The effectiveness of human papillomavirus load, reflected by cycle threshold values, for the triage of HPV-positive self-samples in cervical cancer screening

The effectiveness of human papillomavirus load, reflected by cycle threshold values, for the triage of HPV-positive self-samples in cervical cancer screening

Objective The performance of Cobas4800 cycle threshold value (Ct-value, reflecting viral load) combined with human papillomavirus (HPV) 16/18 genotyping was explored as a method of risk stratification to triage patients after primary HPV screening of self-collected samples. Methods The Chinese Multi...

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Veröffentlicht in:Journal of medical screening 2021-09, Vol.28 (3), p.318-324
Hauptverfasser: Song, Fangbin, Du, Hui, Wang, Chun, Huang, Xia, Qu, Xinfeng, Wei, Lihui, Belinson, Jerome L, Wu, Ruifang
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container_end_page 324
container_issue 3
container_start_page 318
container_title Journal of medical screening
container_volume 28
creator Song, Fangbin
Du, Hui
Wang, Chun
Huang, Xia
Qu, Xinfeng
Wei, Lihui
Belinson, Jerome L
Wu, Ruifang
description Objective The performance of Cobas4800 cycle threshold value (Ct-value, reflecting viral load) combined with human papillomavirus (HPV) 16/18 genotyping was explored as a method of risk stratification to triage patients after primary HPV screening of self-collected samples. Methods The Chinese Multi-site Screening Trial database was reviewed, with focus on self-collected samples, using the results of Cobas4800 HPV assay. Quartiles of Ct-values of each genotype were used for grouping and developing screening algorithms. Diagnostic accuracy for paired comparisons between algorithms was obtained using McNemar’s test. Results A total of 10,498 women were included. The Ct-values of HPV16 and other high-risk HPV were inversely correlated with the severity of cervical lesions (p 
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Methods The Chinese Multi-site Screening Trial database was reviewed, with focus on self-collected samples, using the results of Cobas4800 HPV assay. Quartiles of Ct-values of each genotype were used for grouping and developing screening algorithms. Diagnostic accuracy for paired comparisons between algorithms was obtained using McNemar’s test. Results A total of 10,498 women were included. The Ct-values of HPV16 and other high-risk HPV were inversely correlated with the severity of cervical lesions (p &lt; 0.001). Risks for cervical intraepithelial neoplasia (CIN2+/CIN3+) were significantly stratified by Ct-values from channels detecting HPV16 and other high-risk HPV types. “HPV with HPV16/18 and reflex Ct &lt;33.7” (algorithm G) achieved a favorable sensitivity to “HPV with atypical squamous cells of undetermined significance or worse (≥ASCUS)” (81.9% vs. 70.1% for CIN2+, p &lt; 0.001), a comparable sensitivity to “HPV with HPV16/18 reflex cytology ≥ASCUS” (81.9% vs. 81.3% for CIN2+, p &gt; 0.05), and resulted in a slightly lower specificity than the latter two algorithms (92.6% vs. 97.4% and 95.4% respectively for CIN2+, p &lt; 0.05). However, algorithm G achieved a comparable sensitivity to HPV testing alone for CIN3+, and reduced the colposcopy referral rate from 13.7% for HPV testing alone to 8.4%. Conclusions HPV viral loads reflected by Ct-values are associated with the severity of cervical lesions. Ct-values with an appropriate cut-off of 33.7, combined with HPV16/18 genotyping, represent a promising triage of HPV-positive women particularly for self-collected samples.