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 language | English |
|---|---|
| Pages (from-to) | 149-156 |
| Number of pages | 8 |
| Journal | Experimental and Molecular Pathology |
| Volume | 106 |
| DOIs | |
| Publication status | Published - 2019 Feb 1 |
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All Science Journal Classification (ASJC) codes
- Pathology and Forensic Medicine
- Molecular Biology
- Clinical Biochemistry
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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 journal › Article
TY - JOUR
T1 - Analytical performance evaluation of the HPV OncoCheck assay for detection of high-risk HPV infection in liquid-based cervical samples
AU - Wang, Hye young
AU - Kim, Hyunil
AU - Park, Sunyoung
AU - Park, Kwang Hwa
AU - Lee, Hyeyoung
PY - 2019/2/1
Y1 - 2019/2/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85059943718&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85059943718&partnerID=8YFLogxK
U2 - 10.1016/j.yexmp.2018.12.008
DO - 10.1016/j.yexmp.2018.12.008
M3 - Article
VL - 106
SP - 149
EP - 156
JO - Experimental and Molecular Pathology
T2 - Experimental and Molecular Pathology
JF - Experimental and Molecular Pathology
SN - 0014-4800
ER -