Analytical performance evaluation of the HPV OncoCheck assay for detection of high-risk HPV infection in liquid-based cervical samples

Hye young Wang, Hyunil Kim, Sunyoung Park, Kwang Hwa Park, Hyeyoung Lee

Research output: Contribution to journalArticle

Abstract

Recent studies have demonstrated low specificity (false positive) of human papillomavirus (HPV) DNA testing for the screening and diagnosis of cervical samples. Therefore, we evaluated the performance of the HPV OncoCheck assay, which is an HPV E6/E7 mRNA-based assay, for the detection of 16 high-risk (HR)-HPVs including HPV 16 and HPV 18 genotypes in cervical samples using multiplex reverse transcriptase-quantitative PCR. In the present study, the analytical performance of the assay was evaluated using 16 HPV single strand DNAs. Clinical evaluation was performed using 319 Thinprep® liquid-based cytology samples obtained from women with cervical diseases, and the HPV OncoCheck assay results were compared with those of cytological diagnosis and sequence analysis. All 16 types of HPVs were detected with a minimum detection sensitivity of 100 copies per reaction and high specificity was observed. The sensitivity and specificity of the HPV OncoCheck assay for detecting high-grade lesions were 94.1% (95% confidence interval (CI), 0.875–0.975; p <.0001) and 95.4% (95% CI, 0.868–0.989; p <.0001), and sequence analysis were 99.4% (95% CI, 0.965–0.999; p <.0001), and 98% (95% CI, 0.939–0.996; p <.0001), respectively. Moreover, the agreement between the HPV OncoCheck assay and sequence analysis for the detection of HR-HPV was 98.8% (κ = 0.98, 95% CI 0.967–0.996; p <.0001). The results of this study showed high agreement and specificity with cytological diagnoses and sequence analysis. Future studies with histological follow- up are needed to determine whether use of the HPV OncoCheck assay in cervical screening may aid detection of the most significant cervical disease while reducing false-positive results.

Original languageEnglish
Pages (from-to)149-156
Number of pages8
JournalExperimental and Molecular Pathology
Volume106
DOIs
Publication statusPublished - 2019 Feb 1

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Papillomavirus Infections
Assays
Liquids
Sequence Analysis
Human papillomavirus 16
Confidence Intervals
Screening
Cytology
RNA-Directed DNA Polymerase
DNA
Human papillomavirus 18
Multiplex Polymerase Chain Reaction
Reverse Transcriptase Polymerase Chain Reaction
Cell Biology
Genotype
Messenger RNA
Sensitivity and Specificity
Testing

All Science Journal Classification (ASJC) codes

  • Pathology and Forensic Medicine
  • Molecular Biology
  • Clinical Biochemistry

Cite this

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title = "Analytical performance evaluation of the HPV OncoCheck assay for detection of high-risk HPV infection in liquid-based cervical samples",
abstract = "Recent studies have demonstrated low specificity (false positive) of human papillomavirus (HPV) DNA testing for the screening and diagnosis of cervical samples. Therefore, we evaluated the performance of the HPV OncoCheck assay, which is an HPV E6/E7 mRNA-based assay, for the detection of 16 high-risk (HR)-HPVs including HPV 16 and HPV 18 genotypes in cervical samples using multiplex reverse transcriptase-quantitative PCR. In the present study, the analytical performance of the assay was evaluated using 16 HPV single strand DNAs. Clinical evaluation was performed using 319 Thinprep{\circledR} liquid-based cytology samples obtained from women with cervical diseases, and the HPV OncoCheck assay results were compared with those of cytological diagnosis and sequence analysis. All 16 types of HPVs were detected with a minimum detection sensitivity of 100 copies per reaction and high specificity was observed. The sensitivity and specificity of the HPV OncoCheck assay for detecting high-grade lesions were 94.1{\%} (95{\%} confidence interval (CI), 0.875–0.975; p <.0001) and 95.4{\%} (95{\%} CI, 0.868–0.989; p <.0001), and sequence analysis were 99.4{\%} (95{\%} CI, 0.965–0.999; p <.0001), and 98{\%} (95{\%} CI, 0.939–0.996; p <.0001), respectively. Moreover, the agreement between the HPV OncoCheck assay and sequence analysis for the detection of HR-HPV was 98.8{\%} (κ = 0.98, 95{\%} CI 0.967–0.996; p <.0001). The results of this study showed high agreement and specificity with cytological diagnoses and sequence analysis. Future studies with histological follow- up are needed to determine whether use of the HPV OncoCheck assay in cervical screening may aid detection of the most significant cervical disease while reducing false-positive results.",
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Analytical performance evaluation of the HPV OncoCheck assay for detection of high-risk HPV infection in liquid-based cervical samples. / Wang, Hye young; Kim, Hyunil; Park, Sunyoung; Park, Kwang Hwa; Lee, Hyeyoung.

In: Experimental and Molecular Pathology, Vol. 106, 01.02.2019, p. 149-156.

Research output: Contribution to journalArticle

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