</description><identifier>ISSN: 0969-1413</identifier><identifier>EISSN: 1475-5793</identifier><identifier>DOI: 10.1177/0969141320943634</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><ispartof>Journal of medical screening, 2021-09, Vol.28 (3), p.318-324</ispartof><rights>The Author(s) 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c314t-f26dcf361f0cb18b5540e07cc2ccd7241bc6123cf20223ebcf199719b2172ed53</citedby><cites>FETCH-LOGICAL-c314t-f26dcf361f0cb18b5540e07cc2ccd7241bc6123cf20223ebcf199719b2172ed53</cites><orcidid>0000-0002-3017-0110</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/0969141320943634$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/0969141320943634$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,780,784,21819,27924,27925,43621,43622</link.rule.ids></links><search><creatorcontrib>Song, Fangbin</creatorcontrib><creatorcontrib>Du, Hui</creatorcontrib><creatorcontrib>Wang, Chun</creatorcontrib><creatorcontrib>Huang, Xia</creatorcontrib><creatorcontrib>Qu, Xinfeng</creatorcontrib><creatorcontrib>Wei, Lihui</creatorcontrib><creatorcontrib>Belinson, Jerome L</creatorcontrib><creatorcontrib>Wu, Ruifang</creatorcontrib><creatorcontrib>CHIMUST team</creatorcontrib><title>The effectiveness of human papillomavirus load, reflected by cycle threshold values, for the triage of HPV-positive self-samples in cervical cancer screening</title><title>Journal of medical screening</title><description>Objective The performance of Cobas4800 cycle threshold value (Ct-value, reflecting viral load) combined with human papillomavirus (HPV) 16/18 genotyping was explored as a method of risk stratification to triage patients after primary HPV screening of self-collected samples. Methods The Chinese Multi-site Screening Trial database was reviewed, with focus on self-collected samples, using the results of Cobas4800 HPV assay. Quartiles of Ct-values of each genotype were used for grouping and developing screening algorithms. Diagnostic accuracy for paired comparisons between algorithms was obtained using McNemar’s test. Results A total of 10,498 women were included. The Ct-values of HPV16 and other high-risk HPV were inversely correlated with the severity of cervical lesions (p &lt; 0.001). Risks for cervical intraepithelial neoplasia (CIN2+/CIN3+) were significantly stratified by Ct-values from channels detecting HPV16 and other high-risk HPV types. “HPV with HPV16/18 and reflex Ct &lt;33.7” (algorithm G) achieved a favorable sensitivity to “HPV with atypical squamous cells of undetermined significance or worse (≥ASCUS)” (81.9% vs. 70.1% for CIN2+, p &lt; 0.001), a comparable sensitivity to “HPV with HPV16/18 reflex cytology ≥ASCUS” (81.9% vs. 81.3% for CIN2+, p &gt; 0.05), and resulted in a slightly lower specificity than the latter two algorithms (92.6% vs. 97.4% and 95.4% respectively for CIN2+, p &lt; 0.05). However, algorithm G achieved a comparable sensitivity to HPV testing alone for CIN3+, and reduced the colposcopy referral rate from 13.7% for HPV testing alone to 8.4%. Conclusions HPV viral loads reflected by Ct-values are associated with the severity of cervical lesions. Ct-values with an appropriate cut-off of 33.7, combined with HPV16/18 genotyping, represent a promising triage of HPV-positive women particularly for self-collected samples.</description><issn>0969-1413</issn><issn>1475-5793</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1UM1OwzAMjhBIjMGdYx5ghTjpz3pEEzCkSXAYXKvUddZMWVsla6U9DO9Kq3FC4mTL34_9mbF7EA8AWfYo8jSHGJQUeaxSFV-wGcRZEiVZri7ZbIKjCb9mNyHshRAKYDlj39uaOBlDeLQDNRQCbw2v-4NueKc761x70IP1feCu1dWCezJuJFPFyxPHEzrix9pTqFtX8UG7nsKCm9aP0xHxVu9oclx_fEVdG-y0hQdyJgr60DkK3DYcyQ8WteOom7HnAT1RY5vdLbsy2gW6-61z9vnyvF2to83769vqaROhgvgYGZlWaFQKRmAJyzJJYkEiQ5SIVSZjKDEFqdBIIaWiEg3keQZ5KSGTVCVqzsTZF30bwhix6Lw9aH8qQBTTe4u_7x0l0VkSxoTFvu19M174P_8HtRx9fQ</recordid><startdate>202109</startdate><enddate>202109</enddate><creator>Song, Fangbin</creator><creator>Du, Hui</creator><creator>Wang, Chun</creator><creator>Huang, Xia</creator><creator>Qu, Xinfeng</creator><creator>Wei, Lihui</creator><creator>Belinson, Jerome L</creator><creator>Wu, Ruifang</creator><general>SAGE Publications</general><scope>AAYXX</scope><scope>CITATION</scope><orcidid>https://orcid.org/0000-0002-3017-0110</orcidid></search><sort><creationdate>202109</creationdate><title>The