Evaluation of Seegene Anyplex II Performance for Detection of Human Papillomavirus Genotypes in Formalin-Fixed, Paraffin-Embedded Cervical Cancer Specimens

Haqshenas, Gholamreza and Molano, Monica and Phillips, Samuel and Balgovind, Prisha and Garland, Suzanne M. and Hawkes, David and Brotherton, Julia M. L. and Machalek, Dorothy A. and Murray, Gerald (2024) Evaluation of Seegene Anyplex II Performance for Detection of Human Papillomavirus Genotypes in Formalin-Fixed, Paraffin-Embedded Cervical Cancer Specimens. Archives of Pathology & Laboratory Medicine, 148 (3). pp. 353-358. ISSN 0003-9985,

Full text not available from this repository.

Abstract

<bold>Context.-: </bold>Detection of human papillomavirus (HPV) in formalin-fixed, paraffin-embedded (FFPE) tissues may identify the cause of lesions and has value for the development of new diagnostic assays and epidemiologic studies. Seegene Anyplex II assays are widely used for HPV screening, but their performance using FFPE samples has not been fully explored. <bold>Objective.-: </bold>To validate Anyplex II HPV HR Detection (Anyplex II, Seegene) using FFPE samples. <bold>Design.-: </bold>We used 248 stored DNA extracts from cervical cancer FFPE samples collected during 2005-2015 that tested HPV positive using the RHA kit HPV SPF10-LiPA25, v1 (SPF10, Labo Biomedical Products) HPV genotyping assay, manufacturer-validated for FFPE samples. <bold>Results.-: </bold>Of the selected 248 samples, 243 were used in our analysis. Consistent with SPF10 genotyping results, Anyplex II detected all 12 oncogenic types and had an overall HPV detection rate of 86.4% (210 of 243 samples). Anyplex II and SPF10 showed very high agreement for the detection of the 2 most important oncogenic genotypes: HPV 16 (219 of 226; 96.9%; 95% CI, 93.7-98.75) and HPV 18 (221 of 226; 97.8%; 95% CI, 94.9-99.3). <bold>Conclusions.-: </bold>Overall results showed that both platforms produced comparable HPV genotyping results, indicating the suitability of Anyplex II for FFPE samples. The Anyplex II assay has the added convenience of being an efficient, single-well semiquantitative polymerase chain reaction assay. Further optimization of Anyplex II may enhance its performance using FFPE samples by improving the detection limit.

Item Type: Article
Funders: UNSPECIFIED
Uncontrolled Keywords: HPV; Assay; Samples; Women
Subjects: R Medicine
Divisions: Faculty of Medicine > Pathology Department
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 25 Oct 2024 02:53
Last Modified: 25 Oct 2024 02:53
URI: http://eprints.um.edu.my/id/eprint/45504

Actions (login required)

View Item View Item