Lusaka, Zambia.
Methods: WHIV enrolled in a cervical screening test accuracy study (05/2019-03/2021) were invited for rescreening after 36 months. Trained nurses collected the cervical cytology and biopsy samples. Cytology samples were tested using Anyplex and Xpert. Women with paired and valid hrHPV results were included. We compared hrHPV and genotype-specific prevalence, overall agreement, Cohen kappa (κ), and relative sensitivity and specificity for the detection of high-grade squamous intraepithelial lesions (HSIL).
Results: Among 230 women seen between 05/2022 and 06/2023, hrHPV prevalence was 24% (55/230) using Xpert and 36% (82/230) using Anyplex. Detection of HPV16 was higher with Anyplex (9%, 20/230) than with Xpert (6%, 13/230). Overall agreement was 85% (κ = 0.64; 95% confidence interval [CI] = 0.53-0.74). Genotype-specific agreement ranged from 88% (other hrHPV, κ = 0.66) to 96% (HPV16, κ = 0.70). For the detection of HSIL, the relative sensitivity of Anyplex compared with Xpert was 1.07 (95% CI = 0.94-1.21), and the relative specificity was 0.85 (95% CI = 0.79-0.91).
Conclusion: Agreement between Anyplex and Xpert for hrHPV detection was high, but genotype-specific detection differed, with Anyplex detecting HPV16 more frequently than Xpert. While both assays had similar sensitivity, Xpert was more specific for HSIL. The choice of assay should balance the goals of maximizing HSIL detection with minimizing overtreatment.
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BibTeX
@article{villalobos2026genotypespecific,
title = {{Genotype-specific agreement and accuracy of human papillomavirus DNA detection using AnyplexTM II HPV28 and XpertTM HPV among women with HIV in Lusaka, Zambia: a diagnostic accuracy analysis}},
author = {Nathalie Veronica Fernandez Villalobos and Misinzo Moono and John Andoh and Allison Glass and Partha Basu and Thamsanqa Madliwa and Mulindi Mwanahamuntu and Eliane Rohner and Nicola Low and Albert Manasyan and Katayoun Taghavi},
journal = {IJID Regions},
year = {2026},
month = sep,
doi = {10.1016/j.ijregi.2026.101027},
url = {https://doi.org/10.1016/j.ijregi.2026.101027},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Genotype-specific agreement and accuracy of human papillomavirus DNA detection using AnyplexTM II HPV28 and XpertTM HPV among women with HIV in Lusaka, Zambia: a diagnostic accuracy analysis
AU - Nathalie Veronica Fernandez Villalobos
AU - Misinzo Moono
AU - John Andoh
AU - Allison Glass
AU - Partha Basu
AU - Thamsanqa Madliwa
AU - Mulindi Mwanahamuntu
AU - Eliane Rohner
AU - Nicola Low
AU - Albert Manasyan
AU - Katayoun Taghavi
PY - 2026
DA - 2026/09/25
JO - IJID Regions
DO - 10.1016/j.ijregi.2026.101027
UR - https://doi.org/10.1016/j.ijregi.2026.101027
AB - Objectives: The prevalence of cervicovaginal high-risk human papillomavirus (hrHPV) is high among women with human immunodeficiency virus (WHIV). Many hrHPV tests exist, but genotype-specific comparisons among WHIV are limited. We compared hrHPV detection and diagnostic accuracy using AnyplexTM II HPV 28 and XpertTM HPV among WHIV in Lusaka, Zambia. Methods: WHIV enrolled in a cervical screening test accuracy study (05/2019-03/2021) were invited for rescreening after 36 months. Trained nurses collected the cervical cytology and biopsy samples. Cytology samples were tested using Anyplex and Xpert. Women with paired and valid hrHPV results were included. We compared hrHPV and genotype-specific prevalence, overall agreement, Cohen kappa (κ), and relative sensitivity and specificity for the detection of high-grade squamous intraepithelial lesions (HSIL). Results: Among 230 women seen between 05/2022 and 06/2023, hrHPV prevalence was 24% (55/230) using Xpert and 36% (82/230) using Anyplex. Detection of HPV16 was higher with Anyplex (9%, 20/230) than with Xpert (6%, 13/230). Overall agreement was 85% (κ = 0.64; 95% confidence interval [CI] = 0.53-0.74). Genotype-specific agreement ranged from 88% (other hrHPV, κ = 0.66) to 96% (HPV16, κ = 0.70). For the detection of HSIL, the relative sensitivity of Anyplex compared with Xpert was 1.07 (95% CI = 0.94-1.21), and the relative specificity was 0.85 (95% CI = 0.79-0.91). Conclusion: Agreement between Anyplex and Xpert for hrHPV detection was high, but genotype-specific detection differed, with Anyplex detecting HPV16 more frequently than Xpert. While both assays had similar sensitivity, Xpert was more specific for HSIL. The choice of assay should balance the goals of maximizing HSIL detection with minimizing overtreatment.
SN - 2772-7076
ER -