effectiveness of human papillomavirus load, reflected by cycle threshold values, for the triage of HPV-positive self-samples in cervical cancer screening</title><author>Song, Fangbin ; Du, Hui ; Wang, Chun ; Huang, Xia ; Qu, Xinfeng ; Wei, Lihui ; Belinson, Jerome L ; Wu, Ruifang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c314t-f26dcf361f0cb18b5540e07cc2ccd7241bc6123cf20223ebcf199719b2172ed53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Song, Fangbin</creatorcontrib><creatorcontrib>Du, Hui</creatorcontrib><creatorcontrib>Wang, Chun</creatorcontrib><creatorcontrib>Huang, Xia</creatorcontrib><creatorcontrib>Qu, Xinfeng</creatorcontrib><creatorcontrib>Wei, Lihui</creatorcontrib><creatorcontrib>Belinson, Jerome L</creatorcontrib><creatorcontrib>Wu, Ruifang</creatorcontrib><creatorcontrib>CHIMUST team</creatorcontrib><collection>CrossRef</collection><jtitle>Journal of medical screening</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Song, Fangbin</au><au>Du, Hui</au><au>Wang, Chun</au><au>Huang, Xia</au><au>Qu, Xinfeng</au><au>Wei, Lihui</au><au>Belinson, Jerome L</au><au>Wu, Ruifang</au><aucorp>CHIMUST team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effectiveness of human papillomavirus load, reflected by cycle threshold values, for the triage of HPV-positive self-samples in cervical cancer screening</atitle><jtitle>Journal of medical screening</jtitle><date>2021-09</date><risdate>2021</risdate><volume>28</volume><issue>3</issue><spage>318</spage><epage>324</epage><pages>318-324</pages><issn>0969-1413</issn><eissn>1475-5793</eissn><abstract>Objective The performance of Cobas4800 cycle threshold value (Ct-value, reflecting viral load) combined with human papillomavirus (HPV) 16/18 genotyping was explored as a method of risk stratification to triage patients after primary HPV screening of self-collected samples. Methods The Chinese Multi-site Screening Trial database was reviewed, with focus on self-collected samples, using the results of Cobas4800 HPV assay. Quartiles of Ct-values of each genotype were used for grouping and developing screening algorithms. Diagnostic accuracy for paired comparisons between algorithms was obtained using McNemar’s test. Results A total of 10,498 women were included. The Ct-values of HPV16 and other high-risk HPV were inversely correlated with the severity of cervical lesions (p &lt; 0.001). Risks for cervical intraepithelial neoplasia (CIN2+/CIN3+) were significantly stratified by Ct-values from channels detecting HPV16 and other high-risk HPV types. “HPV with HPV16/18 and reflex Ct &lt;33.7” (algorithm G) achieved a favorable sensitivity to “HPV with atypical squamous cells of undetermined significance or worse (≥ASCUS)” (81.9% vs. 70.1% for CIN2+, p &lt; 0.001), a comparable sensitivity to “HPV with HPV16/18 reflex cytology ≥ASCUS” (81.9% vs. 81.3% for CIN2+, p &gt; 0.05), and resulted in a slightly lower specificity than the latter two algorithms (92.6% vs. 97.4% and 95.4% respectively for CIN2+, p &lt; 0.05). However, algorithm G achieved a comparable sensitivity to HPV testing alone for CIN3+, and reduced the colposcopy referral rate from 13.7% for HPV testing alone to 8.4%. Conclusions HPV viral loads reflected by Ct-values are associated with the severity of cervical lesions. Ct-values with an appropriate cut-off of 33.7, combined with HPV16/18 genotyping, represent a promising triage of HPV-positive women particularly for self-collected samples.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><doi>10.1177/0969141320943634</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-3017-0110</orcidid></addata></record>
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title The effectiveness of human papillomavirus load, reflected by cycle threshold values, for the triage of HPV-positive self-samples in cervical cancer screening
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