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. 2022 Feb 19:14:257-266.
doi: 10.2147/IJWH.S347546. eCollection 2022.

HPV E1 qPCR, a Low-Cost Alternative Assay to Roche Diagnostic Linear Array is Effective in Identifying Women at Risk for Developing Cervical Cancer

Chandrika J Piyathilake  1 , Suguna Badiga  1 , Janice L Simons  2 , Walter C Bell  3 , Pauline E Jolly  2
Affiliations

HPV E1 qPCR, a Low-Cost Alternative Assay to Roche Diagnostic Linear Array is Effective in Identifying Women at Risk for Developing Cervical Cancer

Chandrika J Piyathilake et al. Int J Womens Health. .

Abstract

Objective: Since a quantitative polymerase chain reaction (qPCR) assay targeting the E1 region of HPV genome is cost-effective/simple to perform, we evaluated the agreement between the Roche Diagnostics Linear Array (RDLA) genotyping test and qPCR-based E1 assay to detect HR-HPV genotypes that are included or not included in HPV vaccines and compared their accuracy to detect CIN 2+.

Methods: Study population included 257 African American (AA) and 266 Caucasian American (CA) diagnosed with intraepithelial neoplasia (CIN) grades ≤CIN 1 or ≥CIN 2 (CIN 2+) and tested for HPV by the RDLA and E1 assay. The concordance was determined using Gwet's AC1. The calculated positive predictive value (PPV) and negative predictive value (NPV) of the two assays were used to determine their suitability to detect CIN lesions.

Results: Overall, the E1 assay showed substantial agreement with the RDLA assay to detect any HR-HPV genotype and the agreement was higher in women diagnosed with CIN 2+ than ≤CIN 1. The concordance was largely higher in Cas than in Aas. The NPV and PPV values to detect CIN lesions were similar between the two assays.

Conclusion: Utilization of the HPV E1 assay as a tool for CC screening could be a cost-effective approach that applies to both vaccinated and unvaccinated populations.

Keywords: CIN; E1 qPCR assay; HPV; Roche Linear Diagnostic Assay; cervical intraepithelial neoplasia.

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Conflict of interest statement

The authors report no conflicts of interest for this work and have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1
Figure 1
The comparison of the PPV and NPV of the RDLA and E1 assay results for the detection of CIN 2 and CIN 3 lesions associated with any HR-HPV or with specific HR-HPVs*.
Figure 2
Figure 2
The comparison of the PPV and NPV of the RDLA and E1 assay results for the detection of CIN 2 and CIN 3 lesions associated with any HR-HPV or with specific HR-HPVs* in African Americans.
Figure 3
Figure 3
The comparison of the PPV and NPV of the RDLA and E1 assay results for the detection of CIN 2 and CIN 3 lesions associated with any HR-HPV or with specific HR-HPVs* in Caucasian Americans.
See this image and copyright information in PMC

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